Publications by authors named "Holly E Richter"

300 Publications

Accidental Bowel Leakage/Fecal Incontinence: Evidence-Based Management.

Obstet Gynecol Clin North Am 2021 Sep;48(3):467-485

Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA.

Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.
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http://dx.doi.org/10.1016/j.ogc.2021.05.003DOI Listing
September 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

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

Editorial Comment.

J Urol 2021 09 16;206(3):687. Epub 2021 Jun 16.

Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.

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http://dx.doi.org/10.1097/JU.0000000000001822.01DOI Listing
September 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

Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design.

Contemp Clin Trials 2021 06 16;105:106406. Epub 2021 Apr 16.

University of Alabama at Birmingham School of Medicine, Department of Obstetrics and Gynecology, Birmingham, AL, United States of America.

Objective: To compare the efficacy of an Intravaginal Motion-Based Digital Health System (PDHS) compared to standardized Pelvic Floor Muscle Training (PFMT) for the treatment of stress or stress-predominant urinary incontinence (SUI).

Methods: This is a virtually conducted prospective randomized controlled trial. The primary outcomes are change in urinary incontinence episodes by 3-day bladder diary and change in Urogenital Distress Inventory-6 score, measured at 8 weeks. Secondary outcomes include: Patient Global Impression of Severity (PGI-S), PGI-Improvement (PGI-I), Pelvic Floor Distress Inventory-20(PFDI-20), Pelvic Floor Impact Questionnaire-7(PFIQ-7), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-IR), Short Form-2 (SF-20), and assessment of adverse event (AE). Subjects are randomized 1:1 to an intervention group using leva PDHS for PFMT or a control group, using a home Kegel exercise program. Sample size needed to identify a 60% difference in incontinence episodes from baseline to 8 weeks post-randomization using alpha = 0.05, and a power of 0.8 is 156 subjects. To identify a 30% difference in the UDI-6 score from Baseline to Week 8 (alpha = 0.05, power = 0.8, using a one-tailed t-test) the needed sample size is 278, and allowing for an attrition rate of 15%, will require approximately 350 subjects, providing power to detect differences in both primary outcomes.

Results: Recruitment was initiated September 2020 and is on target to date. The trial is projected to be complete in 2021and is registered at clinicaltrials.govNCT04508153.

Conclusion: This novel virtual recruitment approach may provide more efficient recruitment of large numbers of subjects and provide input into the use of app-based management of pelvic floor interventions.
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http://dx.doi.org/10.1016/j.cct.2021.106406DOI Listing
June 2021

Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence.

Female Pelvic Med Reconstr Surg 2021 Mar 23. Epub 2021 Mar 23.

From the Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA Division of Female Pelvic Medicine and Reconstructive Surgery, Northwestern University, Feinberg School of Medicine, Chicago, IL Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City, OK Department of Urology, Cedars Sinai Medical Center, Los Angeles, CA Cleveland Clinic, Obstetrics, Gynecology, and Women's Health Institute, Cleveland, OH Department of Urology, Eastern Virginia Medical School, Norfolk, VA Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.

Objective: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI).

Methods: A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations.

Results: Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047).

Conclusions: In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.
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http://dx.doi.org/10.1097/SPV.0000000000001052DOI Listing
March 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

Association of Pelvic Organ Prolapse Quantification examination D point with uterosacral ligament suspension outcomes: the "OPTIMAL" D point.

Int Urogynecol J 2021 Aug 12;32(8):2179-2184. Epub 2021 Mar 12.

MedStar National Center for Advanced Pelvic Surgery, Georgetown University School of Medicine, Washington, DC, USA.

Introduction And Hypothesis: The objective was to determine the relationship between the preoperative D-point and apical outcomes at 24 months, using the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) dataset.

Methods: This was a secondary analysis of the OPTIMAL trial, a randomized multi-centered study comparing outcomes of sacrospinous ligament fixation and transvaginal uterosacral ligament suspension (USLS). The 2-year dataset utilized included women undergoing USLS with concomitant hysterectomy. The primary outcome was the relationship between preoperative D-point and apical outcomes at 24 months. Secondary objectives were to determine the relationship between preoperative D-point and anatomical, composite and subjective outcomes, and to determine a D-point cut-off that could be used to predict success in each of these categories.

