Publications by authors named "Aino Fianu-Jonasson"

32 Publications

A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies.

Adv Urol 2021 15;2021:8822186. Epub 2021 Feb 15.

Invent Medic Sweden AB, Medicon Village, 223 81, Lund, Sweden.

A multicenter, randomized, controlled clinical trial and four postmarket user acceptance investigations were carried out to document the safety, performance, and user acceptance of Efemia Bladder Support, a novel vaginal inlay for the temporary reduction of stress urinary incontinence (SUI). The clinical investigation enrolled 97 women diagnosed with SUI, randomized 3 : 1 to either treatment or standard care (control). The primary endpoint was reduction of urine leakage, measured as change in pad weight baseline week compared with treatment week. Secondary endpoints were treatment success, calculated as the percentage of subjects with >70% reduction in pad weight, reduction in incontinence episodes, and quality of life (QoL). 75 women (77%) completed the clinical investigation. No serious adverse events occurred. The treatment group reached a 55% ( < 0.001) mean reduction of total leakage compared to the control arm. A subanalysis, involving only leakage during provocation testing (coughing and jumping), showed a 67% ( < 0.001) mean reduction of leakage. No significant effect on QoL could be observed. 51% of the women answered "yes" to the question if they would use the device to reduce SUI. The user acceptance of the device was further investigated in four postmarket studies, using an improved device design with a slimmer centerpiece and a thinner handle, while keeping the effect achieving parts of the device unchanged. An average of 74% of the 102 participants in the postmarket studies reported that they were likely to continue using Efemia. The highest user satisfaction was seen in the two studies evaluating the use of Efemia during exercise, where 83% and 88% of the women were likely to continue using Efemia. It can be concluded that Efemia is a safe, well-tolerated, and effective alternative for reducing SUI, both in everyday life and during physical exercise.
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http://dx.doi.org/10.1155/2021/8822186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899758PMC
February 2021

Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study.

Med Devices (Auckl) 2020 5;13:339-347. Epub 2020 Oct 5.

StatCons, Malmo, Sweden.

Purpose: The primary objective was to compare the efficacy of 12 weeks of daily treatment with Aqueous Hypromellose-based vaginal (Vagivital) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel in reducing the severity of the most bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity) observed at baseline. The secondary objectives were to evaluate the other vulvovaginal atrophy symptoms, vaginal pH, superficial squamous cells, and the safety and tolerability of both gels.

Patients And Methods: This double-blind, randomized study evaluated the safety and efficacy of subjects randomly assigned to 12 weeks of daily intravaginal oxytocin gel (n=79) or Aqueous Hypromellose-based vaginal gel (n=78). The efficacy evaluation was performed using data from all included subjects who fulfilled entry criteria.

Results: Both treatments induced statistically significant reductions in the severity of the MBS from baseline until 4 weeks (Vagivital mean reduction 0.90, p=0.0000; Oxytocin mean reduction 0.82, p=0.0000) and 12 weeks post baseline (Vagivital mean reduction 1.28, p=0.0000; Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point. No serious adverse events were reported in the Aqueous Hypromellose-based vaginal gel group during the treatment period, but one (breast cancer) was reported in the oxytocin gel group (assessed as unlikely related to the study compound).

Conclusion: Significant reductions in the severity of the MBS were seen in both the Aqueous Hypromellose-based vaginal gel and the oxytocin gel groups, but with no significant differences in severity reduction seen between the groups. Both gels were safe and well tolerated. Given the benefits of avoiding the use of hormones, Aqueous Hypromellose-based vaginal gel is an attractive first choice in the treatment of postmenopausal women with vulvovaginal atrophy symptoms.
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http://dx.doi.org/10.2147/MDER.S265824DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547122PMC
October 2020

Clinical validation of a novel automated cell-free DNA screening assay for trisomies 21, 13, and 18 in maternal plasma.

Prenat Diagn 2019 10 19;39(11):1011-1015. Epub 2019 Aug 19.

Division of Obstetrics and Gynecolocy, Department of Clinical Science Huddinge, Karolinska Institute, Solna, Sweden.

Objective: To evaluate clinical performance of a new automated cell-free (cf)DNA assay in maternal plasma screening for trisomies 21, 18, and 13, and to determine fetal sex.

Method: Maternal plasma samples from 1200 singleton pregnancies were analyzed with a new non-sequencing cfDNA method, which is based on imaging and counting specific chromosome targets. Reference outcomes were determined by either cytogenetic testing, of amniotic fluid or chorionic villi, or clinical examination of neonates.

Results: The samples examined included 158 fetal aneuploidies. Sensitivity was 100% (112/112) for trisomy 21, 89% (32/36) for trisomy 18, and 100% (10/10) for trisomy 13. The respective specificities were 100%, 99.5%, and 99.9%. There were five first pass failures (0.4%), all in unaffected pregnancies. Sex classification was performed on 979 of the samples and 99.6% (975/979) provided a concordant result.

Conclusion: The new automated cfDNA assay has high sensitivity and specificity for trisomies 21, 18, and 13 and accurate classification of fetal sex, while maintaining a low failure rate. The study demonstrated that cfDNA testing can be simplified and automated to reduce cost and thereby enabling wider population-based screening.
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http://dx.doi.org/10.1002/pd.5528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899636PMC
October 2019

Correction to: Defined serum- and xeno-free cryopreservation of mesenchymal stem cells.

Cell Tissue Bank 2019 06;20(2):329-330

Division of Obstetrics and Gynecology, K57, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Huddinge, 141 86, Stockholm, Sweden.

In the original article, Fig. 1A was by mistakenly duplicated. The corrected image is provided in this correction article.
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http://dx.doi.org/10.1007/s10561-019-09752-zDOI Listing
June 2019

Imaging single DNA molecules for high precision NIPT.

Sci Rep 2018 03 14;8(1):4549. Epub 2018 Mar 14.

Vanadis Diagnostics, a PerkinElmer company, Stockholms Lan, Sweden.

