Publications by authors named "Donna Mazloomdoost"

59 Publications

Improved body image after uterovaginal prolapse surgery with or without hysterectomy.

Int Urogynecol J 2021 Aug 25. Epub 2021 Aug 25.

Albany Medical College, Albany NY and University of New Mexico, Albuquerque, NM, USA.

Introduction And Hypothesis: The objective was to compare body image and sexual activity and function changes up to 3 years after sacrospinous ligament fixation with graft hysteropexy or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy).

Methods: This was a planned secondary analysis of a multi-center randomized trial of women undergoing prolapse repair with mesh hysteropexy versus hysterectomy. Women were masked to intervention. The modified Body Image Scale (BIS), sexual activity status, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) scores were reported at baseline and 1.5, 6, 12, 18, 24, and 36 months after surgery. We compared mean BIS and PISQ-IR scores, the proportion of women whose BIS scores met a distribution-based estimate of the minimally important difference (MID), and sexual activity status. Comparisons were analyzed with linear and logistic repeated measures models adjusted for site, intervention, visit, and intervention by visit interaction.

Results: Eighty-eight women underwent mesh hysteropexy; 87 underwent hysterectomy. Women were similar with regard to baseline characteristics, mean age 65.9 ± 7.3 years, and most had stage III or IV prolapse (81%). Baseline mean BIS scores were not significantly different, improved in both groups by 1.5 months, and were sustained through 36 months with no differences between groups (all p > 0.05). The estimated BIS MID was 3; and by 36 months, more women in the mesh hysteropexy group achieved the MID than in the hysterectomy group (62% vs 44%, p = 0.04). The makeup of the sexually active cohort changed throughout the study, making function comparisons difficult.

Conclusions: Body image improves following prolapse surgery whether or not hysterectomy is performed or transvaginal mesh is used at the time of repair; sexual activity status changes over time following prolapse surgery.
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http://dx.doi.org/10.1007/s00192-021-04954-0DOI Listing
August 2021

Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence.

Am J Obstet Gynecol 2021 Jul 21. Epub 2021 Jul 21.

Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.

Background: The urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence.

Objective: This study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence.

Study Design: This cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models.

Results: Objective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P<.05) for both responders and nonresponders. Overall, predominant operational taxonomic units (genera) were Lactobacillus, Gardnerella, Tepidimonas, Escherichia, Streptococcus, and Prevotella. Operational taxonomic units from baseline urine samples were not significantly associated (P threshold=.05) with surgical treatment responses. A greater abundance of baseline vaginal Lactobacillus was associated with an objective response (P=.04) and Prevotella with an objective nonresponse (P=.01). Adjusting for age, only a greater abundance of baseline vaginal Prevotella was associated with an objective nonresponse (P=.01). Moreover, less abundant vaginal operational taxonomic units were associated with objective and subjective responses and persistent urinary incontinence symptoms (P<.05).

Conclusion: Women meeting a 70% reduction of urinary incontinence treatment episodes (objective responders) had greater vaginal Lactobacillus at the time of the surgical procedure; however, controlling for age diminished this association. Women not meeting a 70% reduction of urinary incontinence episodes 1 year after a midurethral sling operation had greater vaginal Prevotella at the time of the midurethral sling operation. Further research is needed to determine whether therapy altering the vaginal microbiome may impact surgical treatment responses in women with mixed urinary incontinence.
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http://dx.doi.org/10.1016/j.ajog.2021.07.008DOI Listing
July 2021

Risk Factors for Urinary Retention After Colpocleisis.

Female Pelvic Med Reconstr Surg 2021 08;27(8):488-492

Department of Obstetrics and Gynecology, INOVA Fairfax Medical Campus, Falls Church.

Objectives: Transient urinary retention occurs frequently after pelvic organ prolapse surgery. While the prevalence of postoperative urinary retention has been reported for reconstructive procedures, a paucity of data exists for colpocleisis. The objectives of this retrospective cohort study were to identify risk factors for transient urinary retention after colpocleisis and to determine the rate of its occurrence.

Methods: A retrospective chart review was performed for patients undergoing colpocleisis from January 2015 to December 2019 in a high-volume urogynecology practice. Patients were excluded if they required prolonged catheterization postoperatively because of a surgical complication or used a catheter before surgery, or if a suprapubic catheter was placed during surgery. Potential patient and procedural risk factors were analyzed. Transient urinary retention was diagnosed if patients failed their postoperative voiding trial and went home with a catheter.