Results: Of the 186 women in the USLS arm, 120 were available for analysis of anatomical failure at 24 months. A higher preoperative D-point correlated with improved apical outcome (C-point) at 24 months (r = 0.34; p value = 0.0002). Using ROC curves, a moderate association was found between the preoperative D-point and apical and anatomical success, (AUC 0.689 and 0.662). There was no relationship between preoperative D-point and composite or subjective success (AUC 0.577 and 0.458). Based on the ROC curves, a "cut-off" D-point value of -4.25 cm (sensitivity = 0.58, specificity = 0.67) was determined to be a predictor of postoperative anatomical success at 2 years.

Conclusions: Preoperative D-point correlates with postoperative anatomical and apical support, but is less successful at predicting subjective outcomes. The strongest predictive D-point cut-off for anatomical and apical success at 24 months was -4.25 cm.
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http://dx.doi.org/10.1007/s00192-021-04687-0DOI Listing
August 2021

Timing and Success of Postoperative Voiding Trial After Colpocleisis With and Without Concomitant Midurethral Sling.

Female Pelvic Med Reconstr Surg 2021 08;27(8):e608-e613

From the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology.

Objective: The aim of this study was to compare failure rates of first voiding trial (VT) within 7 days and on postoperative day (POD) 1 after colpocleisis with versus without concomitant midurethral sling (MUS). Predictors of POD 1 VT failure were also examined.

Methods: This was a retrospective cohort study of women undergoing colpocleisis from January 2012 to October 2019 comparing VT outcomes with versus without MUS. Primary outcome was first VT failure within 7 days; outcomes of VTs performed on POD 1 were also assessed. Association between MUS and VT failure and predictors of POD 1 VT failure were assessed via logistic regression.

Results: Of 119 women, 45.4% had concomitant MUS. First VT was performed on mean POD 3.1 ± 2.2 in the MUS group versus POD 1.8 ± 1.8 in the no MUS group (P < 0.01). The MUS group was less likely to undergo POD 1 VT (50% vs 83%, P < 0.01). Failure of the first VT did not differ (22.2% with MUS vs 32.8% without MUS, P = 0.20); no association between VT failure and MUS was noted (adjusted odds ratio [aOR], 0.6; 95% confidence interval [CI], 0.18-2.1). There were 68.1% (81/119) of participants who underwent POD 1 VT, MUS was performed in 33.3% (27/81). The POD 1 failure did not differ between those with 33.3% versus 40.7% without MUS (P = 0.52). Midurethral sling was not associated with POD 1 VT failure (aOR, 0.93; 95% CI, 0.27-3.23). In women undergoing POD 1 VT, preoperative postvoid residual was associated with VT failure (aOR, 1.39; 95% CI, 1.01-1.92).

Conclusions: In women undergoing colpocleisis, MUS was not associated with VT failure within 7 days or on POD 1. Increased preoperative postvoid residual was associated with POD 1 VT failure.
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http://dx.doi.org/10.1097/SPV.0000000000000996DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203756PMC
August 2021

Physical performance measures in older women with urinary incontinence: pelvic floor disorder or geriatric syndrome?

Int Urogynecol J 2021 02 17;32(2):305-315. Epub 2020 Nov 17.

Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.

Introduction And Hypothesis: To evaluate physical performance measures of mobility and functional impairments and assess their association with urinary incontinence (UI) severity and impact on quality of life among older women with UI.

Methods: In a cross-sectional pilot study, 20 women aged ≥ 70 years with UI completed UI questionnaires (Global Impression of Severity, Incontinence Impact Questionnaire [IIQ-7]) and functional status evaluation. Functional status evaluation included the Modified Physical Performance Test (MPPT; range 0-36), Short Physical Performance Battery (SPPB; range 0-12), and other physical performance measures (e.g., Timed Up and Go [TUG]). MPPT and SPPB scores < 32 and < 10, respectively, indicated impaired mobility and function. Descriptive statistics and Spearman correlation coefficients evaluated study variables and associations between UI and physical performance measures.