Cell-free DNA analysis is becoming adopted for first line aneuploidy screening, however for most healthcare programs, cost and workflow complexity is limiting adoption of the test. We report a novel cost effective method, the Vanadis NIPT assay, designed for high precision digitally-enabled measurement of chromosomal aneuploidies in maternal plasma. Reducing NIPT assay complexity is achieved by using novel molecular probe technology that specifically label target chromosomes combined with a new readout format using a nanofilter to enrich single molecules for imaging and counting without DNA amplification, microarrays or sequencing. The primary objective of this study was to assess the Vanadis NIPT assay with respect to analytical precision and clinical feasibility. Analysis of reference DNA samples indicate that samples which are challenging to analyze with low fetal-fraction can be readily detected with a limit of detection determined at <2% fetal-fraction. In total of 286 clinical samples were analysed and 30 out of 30 pregnancies affected by trisomy 21 were classified correctly. This method has the potential to make cost effective NIPT more widely available with more women benefiting from superior detection and false positive rates.
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http://dx.doi.org/10.1038/s41598-018-22606-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5852104PMC
March 2018

Treatment of premenstrual dysphoric disorder with the GABA receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial.

Psychoneuroendocrinology 2017 Jun 1;80:46-55. Epub 2017 Mar 1.

Department of Clinical Science, Umeå University, SE-901 85 Umeå, Sweden.

Context: Allopregnanolone is a metabolite from progesterone and a positive modulator of the GABA receptor. This endogenous steroid may induce negative mood in sensitive women when present in serum levels comparable to the premenstrual phase. Its endogenous isomer, isoallopregnanolone, has been shown to antagonize allopregnanolone effects in experimental animal and human models.

Objective: The objective was to test whether inhibition of allopregnanolone by treatment with the GABA modulating steroid antagonist (GAMSA) Sepranolone (UC1010) during the premenstrual phase could reduce symptoms of the premenstrual dysphoric disorder (PMDD). The pharmacokinetic parameters of UC1010 when given as a subcutaneous injection were measured in healthy women prior to the study in women with PMDD.

Design: This was an explorative randomized, double-blind, placebo-controlled study.

Setting: Swedish multicentre study with 10 centers.

Participants: Participants were 26 healthy women in a pharmacokinetic phase I study part, and 126 women with PMDD in a phase II study part. Diagnosis followed the criteria for PMDD in DSM-5 using Daily Record of Severity of Problems (DRSP) and Endicott's algorithm.

Intervention: Subjects were randomized to treatment with UC1010 (10 or 16mg) subcutaneously every second day during the luteal phase or placebo during one menstrual cycle.

Outcome Measures: The primary outcome measure was the sum of all 21 items in DRSP (Total DRSP score). Secondary outcomes were Negative mood score i.e. the ratings of the 4 key symptoms in PMDD (anger/irritability, depression, anxiety and lability) and impairment (impact on daily life).

Results: 26 healthy women completed the pharmacokinetic phase I study and the dosing in the following trial was adjusted according to the results. 106 of the 126 women completed the phase II study. Within this group, a significant treatment effect with UC1010 compared to placebo was obtained for the Total DRSP score (p=0.041) and borderline significance (p=0.051) for the sum of Negative mood score. Nineteen participants however showed symptoms during the follicular phase that might be signs of an underlying other conditions, and 27 participants had not received the medication as intended during the symptomatic phase. Hence, to secure that the significant result described above was not due to chance, a post hoc sub-group analysis was performed, including only women with pure PMDD who completed the trial as intended (n=60). In this group UC1010 reduced Total DRSP scores by 75% compared with 47% following placebo; the effect size 0.7 (p=0.006), and for sum of Negative mood score (p=0.003) and impairment (p=0.010) with the effect size 0.6. No severe adverse events were reported during the treatment and safety parameters (vital signs and blood chemistry) remained normal during the study.

Conclusions: This explorative study indicates promising results for UC1010 as a potential treatment for PMDD. The effect size was comparable to that of SSRIs and drospirenone containing oral contraceptives. UC1010 was well tolerated and deemed safe.
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http://dx.doi.org/10.1016/j.psyneuen.2017.02.031DOI Listing
June 2017

Annual direct and indirect costs attributable to nocturia in Germany, Sweden, and the UK.

Eur J Health Econ 2017 Jul 27;18(6):761-771. Epub 2016 Sep 27.

Catalyst Health Economics Consultants, 34b High Street, Northwood, Middlesex, HA6 1BN, UK.

Objective: Our aim was to estimate the prevalence-based cost of illness imposed by nocturia (≥2 nocturnal voids per night) in Germany, Sweden, and the UK in an average year.

Methods: Information obtained from a systematic review of published literature and clinicians was used to construct an algorithm depicting the management of nocturia in these three countries. This enabled an estimation of (1) annual levels of healthcare resource use, (2) annual cost of healthcare resource use, and (3) annual societal cost arising from presenteeism and absenteeism attributable to nocturia in each country.

Results: In an average year, there are an estimated 12.5, 1.2, and 8.6 million patients ≥20 years of age with nocturia in Germany, Sweden, and the UK, respectively. In an average year in each country, respectively, these patients were estimated to have 13.8, 1.4, and 10.0 million visits to a family practitioner or specialist, ~91,000, 9000, and 63,000 hospital admissions attributable to nocturia and 216,000, 19,000, and 130,000 subjects were estimated to incur a fracture resulting from nocturia. The annual direct cost of healthcare resource use attributable to managing nocturia was estimated to be approximately €2.32 billion in Germany, 5.11 billion kr (€0.54 billion) in Sweden, and £1.35 billion (€1.77 billion) in the UK. The annual indirect societal cost arising from both presenteeism and absenteeism was estimated to be approximately €20.76 billion in Germany and 19.65 billion kr (€2.10 billion) in Sweden. In addition, in the UK, the annual indirect cost due to absenteeism was an estimated £4.32 billion (€5.64 billion).

Conclusions: Nocturia appears to impose a substantial socioeconomic burden in all three countries. Clinical and economic benefits could accrue from an increased awareness of the impact that nocturia imposes on patients, health services, and society as a whole.
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http://dx.doi.org/10.1007/s10198-016-0826-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486451PMC
July 2017

Mirabegron as Add-On Treatment to Solifenacin in Patients with Incontinent Overactive Bladder and an Inadequate Response to Solifenacin Monotherapy: Responder Analyses and Patient-Reported Outcomes from the BESIDE Study [corrected].

J Urol 2016 09 8;196(3):809-18. Epub 2016 Apr 8.

University of Bristol and Bristol Urological Institute, Bristol, United Kingdom.

Purpose: We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron 50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg.