Results: A total of 172 patients met the inclusion criteria. The incidence of transient postoperative urinary retention was 55%, with rates of 36.7% with LeFort colpocleisis, 51.5% with posthysterectomy colpocleisis, and 64.9% with colpocleisis with concomitant hysterectomy. Logistic regression revealed an increased risk of postoperative urinary retention if hysterectomy was performed at the time of colpocleisis (odds ratio, 2.9; confidence interval, 1.23-6.84; P = 0.015). Patient age, prolapse severity, preoperative postvoid residual volume, and concomitant anti-incontinence procedure were not associated with transient postoperative urinary retention.

Conclusions: Transient urinary retention occurs in more than half of patients after colpocleisis. Patients undergoing concomitant hysterectomy have the highest risk of postoperative urinary retention. Surgeons can use this information both for counseling and management decisions for individual patients.
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http://dx.doi.org/10.1097/SPV.0000000000001078DOI Listing
August 2021

Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

Am J Obstet Gynecol 2021 Jul 6. Epub 2021 Jul 6.

Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC.

Background: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking.

Objective: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed.

Study Design: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile.

Results: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years.

Conclusion: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.
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http://dx.doi.org/10.1016/j.ajog.2021.06.099DOI Listing
July 2021

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

Obstet Gynecol 2021 Aug;138(2):199-207

Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California; the Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico; the Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; the Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.

Objective: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.

Methods: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.

Results: One hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group.

Conclusions: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB.

Clinical Trial Registration: ClinicalTrials.gov, NCT01959347.
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http://dx.doi.org/10.1097/AOG.0000000000004444DOI Listing
August 2021

Subgroups of failure after surgery for pelvic organ prolapse and associations with quality of life outcomes: a longitudinal cluster analysis.

Am J Obstet Gynecol 2021 Jun 19. Epub 2021 Jun 19.

Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD.

Background: Treatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies.

Objective: This study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year.

Study Design: Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster.

Results: Surgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster.

Conclusion: In particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.
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http://dx.doi.org/10.1016/j.ajog.2021.06.068DOI Listing
June 2021

Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.

Am J Obstet Gynecol 2021 Jun 1. Epub 2021 Jun 1.

Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.

Background: Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies.

Objective: This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse.

Study Design: This multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests.

Results: Of the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15).

Conclusion: The primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.
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http://dx.doi.org/10.1016/j.ajog.2021.05.041DOI Listing
June 2021

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

Female Pelvic Med Reconstr Surg 2021 May 4. Epub 2021 May 4.

From the Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, PA Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego Health, San Diego, CA Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's & Infants Hospital, Providence, RI Department of Obstetrics and Gynecology, Duke University Medical Center, Durham Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC Albany Medical College, Albany, NY University of New Mexico, Albuquerque, NM Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.

Objectives: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage.

Methods: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function.

Results: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks.

Conclusions: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.
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http://dx.doi.org/10.1097/SPV.0000000000001050DOI Listing
May 2021

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

Am J Obstet Gynecol 2021 08 12;225(2):153.e1-153.e31. Epub 2021 Mar 12.

Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.

Background: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market.

Objective: Our objective was to compare the efficacy and adverse events of these 2 procedures.

Study Design: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes.

Results: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively.

Conclusion: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.
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http://dx.doi.org/10.1016/j.ajog.2021.03.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8328912PMC
August 2021

Recommended standardized anatomic terminology of the posterior female pelvis and vulva based on a structured medical literature review.

Am J Obstet Gynecol 2021 08 9;225(2):169.e1-169.e16. Epub 2021 Mar 9.

Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI.

Background: Anatomic terminology in both written and verbal forms has been shown to be inaccurate and imprecise.

Objective: Here, we aimed to (1) review published anatomic terminology as it relates to the posterior female pelvis, posterior vagina, and vulva; (2) compare these terms to "Terminologia Anatomica," the internationally standardized terminology; and (3) compile standardized anatomic terms for improved communication and understanding.

Study Design: From inception of the study to April 6, 2018, MEDLINE database was used to search for 40 terms relevant to the posterior female pelvis and vulvar anatomy. Furthermore, 11 investigators reviewed identified abstracts and selected those reporting on posterior female pelvic and vulvar anatomy for full-text review. In addition, 11 textbook chapters were included in the study. Definitions of all pertinent anatomic terms were extracted for review.