Results: Women were 76.6 ± 4.7 years old with mean body mass index 33.5 ± 9.0 kg/m. Mixed UI was the most prevalent (n = 17; 85%), and 14 (70%) participants rated their UI as moderate or severe. Low MPPT (< 32) and SPPB (< 10) scores were present in 65% (n = 13) and 35% (n = 7) of participants, respectively. Lower MPPT score (r = -0.46; P = 0.04) and worse TUG performance (r = 0.50; P = 0.03) were associated with greater UI impact on quality of life based on IIQ-7. SPPB did not correlate (P > 0.05) with UI measures.

Conclusions: Mobility and functional impairments are common among older women with UI. Associations between MPPT score and TUG performance with UI impact on quality of life suggest these physical performance measures could be markers of mobility and functional impairments in future research on UI in older women.
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http://dx.doi.org/10.1007/s00192-020-04603-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856110PMC
February 2021

The impact of frailty in older women undergoing pelvic floor reconstructive surgery.

Menopause 2020 11 9;28(3):332-336. Epub 2020 Nov 9.

University of Alabama at Birmingham, Birmingham, AL.

Importance And Objective: Women ≥ 65 years old commonly undergo pelvic surgery but are often not screened for coexisting frailty, the presence of which increases the risk of postoperative complications. In the absence of a current consensus, the objective of this review is to discuss the incorporation of a frailty assessment into the work-up of women undergoing pelvic floor reconstructive surgery.

Methods: This is a review of the literature, focusing on measurements of frailty including the Edmonton Frail Scale, FRAIL scale, Groningen Frailty Indicator, frailty phenotype, Tilburg Frailty Indicator, a 70-item frailty index, Mini-Cog score, Charlson comorbidity index, timed up and go test, and life-space assessment. Their use in the perioperative management of older women undergoing pelvic floor reconstructive surgery will be discussed.

Discussion And Conclusion: Understanding the concept of frailty and how it may affect surgical decisions and outcomes is essential. The timed up and go test, life space assessment and Mini-Cog assessment at a minimum should be considered preoperatively in patients over the age of 65 years old planning pelvic floor or elective surgery.
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http://dx.doi.org/10.1097/GME.0000000000001681DOI Listing
November 2020

Characterization of symptom severity and impact on four fecal incontinence phenotypes in women presenting for evaluation.

Neurourol Urodyn 2021 01 20;40(1):237-244. Epub 2020 Oct 20.

Division of Urogynecology and Pelvic Reconstructive Surgery, Department Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Aim: To characterize symptom-specific distress and impact on quality of life (QOL) among women with urge, passive, and combined urge/passive fecal incontinence (FI) phenotypes. A secondary aim was to characterize FI symptom-specific distress and impact on women with a novel fourth phenotype, stress FI.

Methods: Women with at least monthly FI from 2003 to 2017 were included. Participants completed the Modified Manchester Health Questionnaire (MMHQ) including MHQ and Fecal Incontinence Severity Index (FISI). Anorectal manometry (ARM) and endoanal ultrasound (EAUS) testing was performed. Total MHQ and FISI scores were compared across FI subtypes controlling for pertinent baseline covariates.

Results: The cohort included 404 subjects, 220 meeting criteria for urge FI, 67 passive FI, and 117 combined urge/passive FI. On MHQ, women with combined urge/passive FI were most impacted (p < 0.01). FISI scores were significantly different from combined urge/passive FI having the greatest impact (38.1 ± 12.5) and urge FI (31.1 ± 11.3), p < 0.01 having the least. No differences were observed in ARM measurements or anal sphincter defects among the three groups (all p > 0.05). Twenty-nine subjects were identified with stress FI. There were no differences in overall MHQ or FISI scores or anal sphincter evaluation among the urge, passive, and stress FI groups (all p > 0.05).

Conclusion: Women with combined urge/passive FI have higher symptom distress and impact on QOL than urge or passive FI alone. Further research is needed to determine the significance of stress FI as a subtype and response to treatment.
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http://dx.doi.org/10.1002/nau.24541DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7902383PMC
January 2021

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

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

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

Incontinence outcomes after "second primary" compared to repeat midurethral sling for recurrent and persistent stress urinary incontinence.

Int Urogynecol J 2021 Jan 25;32(1):75-80. Epub 2020 Jul 25.

Department of Obstetrics & Gynecology, Division of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.