Materials And Methods: Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were randomized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg, or solifenacin 5 or 10 mg for 12 weeks. The mirabegron dose was increased from 25 to 50 mg after week 4. Symptom bother, health related quality of life and patient perception of bladder condition were assessed by OAB-q (Overactive Bladder Questionnaire) and the PPBC (Patient Perception of Bladder Condition) questionnaire, respectively. Responder rates were based on a 50% reduction in daily incontinence, zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC.

Results: Overall 2,174 patients with a median age of 59 years were randomized, including 727 to the combination, 728 to solifenacin 5 mg and 719 to solifenacin 10 mg. Symptom bother, total health related quality of life and its subscales (coping, concern and social), and PPBC were significantly improved with combination vs solifenacin monotherapy (p <0.05). The odds of achieving clinically meaningful improvements in incontinence, micturition frequency, symptom bother, health related quality of life and PPBC were significantly higher for combination than solifenacin monotherapy. The odds of becoming continent was 47% and 28% higher for combination vs solifenacin 5 and 10 mg (OR 1.47, 95% CI 1.17-1.84, p = 0.001 and OR 1.28; 95% CI 1.02-1.61, p = 0.033, respectively).

Conclusions: Significantly more patients on the combination achieved clinically meaningful improvements in incontinence and micturition frequency. Improvements were accompanied by similar improvements in PPBC, symptom bother and health related quality of life.
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http://dx.doi.org/10.1016/j.juro.2016.03.174DOI Listing
September 2016

Oxytocin improves cytological and histological profiles of vaginal atrophy in postmenopausal women.

Post Reprod Health 2016 Mar 15;22(1):25-33. Epub 2016 Feb 15.

Department of Animal Environment and Health, Swedish University of Agricultural Sciences, Skara, Sweden School of Life Science, University of Skövde, Skövde, Sweden.

Objective: To investigate if topical oxytocin can reverse vaginal atrophy, as assessed by cytological and histological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.

Study Design: Sixty-eight postmenopausal women diagnosed with vaginal atrophy were randomized for this multicenter, double-blinded, placebo-controlled trial. Thirty-three women received 600 IU vagitocin, an oxytocin containing gel, and 35 women received a placebo gel intravaginally. The dose was 600 IU daily for the first two weeks and thereafter 600 IU twice a week for 10 weeks. All participant women underwent four visits and a subgroup of 20 women had a further fifth visit. Vaginal smears for cytological evaluation were collected at all visits. Vaginal biopsies were taken in 20 women before and after 12 weeks of treatment for histological analysis. In these women a vaginal smear was also collected after 14 weeks.

Results: The increase in the percentage of superficial cells between 0 and 2 weeks was significantly greater after treatment with vagitocin in comparison with placebo (p = 0.04). The difference in the maturation value between 0 and 12 weeks was significantly higher in the vagitocin than in the placebo group (p = 0.01). The reduction in the scores of atrophy was according to the histological investigation significantly greater in the vagitocin group than in the placebo group at 12 weeks (p < 0.04).

Conclusion: Daily intravaginal treatment with vagitocin 600 IU improves expressions of vaginal atrophy as recorded by cytological investigation of vaginal smears and histological analysis of vaginal biopsies. Treatment twice weekly seems to be less effective regarding the increase in superficial cells.
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http://dx.doi.org/10.1177/2053369116629042DOI Listing
March 2016

Defined serum- and xeno-free cryopreservation of mesenchymal stem cells.

Cell Tissue Bank 2015 Jun 13;16(2):181-93. Epub 2014 Aug 13.

Division of Obstetrics and Gynecology, K57, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Huddinge, 141 86, Stockholm, Sweden,

Mesenchymal stem cells (MSCs) have vast potential in cell therapy, and are experimentally used in the clinic. Therefore, it is critical to find a serum- and xeno-free cryopreservation method. The aim of this study was to compare two serum- and xeno-free cryoprotectants for MSCs. Adipose tissue MSCs (Ad-MSCs) and bone marrow MSCs (BM-MSCs) were cryopreserved in two cryoprotectants: the defined serum- and xeno-free STEM-CELLBANKER™ (CB) and 10 % dimethyl sulfoxide (DMSO) in a xeno-free serum replacement cell culture medium and compared to non-cryopreserved MSCs. MSCs cryopreserved in CB or DMSO had similar morphology and surface marker expression compared to their respective non-cryopreserved MSC. Ad-MSCs and BM-MSC in both cryoprotectant media exhibited reduced mean fluorescence intensity (MFI) for CD105, BM-MSCs for CD73 and Ad-MSC increased MFI for HLA class I compared to non-cryopreserved MSCs. Population doubling time of CB cryopreserved and non-cryopreserved Ad-MSCs was similar (38.1 ± 13.6 and 36.8 ± 12.1 h), but somewhat higher when cryopreserved in DMSO (42.2 ± 10.8 h). BM-MSCs had higher population doubling time (CB 47.7 ± 11.4 and DMSO 62.3 ± 32.9 h respectively, p < 0.05) compared to Ad-MSCs. The viability of Ad-MSCs was significantly higher after cryopreservation in CB compared to DMSO (90.4 ± 4.5 % vs. 79.9 ± 3.8 % respectively). Ad-MSCs and BM-MSCs retained their mesodermal differentiation potential when cryopreserved in both cryoprotectants. The characteristics of Ad-MSCs post-thawing are better preserved by CB than by DMSO in serum- and xeno-free medium. Furthermore, Ad-MSCs and BM-MSCs are differently affected by the cryoprotectants, which may have implications for cell therapy.
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http://dx.doi.org/10.1007/s10561-014-9463-8DOI Listing
June 2015

Defined serum-free media for in vitro expansion of adipose-derived mesenchymal stem cells.

Cytotherapy 2014 Jul 13;16(7):915-26. Epub 2014 Apr 13.

Division of Obstetrics and Gynecology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden; Center for Hematology and Regenerative Medicine, Karolinska Institutet, Stockholm, Sweden.

Background: There is a growing interest in mesenchymal stem cells (MSCs) because they are regarded as good candidates for cell therapy. Adipose tissue represents an easily accessible source to derive mesenchymal stem cells (Ad-MSCs) non-invasively in large numbers. The aim of this study was to evaluate a defined serum-free medium for in vitro expansion of MSCs as a prerequisite for their clinical use.

Methods: Adipose tissue was isolated from healthy donors. Cells were isolated and expanded for five passages in serum-free medium (Mesencult-XF) and Dulbecco's modified Eagle's medium supplemented with 10% fetal bovine serum (DMEM-FBS). MSC morphology, marker expression, viability, population doubling time and differentiation potential toward osteogenic and adipogenic lineages were evaluated. Bone marrow MSCs were included as controls.