Results: Overall, 486 anatomic terms were identified describing the vulva and posterior female pelvic anatomy, including the posterior vagina. "Terminologia Anatomica" has previously accepted 186 of these terms. Based on this literature review, we proposed the adoption of 11 new standardized anatomic terms, including 6 regional terms (anal sphincter complex, anorectum, genital-crural fold, interlabial sulcus, posterior vaginal compartment, and sacrospinous-coccygeus complex), 4 structural terms (greater vestibular duct, anal cushions, nerve to the levator ani, and labial fat pad), and 1 anatomic space (deep postanal space). In addition, the currently accepted term rectovaginal fascia or septum was identified as controversial and requires further research and definition before continued acceptance or rejection in medical communication.

Conclusion: This study highlighted the variability in the anatomic nomenclature used in describing the posterior female pelvis and vulva. Therefore, we recommended the use of standardized terminology to improve communication and education across medical and anatomic disciplines.
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http://dx.doi.org/10.1016/j.ajog.2021.02.033DOI Listing
August 2021

Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse.

Am J Obstet Gynecol 2021 04 8;224(4):362.e1-362.e11. Epub 2020 Oct 8.

Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.

Background: The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries.

Objective: This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions.

Study Design: Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel "intermittent" success and failure over time.

Results: Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores.

Conclusion: True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of "surgical success" at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.
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http://dx.doi.org/10.1016/j.ajog.2020.10.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009767PMC
April 2021

Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair.

Obstet Gynecol 2020 11;136(5):933-941

Division of Urogynecology, Department of Obstetrics & Gynecology, Kaiser Permanente Downey, Downey, California; the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, La Jolla, California; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.

Objective: To assess independent risk factors for surgical failure and worsening pelvic floor symptoms within 5 years after vaginal prolapse surgery.

Methods: This secondary analysis includes OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) (n=374) and E-OPTIMAL (Extended) (n=285) trial participants. Surgical failure was defined as apical descent greater than one third of the total vaginal length, anterior or posterior vaginal wall past the hymen, subsequent surgery or bothersome vaginal bulge. Worsening pelvic floor symptoms were defined as increases from baseline as large as the minimally important difference for subscale scores of the Pelvic Floor Distress Inventory: 11 for the Urinary Distress Inventory and Colorectal-Anal Distress Inventory and 34.3 for the Pelvic Organ Prolapse Distress Inventory. Outcomes were measured at 6 months then 1, 2, 3, 4, and 5 years. Chi-square and t test results from bivariate models and clinical relevance were used to inform final models.

Results: Baseline risk factors for surgical failure were Hispanic ethnicity (adjusted odds ratio [aOR] 1.92, 95% CI 1.17-3.15), perineal body (aOR 1.34, 95% CI 1.09-1.63), and pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 1.16, 95% CI 1.05-1.28). Risk factors for worsening of pelvic floor symptoms were pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 0.75, 95% CI 0.60-0.94) for worsening Pelvic Organ Prolapse Distress Inventory score, vaginal deliveries (aOR 1.26, 95% CI 1.10-1.44) and pretreatment Urinary Distress Inventory score (aOR 0.86, 95% CI 0.80-0.93) for worsening Urinary Distress Inventory score, and age (aOR 1.03, 95% CI 1.01-1.05) and pretreatment Colorectal-Anal Distress Inventory score (aOR 0.95, 95% CI 0.92-0.98) for worsening Colorectal-Anal Distress Inventory score.

Conclusions: Hispanic ethnicity, larger preoperative perineal body, and higher pretreatment Pelvic Organ Prolapse Distress Inventory scores were risk factors for surgical failure up to 5 years after vaginal prolapse repair. Participants with higher baseline Pelvic Floor Distress Inventory scores were less likely to worsen. Risk factors for worsening Urinary Distress Inventory and Colorectal-Anal Distress Inventory scores included more vaginal deliveries and increased age, respectively.

Clinical Trial Registration: NCT00597935, NCT01166373.
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http://dx.doi.org/10.1097/AOG.0000000000004092DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7842362PMC
November 2020

Performance, acceptability, and validation of a phone application bowel diary.

Neurourol Urodyn 2020 11 22;39(8):2480-2489. Epub 2020 Sep 22.

Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.

Aims: To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).

Methods: Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).

Results: Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.

Conclusion: The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.
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http://dx.doi.org/10.1002/nau.24520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7680657PMC
November 2020

Immediate Postoperative Pelvic Organ Prolapse Quantification Measures and 2-Year Risk of Prolapse Recurrence.