Introduction And Hypothesis: The current study aims to assess the continence rate of a "second primary" midurethral sling (MUS) in women with recurrent/persistent stress urinary incontinence (SUI) after sling excision compared to a historical cohort who underwent a repeat MUS.

Methods: A retrospective cohort study of women who underwent excision of a primary MUS and placement of a "second primary" MUS from 2009 to 2016 compared to a historical cohort who underwent a repeat MUS from 2006 to 2009. The primary outcome was continence rate, defined as "not at all" or "somewhat" to Urogenital Distress Inventory (UDI-6) SUI subscale questions. Secondary outcomes included assessment of symptom severity (UDI-6), symptom-specific quality of life, Incontinence Impact Questionnaire (IIQ-7), Medical and Epidemiologic Aspects of Aging (MESA), and Patient Global Impression of Improvement (PGI-I).

Results: Survey responses were available for 23/64 (36%) in the "second primary" MUS group versus 88/135 (65%) in the historical cohort. Mean follow-up in months, second primary: 41.8 ± 26.1 versus repeat: 36.2 ± 14.1, p = 0.16 and age (years): 56.4 ± 10.7 versus 59.8 ± 10.8, p = 0.19. Continence rates were 48% in "second primary" versus 56% in the repeat group (p = 0.50). Both groups had significant improvement in questionnaire scores postoperatively with no intergroup differences. Multivariable analysis demonstrated that odds of success did not differ between groups (adjusted odds ratio: 0.73, 95% confidence interval: 0.27-1.99).

Conclusions: In women with recurrent/persistent SUI, repeat and "second primary" MUS procedures demonstrate similar success outcomes and improvement in UI symptom distress and QOL. Continued research is needed for this increasingly important clinical question.
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http://dx.doi.org/10.1007/s00192-020-04447-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7790899PMC
January 2021

Short-, mid-, and long-term incontinence outcomes in women undergoing mid-urethral sling procedures: a retrospective cohort study.

Int Urogynecol J 2021 Mar 20;32(3):609-614. Epub 2020 Jun 20.

Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama Birmingham, Birmingham, AL, USA.

Introduction And Hypothesis: The primary aim was to compare subjective treatment success among women in short-, mid-, and long-term follow-up after mid-urethral sling (MUS). Symptom severity, condition-specific quality of life (QOL), and patient satisfaction were also examined.

Methods: Women undergoing a primary MUS between 2001 and 2010 were identified by CPT code. Eligible subjects were mailed the Urogenital Distress Inventory (UDI-6), Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction Questionnaire (PSQ). Follow-up intervals were short term (≤ 36 months), mid term (37-70 months), and long term (119-200 months). The primary outcome of treatment success was defined as responses of "not at all" or "somewhat" to both stress urinary incontinence (SUI) subscales on the UDI-6.

Results: Of 896 respondents, 361 were assessed in the short-term (23.3 ± 7.2 months), 251 in the mid-term (49.8 ± 9.1 months), and 284 in the long-term group (147.9 ± 20.6 months). Treatment success was 75.4% in the short-, 62.3% in the mid-, and 67.0% in the long-term groups (p < 0.01). Logistic regression showed women with mid- and long-term follow-up were nearly half as likely as their short-term counterparts to report treatment success (adjusted odds ratio [aOR] 0.51, 95% confidence interval [CI] 0.36, 0.74). UDI-6 and PFIQ-7 scores differed significantly among the short-, mid- and long-term groups (p < 0.01). Patient satisfaction was similar, 83.3% in the short-, 76.6% in the mid-, and 78.2% in the long-term follow-up (p = 0.31).

Conclusion: Women with short-term follow-up had the highest subjective treatment success rates; mid- and long-term follow-up was lower, but sustained after 3 years. Symptom severity and impact on QOL were lowest in the short-term group. However, high satisfaction was noted across all groups.
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http://dx.doi.org/10.1007/s00192-020-04393-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749834PMC
March 2021

Effect of darifenacin on fecal incontinence in women with double incontinence.

Int Urogynecol J 2021 Sep 15;32(9):2357-2363. Epub 2020 Jun 15.

Division of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, 1700 6th Ave S.WIC Rm 10382, Birmingham, AL, 35233, USA.