Results: Ad-MSCs cultured in Mesencult-XF had shorter population doubling time (33.3 ± 13.7 h) compared with those cultured in DMEM-FBS (54.3 ± 41.0 h, P < 0.05). Ad-MSCs cultured in Mesencult-XF displayed a stable morphology and surface marker expression and a higher differentiation potential in comparison to Ad-MSCs cultured in DMEM-FBS.

Conclusions: The defined serum-free and xeno-free Mesencult-XF media appear to be a good choice for Ad-MSCs, but it is not as good in supporting culture of bone marrow MSCs when the cells are to be used for clinical purposes.
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http://dx.doi.org/10.1016/j.jcyt.2014.02.006DOI Listing
July 2014

European content validation of the Self-Assessment Goal Achievement (SAGA) questionnaire in patients with overactive bladder.

Int Urogynecol J 2013 Sep 9;24(9):1529-36. Epub 2013 Apr 9.

Department of Urogynecology, St. Mary's Hospital, Imperial College, Cambridge Wing, Praed Street, London, W2 1NY, UK.

Introduction And Hypothesis: The Self-Assessment Goal Achievement (SAGA) questionnaire is a patient-completed instrument designed to assess goal attainment in the behavioral or pharmacologic treatment of lower urinary tract symptoms (LUTS), including overactive bladder (OAB). The SAGA questionnaire allows patients to identify and rank the importance of treatment goals before treatment is initiated; the follow-up SAGA questionnaire quantifies the achievement of these patient-identified goals. The objective of this qualitative research was to confirm the content validity of the German, Spanish, Swedish, and English (UK) language versions of the SAGA questionnaire in patients with OAB with or without other LUTS.

Methods: The SAGA questionnaire was translated to each language in accordance with a well-established forward and backward harmonization method. Patient interviews were then conducted according to a cognitive debriefing methodology. Qualitative analysis of patients' input allowed assessment of content validity of each linguistically adapted SAGA questionnaire.

Results: All patients (n = 29; six to eight per targeted country) found the SAGA questionnaire easy to understand and to complete. Most patients completed the nine prespecified (fixed) treatment goals and were able to add up to five personal goals in the open-ended portion and rate each goal by importance. Differences were identified in how the various languages communicated some of the concepts assessed with the SAGA questionnaire. Rewording of the translated versions of the questionnaire was necessary in some cases.

Conclusions: This linguistic content validation study in four European languages indicates that SAGA is a comprehensive, easy-to-understand, and relevant questionnaire for patient-completed evaluation of LUTS/OAB symptoms and treatment goal attainment.
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http://dx.doi.org/10.1007/s00192-012-2039-xDOI Listing
September 2013

Clinical value of a patient-reported goal-attainment measure: the global development of self-assessment goal achievement (SAGA) questionnaire for patients with lower urinary tract symptoms.

Neurourol Urodyn 2014 Jan 19;33(1):90-4. Epub 2013 Feb 19.

St Mary's Hospital, Imperial College, London, United Kingdom.

Aims: To discuss the importance of patients' treatment goals and perceived goal attainment to better address expectations in the treatment of lower urinary tract symptoms (LUTS), including overactive bladder (OAB).

Methods: The development of the Self-Assessment Goal Achievement (SAGA) questionnaire was driven by measurement principles from the field of qualitative and psychometric research adapted to elicit patients' treatment goals. At baseline, SAGA solicits individualized responses of patient's treatment expectations and goals, and at follow-up SAGA uses a goal-attainment scale (GAS) to document goal achievement.

Results: The SAGA questionnaire provides a basis for the patient and physician to discuss realistic treatment expectations and to measure the alignment between patients' expectations and treatment outcomes in terms of improvement in symptoms and impact on function. Therefore, incorporating the SAGA questionnaire into clinical trials may provide an additional dimension of treatment efficacy by incorporating data on treatment satisfaction from the patient's perspective.

Conclusions: The SAGA questionnaire is a useful tool for patient-centered discussions about the treatment and management of LUTS, including OAB, and assisting physicians in tracking progress and managing patient expectations during therapy.
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http://dx.doi.org/10.1002/nau.22377DOI Listing
January 2014

Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study.

Menopause Int 2011 Dec 25;17(4):120-5. Epub 2011 Nov 25.

Department of Obstetrics and Gynecology, Huddinge Hospital, Karolinska Institutet, Stockholm, Sweden.

Introduction: Oxytocin is a peptide hormone produced in the hypothalamus and it is best known for its role in labour and lactation. This double-blind, randomized study was performed at Huddinge Hospital of Karolinska Institutet, Stockholm in order to test the effectiveness of topical oxytocin gel in women with postmenopausal vaginal atrophy.

Methods: Twenty postmenopausal women (at least two years after menopause) with symptoms of vaginal atrophy such as vaginal dryness, pain, itching, discomfort and bleeding during intercourse were enrolled in the study when visual inspection of the vagina had confirmed that their mucosa was atrophic. The participants were randomized to intravaginal treatment with either oxytocin or placebo gel for seven days. Before and after treatment, a gynaecological examination and a visual and colposcopic inspection of the vagina were performed, biopsies from the vaginal mucosa were taken and blood samples were collected for analysis of circulating levels of estradiol and oxytocin.

Results: Prior to treatment, visual and colposcopic inspection showed that all of the 20 participants had an atrophic vaginal mucosa. After treatment with the oxytocin gel, the examination showed that the vaginal epithelium of seven of the 10 participants in the oxytocin group had become healthier and normalized. No change in these parameters was observed among the 10 participants in the placebo group. This difference between the oxytocin and placebo groups was significant (P= 0.003). Seven participants in the active group and four in the placebo group reported relief of symptoms of vaginal atrophy after seven days of applying the gel. The effect of oxytocin to normalize the morphological appearance of the vaginal mucosa was almost significant when compared with the placebo group (P= 0.07). There was no significant difference between the circulating levels of estradiol and oxytocin in both the oxytocin and placebo groups before and after treatment. None of the participants reported any side-effects.