Obstet Gynecol 2020 10;136(4):792-801

Virginia Commonwealth University Health Center, Richmond, Virginia; Duke University Medical Center, Durham, North Carolina; University of Pittsburgh, Magee-Women's Hospital, Pittsburgh, Pennsylvania; Brown University/Women's and Infants Hospital, Providence, Rhode Island; Southern California Permanente Medical Group, Pasadena, California; UT Southwestern Medical Center, Dallas, Texas; University of Pennsylvania, Philadelphia, Pennsylvania; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, Maryland; and RTI International, Research Triangle Park, North Carolina.

Objective: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction.

Methods: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored.

Results: This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9-2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1-2.3) and surgical failure (aOR 1.5; 95% CI 1.0-2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50-0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function.

Conclusion: A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.
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http://dx.doi.org/10.1097/AOG.0000000000004043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526641PMC
October 2020

Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?

Female Pelvic Med Reconstr Surg 2021 01;27(1):e202-e207

Division of Female Pelvic Medicine and Reconstructive Surgery, University of California, San Diego, San Diego, CA.

Objectives: There is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity.

Methods: This is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22.

Results: A total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138).

Conclusions: In this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.
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http://dx.doi.org/10.1097/SPV.0000000000000893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793633PMC
January 2021

Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study.

Int Urogynecol J 2021 Apr 1;32(4):809-818. Epub 2020 Sep 1.

Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, Durham, NC, USA.

Introduction And Hypothesis: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse.

Methods: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the "true mid-sagittal" plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery.

Results: Recruitment and MRI trials of 94 participants were completed by May 2018.

Conclusions: Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.
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http://dx.doi.org/10.1007/s00192-020-04511-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917148PMC
April 2021

Report of the National Cancer Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development-sponsored workshop: gynecology and women's health-benign conditions and cancer.

Am J Obstet Gynecol 2020 12 21;223(6):796-808. Epub 2020 Aug 21.

Gynecologic Health and Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. Electronic address:

The Division of Cancer Prevention and the Division of Cancer Biology at the National Cancer Institute and the Gynecologic Health and Disease Branch in the National Institute of Child Health and Human Development organized a workshop in April 2019 to explore current insights into the progression of gynecologic cancers from benign conditions. Working groups were formed based on 3 gynecologic disease types: (1) Endometriosis or Endometrial Cancer and Endometrial-Associated Ovarian Cancer, (2) Uterine Fibroids (Leiomyoma) or Leiomyosarcoma, and (3) Adenomyosis or Adenocarcinoma. In this report, we highlight the key questions and current challenges that emerged from the working group discussions and present potential research opportunities that may advance our understanding of the progression of gynecologic benign conditions to cancer.
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http://dx.doi.org/10.1016/j.ajog.2020.08.049DOI Listing
December 2020

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

Obstet Gynecol 2020 09;136(3):482-491

Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California; the Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico; the Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; the Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.

Objective: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.

Methods: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.

Results: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.

Conclusion: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.

Clinical Trial Registration: ClinicalTrials.gov, NCT01959347.
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http://dx.doi.org/10.1097/AOG.0000000000003989DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483953PMC
September 2020

Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse.

Obstet Gynecol 2020 09;136(3):492-500

Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego Health Systems, San Diego, California; Social, Statistical & Environmental Sciences, RTI International, Research Triangle Park, North Carolina; the Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; the Department of Obstetrics & Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas; the Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania; the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.

Objective: To describe sexual activity and risks for dyspareunia after pelvic organ prolapse surgery.

Methods: This was a secondary analysis of data from four randomized trials conducted between 2002 and 2018. Standard assessments and validated measures of sexual function were assessed at baseline and at 12 months postoperatively. Anterior apical surgeries were grouped by approach: transvaginal native tissue repairs, transvaginal mesh or graft-augmented repairs, and abdominal sacrocolpopexy. Additional surgeries, which included posterior repair, hysterectomy, and slings, were analyzed. Bivariate analyses and logistic regression models identified risk factors for postoperative dyspareunia.

Results: Of the 1,337 women enrolled in the trials, 932 had sufficient outcome data to determine dyspareunia status. Of these before surgery, 445 (47.8%) were sexually active without dyspareunia, 89 (9.6%) were sexually active with dyspareunia, 93 (10.0%) were not sexually active owing to fear of dyspareunia, and 305 (32.7%) were not sexually active for other reasons. At 12 months, dyspareunia or fear of dyspareunia was present in 63 of 627 (10.0%); occurred de novo in 17 of 445 (3.8%) and resolved in 136 of 182 (74.7%). Multivariable regression demonstrated baseline dyspareunia as the only factor associated with postoperative dyspareunia (adjusted odds ratio 7.8, 95% CI 4.2-14.4). No other factors, including surgical approach, were significantly associated with postoperative dyspareunia. Too few had de novo dyspareunia to perform modeling.