Introduction And Hypothesis: To evaluate change in fecal incontinence symptom severity after 8 weeks of darifenacin therapy in patients with double incontinence-urgency urinary incontinence (UUI) and fecal incontinence. Important secondary outcomes included fecal incontinence symptom distress and impact on quality of life, fecal incontinence episodes, global impression of improvement and overactive bladder symptom distress and impact.

Methods: Prospective open-label cohort study of women presenting primarily with UUI, diagnosed with double incontinence and electing antimuscarinic therapy for UUI. Women ≥ 18 years with moderate or greater bothersome UUI and fecal incontinence of liquid/solid stool with St. Marks (Vaizey) score ≥ 12 were included. Subjects were treated with darifenacin 15 mg daily for 8 weeks. The primary outcome was change in fecal incontinence symptom severity using the St. Marks (Vaizey) score after 8 weeks. Sample size was based on the minimally important difference of the St. Marks, -5, and standard deviation, ± 8.5; 30 subjects provided 80% power and type I error of 0.05, including a 15% attrition rate.

Results: Thirty-two women were consented with mean baseline St. Marks (Vaizey) score of 18.0 ± 3.0. Mean age was 66.5 ± 10.3 years. Twenty-eight subjects (29/32, 87.5%) completed assessments. St. Marks (Vaizey) score significantly improved from 18.0 to 11.0 [mean difference - 7.0, 95% confidence interval (CI): -8.7, -5.3], and 19 subjects (19/32,67.9%) met the minimally important difference. Statistically significant improvements were also noted in fecal incontinence frequency, quality of life, and overactive bladder symptom bother and quality of life (all p < 0.01).

Conclusions: Darifenacin can be considered a highly effective early intervention in women suffering from double incontinence.

Clinical Trial Registration: Bladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.
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http://dx.doi.org/10.1007/s00192-020-04369-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736065PMC
September 2021

Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Recurrence of the Vagina using Estrogen: IMPROVE).

Female Pelvic Med Reconstr Surg 2021 01;27(1):e227-e233

Departments of Population and Data Sciences and Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX.

Objectives: To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair.

Methods: Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence.

Results: Recruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit.

Conclusions: This trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.
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http://dx.doi.org/10.1097/SPV.0000000000000899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769931PMC
January 2021

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

Pelvic floor disorder symptoms and bone strength in postmenopausal women.

Int Urogynecol J 2020 Sep 29;31(9):1777-1784. Epub 2020 Feb 29.

Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL, 35233, USA.

Introduction And Hypothesis: The current study is aimed at characterizing the association between pelvic floor disorder symptoms and bone strength reflecting a potential connective tissue pathophysiology in postmenopausal women.

Methods: A cross-sectional study was conducted in postmenopausal women undergoing osteoporosis evaluation from 2007 to 2010. Urinary incontinence (UI) was defined as urinary leakage ≥2-3 times/week. UI types were defined using the 3 Incontinence Questionnaire. Fecal incontinence was defined as stool leakage ≥1/month, and pelvic organ prolapse as a positive response to "Do you have a bulge or something falling out that you can see or feel in your vaginal area?" Bone quality and quantity were assessed using the trabecular bone score (TBS) and bone mineral density respectively: bone strength was defined by combined quality/quantity index, low strength being equivalent to moderate to severe fracture risk; low quality as TBS ≤ 1.31; low quantity by T-score <-1 or on osteoporosis medication.

Results: Of 681 subjects, 262 had low bone strength whereas 419 were normal using the combined quality/quantity bone assessment. Characteristics were similar except for age (low bone strength: 69.0 ± 8.2 vs normal: 65.0 ± 7.1, p < 0.01) and smoking (8.8% vs 3.3%, p < 0.01). Low bone strength was associated with any UI (adjusted odds ratio [aOR]: 1.48, 1.05-2.10), stress (aOR: 1.53, 1.06-2.21), and mixed (aOR :1.45, 1.02-2.05). Women with low bone quality had increased odds of UI (any, urgency, mixed), whereas none of the pelvic floor disorder symptoms was associated with low bone quantity.