Conclusion: Topical treatment with oxytocin appears to improve vaginal atrophy in postmenopausal women. A limitation of this pilot study is that it was based on a small study population hence the results should be regarded with caution. Larger studies are in progress to establish the possibility of using oxytocin as a clinical treatment for vaginal atrophy.
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http://dx.doi.org/10.1258/mi.2011.011030DOI Listing
December 2011

Vitamin D induction of the human antimicrobial Peptide cathelicidin in the urinary bladder.

PLoS One 2010 Dec 14;5(12):e15580. Epub 2010 Dec 14.

Department of Microbiology, Tumor and Cell Biology, Division of Clinical Microbiology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.

The urinary tract is frequently being exposed to potential pathogens and rapid defence mechanisms are therefore needed. Cathelicidin, a human antimicrobial peptide is expressed and secreted by bladder epithelial cells and protects the urinary tract from infection. Here we show that vitamin D can induce cathelicidin in the urinary bladder. We analyzed bladder tissue from postmenopausal women for expression of cathelicidin, before and after a three-month period of supplementation with 25-hydroxyvitamin D3 (25D3). Cell culture experiments were performed to elucidate the mechanisms for cathelicidin induction. We observed that, vitamin D per se did not up-regulate cathelicidin in serum or in bladder tissue of the women in this study. However, when the bladder biopsies were infected with uropathogenic E. coli (UPEC), a significant increase in cathelicidin expression was observed after 25D3 supplementation. This observation was confirmed in human bladder cell lines, even though here, cathelicidin induction occurred irrespectively of infection. Vitamin D treated bladder cells exerted an increased antibacterial effect against UPEC and colocalization to cathelicidin indicated the relevance of this peptide. In the light of the rapidly growing problem of resistance to common urinary tract antibiotics, we suggest that vitamin D may be a potential complement in the prevention of UTI.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0015580PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001888PMC
December 2010

Different estrogen sensitivity of urogenital tissue from women with and without stress urinary incontinence.

Neurourol Urodyn 2009 ;28(6):516-20

Department of Clinical Science, Karolinska Institute, Karolinska University Hospital Huddinge, Huddinge, Sweden.

Aims: Oral hormone replacement therapy (HRT) based on estradiol-17beta (E2), E2 esters or conjugated equine estrogens gives rise to huge amounts of circulating estrone (E1) as a result of the first liver pass. E1 is an estrogen (ER) receptor agonist but has also been reported to act as a partial E2 antagonist in vitro. Our aim was to investigate the influence of circulating estrogens on estrogen sensitivity of urogenital tissue collagen turnover in patients with stress urinary incontinence (SUI) and in urologically healthy women, with and without HRT, in view of possible effects of E1 as a partial E2 antagonist.

Methods: Markers of collagen turnover, the carboxy-terminal propeptide of type I procollagen (PICP), the carboxy-terminal telopeptide of type I collagen (ICTP) and the amino-terminal propeptide of procollagen III (PIIINP) were assayed in urogenital tissue homogenates and E1 and E2 were analyzed in serum from 54 patients with SUI and 29 urologically healthy women.

Results: In the total control group only a significant positive correlation was found between E2 and T-PICP. Lowering the upper serum E1 limit resulted in significant positive correlations also between E2 and T-PIIINP and finally also between E2 and T-ICTP. This pattern was found also in subgroups of post- and premenopausal controls. No association between serum E2 and collagen turnover markers and no effects of lowering the upper serum E1 limit was found in the total and postmenopausal SUI patients, while the correlation pattern in premenopausal SUI patients showed some resemblance to that in the controls.

Conclusion: At physiological E1 levels E2 increases collagen turnover in urogenital tissue in urologically healthy women but not in women with SUI in general; however, there was a certain effect of E2 in premenopausal but not in postmenopausal SUI patients. Urogenital tissue in SUI patients and in urologically healthy women may differ in estrogen sensitivty and in SUI patients this difference may be related to menopause. Circulating E1, which is present in huge amounts during oral HRT, may act as an estrogen receptor agonist as well as a partial E2 antagonist also in humans in vivo.
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http://dx.doi.org/10.1002/nau.20710DOI Listing
November 2009

Retest reliability of surface electromyography on the pelvic floor muscles.

Neurourol Urodyn 2009 ;28(5):395-9

Department of Physical therapy, Karolinska University Hospital, Stockholm, Sweden.

Aims: The aim of the current study was to evaluate the retest reliability of repeated intravaginal surface electromyography (surface EMG) of the pelvic floor muscles in healthy women, who were able to perform correct pelvic floor muscle contractions.

Methods: Seventeen nullipara women in the age of 20-35 years completed the measurements. The surface EMG was performed with the subjects in supine position with knees bent. The surface and ground electrodes were attached to a vaginal probe. A total of three test sessions were conducted, two on the same day with 30 minutes apart and a third 26-30 days later. Each test session consisted of three maximum contractions, 10 seconds hold and 10 seconds rest.

Results: Average activity, peak, work and baseline showed good to high reliability (ICC = 0.83-0.96). The reliability was somewhat higher in-between test session one and two compared with test session number three. Generally choosing the highest contraction in one test session resulted in a slightly higher ICC than taking an average result of all three contractions.

Conclusions: The current study shows that surface EMG is a reliable method of assessing pelvic floor muscle activity in healthy women. Neurourol. Urodynam. 28:395-399, 2009. (c) 2009 Wiley-Liss, Inc.
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http://dx.doi.org/10.1002/nau.20648DOI Listing
September 2009

Efficacy and safety of duloxetine in elderly women with stress urinary incontinence or stress-predominant mixed urinary incontinence.

Maturitas 2008 Jun 10;60(2):138-47. Epub 2008 Jun 10.

Secretariaat Gynaecologie F1, Antonius Hospital, Koekoekslaan 1, Nieuwegein, The Netherlands.

Objectives: To evaluate the efficacy and safety of duloxetine in community-dwelling women > or =65 years with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (S-MUI) versus placebo.

Methods: Patients were randomly assigned for 12 weeks to placebo (N=134) or duloxetine (N=131) (20mg twice daily [BID] for 2 weeks and 40 mg BID for an additional 10 weeks), followed by a double-blind 4-week dose de-escalation/discontinuation phase. The primary efficacy variable was the percent change in incontinence episode frequency (IEF) from baseline to endpoint. Other variables included absolute IEF change, responder rate, changes in mean time between voids (MTBV), weekly continence pad usage, the impact of treatment on quality of life, patient's global impression of improvement (PGI-I), and changes in depression and cognition.