Conclusion: Dyspareunia is common in one in five women before undergoing prolapse surgery. Surgical repair resolves dyspareunia in three out of four women with low rates of de novo dyspareunia at less than 4%. Preoperative dyspareunia appears to be the only predictor of postoperative dyspareunia.

Clinical Trial Registration: ClinicalTrials.gov, NCT00065845, NCT00460434, NCT00597935, and NCT01802281.
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http://dx.doi.org/10.1097/AOG.0000000000003992DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483870PMC
September 2020

Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.

Female Pelvic Med Reconstr Surg 2021 01;27(1):e112-e117

RTI International, Research Triangle Park, NC.

Objectives: The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time.

Methods: This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient.

Results: To date, the index trial has completed enrollment, and follow-up is ongoing.

Conclusions: The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.
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http://dx.doi.org/10.1097/SPV.0000000000000845DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087185PMC
January 2021

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

Female Pelvic Med Reconstr Surg 2021 01;27(1):e106-e111

University of Alabama at Birmingham, Birmingham, AL.

Objective: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP.

Methods: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification.

Conclusions: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.
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http://dx.doi.org/10.1097/SPV.0000000000000833DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381379PMC
January 2021

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.

Int Urogynecol J 2020 10 7;31(10):2155-2164. Epub 2020 Mar 7.

Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.

Introduction And Hypothesis: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.

Methods: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.

Results: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.

Conclusions: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.
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http://dx.doi.org/10.1007/s00192-020-04271-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483223PMC
October 2020

Reply by Authors.

J Urol 2020 05 11;203(5):977. Epub 2020 Feb 11.

Social, Statistical and Environmental Sciences Group, RTI International, Research Triangle Park, North Carolina.

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http://dx.doi.org/10.1097/JU.0000000000000656.02DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232841PMC
May 2020

Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.

Female Pelvic Med Reconstr Surg 2020 07;26(7):415-424

Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.

Objective: The objective of this study was to present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe), which compares the efficacy and safety of 3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy.

Methods: Patient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/benefits of each technique, a noninferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the 2 mesh repairs to NT transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen), and no prolapse retreatment, with a minimum follow-up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function.

Results: Randomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase.

Conclusions: This report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus NT apical repairs.
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http://dx.doi.org/10.1097/SPV.0000000000000803DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7326314PMC
July 2020

Standardized terminology of apical structures in the female pelvis based on a structured medical literature review.

Am J Obstet Gynecol 2020 03 2;222(3):204-218. Epub 2019 Dec 2.

Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.

The objectives of this study were to review the published literature and selected textbooks, to compare existing usage to that in Terminologia Anatomica, and to compile standardized anatomic nomenclature for the apical structures of the female pelvis. MEDLINE was searched from inception until May 30, 2017, based on 33 search terms generated by group consensus. Resulting abstracts were screened by 11 reviewers to identify pertinent studies reporting on apical female pelvic anatomy. Following additional focused screening for rarer terms and selective representative random sampling of the literature for common terms, accepted full-text manuscripts and relevant textbook chapters were extracted for anatomic terms related to apical structures. From an initial total of 55,448 abstracts, 193 eligible studies were identified for extraction, to which 14 chapters from 9 textbooks were added. In all, 293 separate structural terms were identified, of which 184 had Terminologia Anatomica-accepted terms. Inclusion of several widely used regional terms (vaginal apex, adnexa, cervico-vaginal junction, uretero-vesical junction, and apical segment), structural terms (vesicouterine ligament, paracolpium, mesoteres, mesoureter, ovarian venous plexus, and artery to the round ligament) and spaces (vesicocervical, vesicovaginal, presacral, and pararectal) not included in Terminologia Anatomica is proposed. Furthermore, 2 controversial terms (lower uterine segment and supravaginal septum) were identified that require additional research to support or refute continued use in medical communication. This study confirms and identifies inconsistencies and gaps in the nomenclature of apical structures of the female pelvis. Standardized terminology should be used when describing apical female pelvic structures to facilitate communication and to promote consistency among multiple academic, clinical, and surgical disciplines.
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http://dx.doi.org/10.1016/j.ajog.2019.11.1262DOI Listing
March 2020

Impact of treatment for fecal incontinence on constipation symptoms.