Conclusions: Low bone strength defined by a combined quantity/quality index, as well as low bone quality alone, were associated with increased risk of UI.
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http://dx.doi.org/10.1007/s00192-020-04254-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429315PMC
September 2020

Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence.

Am J Gastroenterol 2020 01;115(1):115-127

RTI International, Research Triangle Park, North Carolina.

Objective: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI).

Methods: Women (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 × 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, ≥50% reduction in FI episodes, and combined St. Mark's MID and ≥50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence.

Results: Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score.

Discussion: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI.
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http://dx.doi.org/10.14309/ajg.0000000000000482DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197976PMC
January 2020

Self-management of accidental bowel leakage and interest in a supportive m-Health app among women.

Int Urogynecol J 2020 06 24;31(6):1133-1140. Epub 2019 Dec 24.

Department Obstetrics and Gynecology, Division of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.

Introduction: Self-management with clinician guidance is a cornerstone of successful conservative treatment for accidental bowel leakage (ABL). There are currently few resources to assist patients with that essential self-management. The purpose of this study was to describe self-management of ABL and explore interest in a mobile health application (m-Health app) for supporting ABL self-management among community-living women.

Methods: Using an observational/descriptive design, women (18+ years) previously seen in a urogynecology clinic for ABL were mailed a survey containing eight multiple-choice questions and an open-ended prompt for comments.

Results: Survey responses were received from 161 women (18% response rate). The highest percentage of participants was aged 61-70 years (39%). Nearly half of the participants (47%) "did not know anything" about ABL self-management before visiting a clinician. Only 4% "knew a lot." Of those who have been trying to self-manage their ABL (n = 132), 37% reported that it was not effective, and only 5% thought their self-management was "very effective." Half (50%) of the participants had "a lot of" interest in an m-Health app to support managing ABL, and 30% had "some" interest. The vast majority (89%) thought that it was "very important" to have ongoing guidance and support for self-managing ABL.

Conclusions: Before visiting a clinician, most women with ABL lacked knowledge about ABL self-management, and their self-management was not very effective. Women thought having guidance to self-manage ABL was important. There would be good interest among women in an m-Health app supporting self-management of ABL if one were created.
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http://dx.doi.org/10.1007/s00192-019-04192-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7500862PMC
June 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

Assessing patients' preferences for gender, age, and experience of their urogynecologic provider.

Int Urogynecol J 2020 06 11;31(6):1203-1208. Epub 2019 Dec 11.

Department of Obstetrics and Gynecology, Division of Urogynecology and Pelvic, Reconstructive Surgery, University of Alabama at Birmingham, WIC Suite 10382, 619 19th Street South, 176F, Birmingham, AL, 35249-7333, USA.

Introduction And Hypothesis: Understanding patient preferences regarding provider characteristics is an under-explored area in urogynecology. This study aims to describe patient preferences for urogynecologic care, including provider gender, age, experience, and presence of medical trainees.

Methods: This was a multicenter, cross-sectional, survey-based study assessing patient preferences with a voluntary, self-administered, anonymous questionnaire prior to their first urogynecology consult. A 5-point Likert scale addressing provider gender, age, experience, and presence of trainees was used. Descriptive statistics summarized patient characteristics and provider preferences. Chi-squared (or Fisher's exact) test was used to test for associations.

Results: Six hundred fifteen women participated from eight sites including all geographic regions across the US; 70.8% identified as white with mean age of 58.5 ± 14.2 years. Urinary incontinence was the most commonly reported symptom (45.9%); 51.4% saw a female provider. The majority of patients saw a provider 45-60 years old (42.8%) with > 15 years' experience (60.9%). Sixty-five percent of patients preferred a female provider; 10% preferred a male provider. Sixteen percent preferred a provider < 45 years old, 36% preferred 45-60 years old, and 11% of patients preferred a provider > 60 years old. Most patients preferred a provider with 5-15 or > 15 years' experience (49% and 46%, respectively). Eleven percent preferred the presence of trainees while 24% preferred trainee absence.

Conclusion: Patient preferences regarding urogynecologic providers included female gender and provider age 45-60 years old with > 5 years' experience. Further study is needed to identify qualitative components associated with these preferences.
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http://dx.doi.org/10.1007/s00192-019-04189-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7274874PMC
June 2020
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