Results: Duloxetine-treated patients had a significantly greater decrease from baseline to endpoint in mean IEF/week than placebo-treated patients (-52.47% vs. -36.70%, P<0.001). The IEF responder rate (> or =50% reduction in IEF/week) was 57.1% in the duloxetine group and 35.2% in the placebo group (P<0.001). Significant benefits of duloxetine were also demonstrated for weekly continence pad usage (P=0.011), MTBV (P<0.001), incontinence quality of life questionnaire (I-QOL) scores (P<0.001), and PGI-I ratings (P<0.001). Patients with depressive symptoms and cognitive impairments were few and changes were insignificant. The proportion of patients with > or =1 treatment-emergent adverse event (TEAE) was similar with both treatments, but dry mouth, fatigue, constipation, and hyperhidrosis were significantly more common in women taking duloxetine.

Conclusions: Duloxetine is a safe and effective treatment for elderly women with symptoms of SUI or S-MUI.
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http://dx.doi.org/10.1016/j.maturitas.2008.04.012DOI Listing
June 2008

Endocrine status and markers of collagen synthesis and degradation in serum and urogenital tissue from women with and without stress urinary incontinence.

Neurourol Urodyn 2007 ;26(3):410-5

Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden.

Aims: To investigate possible differences in androgen/estrogen status between patients with stress urinary incontinence (SUI) and healthy women's and to study possible associations between circulating estrogens and androgens on the one hand and collagen synthesis and metabolism in urogenital tissue on the other.

Methods: Markers of collagen turnover, the carboxy-terminal propeptide of type I procollagen (PICP), the carboxy-terminal telopeptide of type I collagen (ICTP), and the amino-terminal propeptide of procollagen III (PIIINP), were assayed in urogenital tissue homogenates and estradiol-17beta (E2), total testosterone (T), and sex-hormone-binding globulin (SHBG) were assayed in peripheral serum from 58 patients with SUI and 30 urologically healthy women. Apparent concentrations of free testosterone (fT) were calculated from T, SHBG, and a fixed albumin value.

Results: Significant positive correlations were found between E2 and PICP in controls and between E2 and ICTP in SUI patients without exogenous hormones. Significant negative and sometimes strong correlations were found between serum T and fT on the one hand and all three collagen turnover markers on the other. These correlations were strengthened when parity and/or body mass index (BMI) were reduced. No correlations between T and fT and collagen turnover markers were found in the controls. There were no significant differences between any of the groups in serum E2, T, or fT.

Conclusion: Estrogens may increase collagen turnover in urogenital tissue, however, the clinical significance of this is still unclear. Androgens may affect urogenital tissue negatively by slowing down collagen turnover, probably by inhibition of matrix metalloprotease (MMP) synthesis and/or activity. Urogenital tissue in SUI patients and in urologically healthy women may differ in androgen sensitivity.
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http://dx.doi.org/10.1002/nau.20335DOI Listing
June 2007

Treatment of stress urinary incontinence with non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel : An analysis of utility and cost.

Clin Drug Investig 2006 ;26(10):583-91

European Health Economics SAS, Mulhouse, France.

Background: The Zuidex system is a treatment for stress urinary incontinence comprising four prefilled syringes of non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and the Implacer device. This study aimed to investigate utility (patients' preferences for given health states) with NASHA/Dx gel therapy and to compare resource utilisation of NASHA/Dx gel treatment with tension-free vaginal tape (TVT).

Methods: Utility was measured using EuroQol (EQ-5D), a generic utility instrument. For the cost of NASHA/Dx gel treatment, data were collected prospectively from participants in a 12-month efficacy study (n = 82). Retrospective analysis of a comparable group of patients (n = 77; 3-6 months' follow-up) was used to obtain equivalent costs for TVT. Costs were analysed for both Sweden and France.

Results: NASHA/Dx gel produced a utility gain of 0.048 at 3 months and 0.014 at 12 months. The estimated mean total 3-month cost per patient with NASHA/Dx gel was euro 2412 in Sweden and euro 2005 in France. The corresponding values for 12 months, including 14% of patients undergoing TVT, were euro 3370-euro 3417 and euro 2935-euro 2976 for Sweden and France, respectively. In comparison, the total costs of treatment with TVT over 3-6 months were euro 3169-euro 3504 and euro 5181-euro 5471 for Sweden and France, respectively.

Conclusions: NASHA/Dx gel provides utility benefits that are similar to those previously reported for TVT and, depending on the country in which the treatment is performed, are associated with similar or lower overall costs in the short to medium term. From an economic perspective, NASHA/Dx gel could be considered at least as favourable as TVT, pending the availability of long-term effectiveness data.
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http://dx.doi.org/10.2165/00044011-200626100-00005DOI Listing
January 2007

The clinical diagnosis of pelvic inflammatory disease--reuse of electronic medical record data from 189 patients visiting a Swedish university hospital emergency department.

BMC Womens Health 2006 Oct 21;6:16. Epub 2006 Oct 21.

Department of Family and Community Medicine, Karolinska Institute, Huddinge, Stockholm, Sweden.

Background: The pelvic inflammatory disease (PID) diagnosis is mostly based on clinical findings. However, few studies have examined the clinical basis for the diagnostics of PID, which was the aim of this study.

Methods: A retrospective study was performed of 189 out-patients diagnosed as having PID at the obstetric and gynecological emergency department of a Swedish university hospital. Data on symptoms, signs, pelvic examination and laboratory tests were extracted from the electronic medical records in comparison with the diagnostic criteria of the PID Guideline of the US Center of Disease Control from 2002 (CDC 2002 Guidelines).

Results: Eight symptoms in varying combinations were associated with the PID diagnosis. Most of them are mentioned in the CDC 2002 Guidelines. Detected rates of C. Trachomatis (CT) and N. Gonorrhoeae (NG) were 5% and 0%, respectively, among the tested patients (CT = 52% and NG = 12%). The C-reactive protein was normal in the majority of tested patients.

Conclusion: The clinical basis for the diagnostics of PID was largely in accordance with the criteria in the CDC 2002 Guidelines. The limited number of CT tests performed is somewhat disappointing, considering the fact that effective disease prevention includes widespread CT screening. Further studies in different settings are needed in order to analyze how the testing rate for CT can be improved in clinical praxis.
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http://dx.doi.org/10.1186/1472-6874-6-16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1624808PMC
October 2006

Microvascular density, vascular endothelial growth factor A, and its receptors in endometrial blood vessels in patients with menorrhagia.