Am J Obstet Gynecol 2020 06 23;222(6):590.e1-590.e8. Epub 2019 Nov 23.

RTI International, Research Triangle Park, NC.

Objective: Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment.

Study Design: This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks.

Results: At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4).

Conclusion: Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.
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http://dx.doi.org/10.1016/j.ajog.2019.11.1256DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242126PMC
June 2020

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

J Urol 2020 05 18;203(5):969-977. Epub 2019 Nov 18.

Social, Statistical and Environmental Sciences Group, RTI International, Research Triangle Park, North Carolina.

Purpose: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence.

Materials And Methods: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.

Results: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years.

Conclusions: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.
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http://dx.doi.org/10.1097/JU.0000000000000656DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204548PMC
May 2020

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

JAMA 2019 09;322(11):1054-1065

Research Triangle International, Research Triangle Park, North Carolina.

Importance: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.

Objective: To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.

Design, Setting, Participants: At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.

Interventions: Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.

Main Outcomes And Measures: The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.

Results: A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).

Conclusions And Relevance: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.
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http://dx.doi.org/10.1001/jama.2019.12812DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6749543PMC
September 2019

Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.

JAMA 2019 09;322(11):1066-1076

Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.

Importance: Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.

Objective: To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.

Design, Setting, And Participants: Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.

Interventions: Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).

Main Outcomes And Measures: The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.

Results: Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).

Conclusions And Relevance: Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.

Trial Registration: ClinicalTrials.gov Identifier: NCT01959347.
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http://dx.doi.org/10.1001/jama.2019.12467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6749544PMC
September 2019

Antibiotic Prophylaxis During Catheter-Managed Postoperative Urinary Retention After Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

Obstet Gynecol 2019 10;134(4):727-735

UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania; MedStar Washington Hospital Center, Washington, DC; Washington University in St. Louis, St. Louis, Missouri; UT Southwestern Medical Center, Dallas, Texas; the University of Iowa Hospitals and Clinics, Iowa City, Iowa; and Advantia Health, Silver Spring, Maryland.

Objective: To estimate whether nitrofurantoin prophylaxis decreases the incidence of culture-documented urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery.

Methods: This double-blind, placebo-controlled, randomized trial was conducted at five academic institutions. Women with urinary retention after surgery for prolapse or incontinence were randomized to oral nitrofurantoin 100 mg daily during indwelling or clean intermittent self-catheterization. The primary outcome was the incidence of symptomatic urinary tract infection within 6 weeks of surgery, confirmed by culture demonstrating more than 1,000 colony forming units per milliliter of uropathogenic bacteria. Secondary outcomes were adverse symptoms possibly attributable to nitrofurantoin and bacterial resistance to nitrofurantoin. A sample size of 154 would detect a decrease in urinary tract infection incidence from 33% to 13%, with 80% power, two-sided alpha of 0.05, and allow 10% dropout.

Results: Of 154 participants randomized from September 2016 to May 2018, 151 were eligible for analysis: 75 received nitrofurantoin, and 76 received placebo. Demographics were similar between groups. The indication for surgery was prolapse (46%), incontinence (20%), or a combination (34%). Participants were discharged with an indwelling catheter (58%) or performing self-catheterization (42%). Median duration of catheter use was 4 days (interquartile range 3-7). Thirteen women in the nitrofurantoin group and 13 women in the placebo group experienced urinary tract infection (17.3% vs 17.1%, P=.97, relative risk [RR] [95% CI] 1.01 [0.50-2.04]). Adverse symptoms possibly attributable to nitrofurantoin were common in both groups (68% vs 61%, P=.34, RR [95% CI] 1.12 [0.88-1.43]). Resistance to nitrofurantoin was identified in seven urine cultures, four among nitrofurantoin and three among placebo recipients. In total, 52 urine cultures were obtained to evaluate symptoms of urinary tract infection, and only 27 of 52 grew at least 1,000 cfu/mL of uropathogenic bacteria.

Conclusion: Daily nitrofurantoin did not reduce the incidence of culture-proven urinary tract infection among women with catheter-managed urinary retention after pelvic reconstructive surgery. Culture confirmed urinary tract infection in only half of symptomatic episodes.

Clinical Trial Registration: ClinicalTrials.gov, NCT02727322.
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http://dx.doi.org/10.1097/AOG.0000000000003462DOI Listing
October 2019
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