Fertil Steril 2005 Sep;84(3):692-700

Division of Obstetrics and Gynaecology, Department of Clinical Science, Karolinska Institutet, Huddinge University Hospital, Stockholm, Sweden.

Objective: To analyze the expression of vascular endothelial growth factor A (VEGF-A) and receptors (VEGFR-1 and VEGFR-2) in endometrial blood vessels, as well as microvascular density (MVD), in endometrial biopsy samples from idiopathic menorrhagia patients.

Design: Prospective clinical study.

Setting: University hospital, unit of gynecology.

Patient(s): Twenty-four patients with idiopathic menorrhagia and 18 healthy fertile women.

Intervention(s): Blood sampling for hormone measurement, hysteroscopy, and endometrial biopsy sampling. Endometrial biopsy samples were used for immunohistochemistry assessments and image analysis of stained endothelial structures for VEGF-A, VEGFR-1, VEGFR-2, and CD34.

Main Outcome Measure(s): Appearance of the endometrial vascular immunoreactivity for VEGF-A, VEGFR-1, and VEGFR-2, MVD and computer-assisted stereological analysis of immunoassayed blood vessels.

Result(s): Although the MVD did not differ between patients and controls, we observed that vascular expression of VEGF-A, VEGFR-1, and VEGFR-2 in capillaries was 1.8-fold, 1.8-fold, and 2.0-fold higher, respectively, in the menorrhagia group when assessed as the number of stained capillaries per unit area. There were also a twofold higher number of arterioles, which were VEGFR-2 positive in the menorrhagia group.

Conclusion(s): Up-regulation of VEGF-A and receptors VEGFR-1 and VEGFR-2 in capillaries in menorrhagia could be involved in abnormal endometrial vascular structure and permeability.
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http://dx.doi.org/10.1016/j.fertnstert.2005.03.065DOI Listing
September 2005

An open, multicentre study of NASHA/Dx Gel (Zuidex) for the treatment of stress urinary incontinence.

Eur Urol 2005 Sep;48(3):488-94

Sheffield Teaching Hospitals NHS Trust, Urology Research, Royal Hallamshire Hospital, South Yorkshire, UK.

Objective: The Zuidex system facilitates non-endoscopic urethral injection for stress urinary incontinence (SUI). It comprises four pre-filled syringes of non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and an Implacer device. This open, 12-month study was performed to evaluate the safety and efficacy of this system in women with SUI.

Methods: Patients were aged > or =18 years with a history of SUI for > or =12 months (hypermobility and/or intrinsic sphincter deficiency), had failed prior non-invasive therapy and were invasive-therapy naïve. Up to two treatments with NASHA/Dx gel were permissible (re-treatment was offered at week 8). Positive response to treatment was defined as a reduction in provocation test leakage of > or =50% compared with baseline. Efficacy was also measured by 24-hour pad weight test leakage, and number of incontinence episodes/24 hours.

Results: A total of 142 patients were enrolled, with a mean age of 55.7 years. The response rate was 78% at week 12, and 77% at month 12. Significant reductions in median provocation test leakage, 24-hour pad-weight test leakage and number of incontinence episodes/24 hours were observed at all time-points. At month 12, the median decreases from baseline in these three variables were 93%, 89% and 67%, respectively. Treatment-related adverse events were of a nature expected with urethral injection - most were transient, and of mild or moderate intensity.

Conclusions: Treatment with NASHA/Dx gel produced large, statistically significant reductions in urinary leakage sustained over 12 months and was well tolerated. These findings suggest that NASHA/Dx gel could be considered as an early intervention in treatment-naïve cases of SUI.
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http://dx.doi.org/10.1016/j.eururo.2005.05.007DOI Listing
September 2005

Conjugated estrogen/progestagen versus tibolone hormone replacement therapy in postmenopausal women: Effects on carbohydrate metabolism and serum sex hormone-binding globulin.

Maturitas 2006 Jan 16;53(1):89-96. Epub 2005 Jun 16.

Department of Clinical Science, Obstetrics and Gynecology, University of Umeå, Umeå, Sweden.

Objective: To study the effects of different types of continuous hormone replacement therapy on carbohydrate metabolism.

Method: Postmenopausal women were treated with conjugated estrogens, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg (CEE/MPA) or tibolone 2.5 mg daily for 13 28-day cycles. Serum glucose and insulin were measured before and during a 75 g oral glucose tolerance test (OGTT) at baseline and after 3, 6 and 13 cycles and areas under the curve (AUC) were calculated. Sex hormone-binding globulin (SHBG) was measured as an additional marker of nutritional and insulin status.

Results: Neither CEE/MPA 2.5mg nor tibolone had any effects on carbohydrate metabolism while AUC(insulin), AUC(glucose) and also body mass index (BMI) increased after 13 cycles of treatment in the CEE/MPA 5 mg group. SHBG increased significantly during CEE/MPA treatment and decreased significantly during treatment with tibolone. The effects on SHBG were less pronounced in the CEE/MPA 5mg group. Pretreatment SHBG showed significant negative correlations to BMI and to variables that may reflect a certain degree of insulin resistance, the most pronounced being fasting glucose. Changes in SHBG during treatment with tibolone were negatively correlated to pretreatment SHBG and positively to BMI, AUC(insulin) and fasting insulin resistance index, while no such correlations were found in the CEE/MPA groups. There were no correlations between changes in AUC(insulin) and AUC(glucose) on one hand and basal variables or treatment SHBG on the other in the CEE/MPA groups.

Conclusion: The effects of tibolone and CEE/MPA on carbohydrate metabolism were considered to have clinical significance only for CEE/MPA 5mg, indicating a less favourable role of the higher progestagen dose. The results further support the important role of metabolic and insulin status in the physiological regulation of SHBG and also indicate that the suppressive effect of tibolone on circulating SHBG is mainly depends on pretreatment SHBG levels. SHBG does not reflect changes in carbohydrate metabolism during CEE/MPA treatment.
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http://dx.doi.org/10.1016/j.maturitas.2005.03.003DOI Listing
January 2006

Markers of collagen synthesis and degradation in urogenital tissue from women with and without stress urinary incontinence.

Neurourol Urodyn 2005 ;24(4):319-24

Unit of Obstetrics and Gynecology, Department of Clinical Science and the Division of Clinical Chemistry, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, Huddinge, Sweden.

Aims: Multiparity and obesity are risk factors for stress urinary incontinence (SUI), but collagen synthesis and metabolism in the urogenital tissue itself may also affect its function and control of micturition. Whether changes in synthesis or degradation of collagen are part of the etiology of SUI is not known and published studies show diverging results. The aims of the present study was to investigate collagen turnover in urogenital tissue in women with SUI (n=71) and in urologically healthy women (n=31).

Methods: Markers of collagen synthesis and breakdown, the carboxy-terminal propeptide of type I procollagen (PICP), the carboxy-terminal telopeptide of type I collagen (ICTP), and the amino-terminal propeptide of procollagen III (PIIINP) were assayed in urogenital tissue homogenates and peripheral serum.

Results: In the total clinical material SUI patients were significantly older, had a significantly higher body mass index (BMI) and significantly lower serum PICP and tissue ICTP levels than the controls. When healthy controls were compared with SUI patients matched for age, BMI, parity, and hormonal/menopausal status (31 women in each group), the SUI patients had significantly lower serum concentrations of PICP and significantly lower tissue concentrations of PIIINP and ICTP than the controls. Within the total material of SUI patients, post-menopausal women with weak and strong HRT and pre-menopausal women had significantly lower S-ICTP concentrations than untreated post-menopausal patients. Significant negative correlations to parity were found for T-PIIINP and T-PICP and to BMI for T-ICTP.

Conclusions: The low tissue collagen marker levels in women with SUI suggest a reduced collagen turnover, which may negatively affect tissue strength and elasticity.
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http://dx.doi.org/10.1002/nau.20142DOI Listing
August 2005

Ecological effects of perorally administered pivmecillinam on the normal vaginal microflora.

Antimicrob Agents Chemother 2005 Jan;49(1):170-5

Division of Clinical Bacteriology, F82, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden.

The knowledge of the effects of antimicrobial agents on the normal vaginal microflora is limited. The objective of the present study was to study the ecological impact of pivmecillinam on the normal vaginal microflora. In 20 healthy women, the estimated day of ovulation was determined during three subsequent menstrual cycles. Microbiological and clinical examinations were performed on the estimated day of ovulation and on day 3 in all cycles and also on day 7 after ovulation in cycles 1 and 2. Anaerobic and facultative anaerobic gram-positive rods, mainly species of lactobacilli and actinomycetes, dominated the microflora. One woman was colonized on the third day of administration with a resistant Escherichia coli strain, and Candida albicans was detected in one woman on days 3 and 7 in cycle 2. No other major changes in the normal microflora occurred during the study. Administration of pivmecillinam had a minor ecological impact on the normal vaginal microflora.
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http://dx.doi.org/10.1128/AAC.49.1.170-175.2005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC538917PMC
January 2005

Treatment of stress urinary incontinence using a copolymer system: impact on quality of life.

BJU Int 2004 Nov;94(7):1040-3

Department of Urology, University Hospital Maastricht, The Netherlands.

Objective: To investigate the effect on quality of life (QoL) of a novel system for treatment of stress urinary incontinence (SUI).

Patients And Methods: In an open, prospective, multicentre study, 42 women not previously treated by invasive therapy and with urodynamically verified SUI received 4 x 1.0 mL or 4 x 0.7 mL of non-animal stabilized hyaluronic acid/dextranomer copolymer injected transurethrally into the urethra via the Implacer device (Zuidex system, Q-Med AB, Uppsala, Sweden). QoL was assessed using the King's Health Questionnaire. The patients' perception of treatment benefit and the number of incontinence episodes/24 h were also investigated.

Results: There were significant improvements over baseline in seven of 10 domains of the King's Health Questionnaire at 3 months, and these improvements were sustained at 1 year. For the change from baseline to 1 year, eight of 10 domains showed a significant positive correlation with the number of incontinence episodes/24 h. In terms of treatment benefit, most of the women perceived an improvement at 1, 3, 6 and 12 months. Of the 18 women requiring re-treatment, most perceived an improvement at 3, 6 and 12 months.

Conclusion: Treatment with the Zuidex system produced significant improvements over a year in both subjective QoL and objective incontinence measures, with a significant positive correlation between them.
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http://dx.doi.org/10.1111/j.1464-410X.2004.05101.xDOI Listing
November 2004

Efficacy and safety of a novel system (NASHA/Dx copolymer using the Implacer device) for treatment of stress urinary incontinence.

Urology 2004 Aug;64(2):276-81

Department of Urology, University Hospital Maastricht, Maastricht, The Netherlands.

Objectives: To investigate the efficacy and safety of non-animal-stabilized hyaluronic acid/dextranomer (NASHA/Dx) copolymer for transurethral injection using a new guiding instrument (the Implacer) for stress urinary incontinence.

Methods: In an open, prospective, multicenter study, 42 invasive therapy-naive female patients with stress urinary incontinence were given 4 x 1.0 mL or 4 x 0.7 mL of NASHA/Dx copolymer using the Implacer. The efficacy parameters, measured at baseline and 1, 3, 6, and 12 months after treatment, included cough-induced leak point pressure, urine leakage by provocation test, number of incontinence episodes in 24 hours, and patient perception of bladder condition, rated on a 6-point scale.

Results: The collected cough-induced leak point pressure data were not judged to be valid and reliable. Statistically significant reductions in median urine leakage were observed (P <0.0001), from 36 g (range 0.0-300) after 20 "jumping jacks" or vigorous coughs at baseline to 5.5 g (range 0.0-98) at 3 months and sustained at 12 months (7.0 g, range 0.0-98). Of the 42 patients, 32 (76%) demonstrated a degree of improvement in urine leakage at 3 and 12 months. The median number of incontinence episodes in 24 hours decreased significantly from 1.9 (range 0.0-24) at baseline to 0.4 (range 0.0-24) at 12 months (P <0.0001). At both 3 and 12 months, 29 patients (69%) had improved by at least one category on the 6-point patient perception scale. Treatment was well tolerated, and no complications were reported with use of the Implacer.

Conclusions: The results of this study indicate that a novel system (NASHA/Dx copolymer insertion using the Implacer) is an effective and well-tolerated treatment for invasive therapy-naive patients with stress urinary incontinence, with improvement sustained for at least 12 months. These encouraging results warrant additional study.
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http://dx.doi.org/10.1016/j.urology.2004.03.017DOI Listing
August 2004