Usage of a Web-Based eHealth Intervention for Women With Stress Urinary Incontinence: Mixed Methods Study.

BACKGROUND: Stress urinary incontinence (SUI) is highly prevalent among women and has an impact on physical and mental well-being. eHealth with pelvic floor muscle training (PFMT) has shown to be effective in reducing complaints. The usage and nonusage attrition of eHealth for SUI is unknown, but knowledge about users and their usage patterns is crucial for implementation purposes. OBJECTIVE: This study aimed to evaluate how an eHealth intervention for SUI was used and by whom, explore reasons for nonusage attrition, and determine what factors are associated with usage. METHODS: In this observational, mixed methods study, women with SUI independently registered to a web-based eHealth intervention, Baas over je blaas, a translation of the Swedish internet program Tät-treatment of stress urinary incontinence. Log-in data were collected during 3-month access to the website, and surveys were sent at baseline. Participants were divided into three user groups (low, intermediate, and high) and were compared based on sociodemographic and incontinence-related characteristics. Nominal logistic regression analysis was used to study factors associated with eHealth usage. Qualitative content analysis was used for open-ended questions about nonusage attrition and about facilitators of and barriers to eHealth usage. RESULTS: Participants (n=561) had a mean age of 50.3 (SD 12.1) years, and most of them (340/553, 61.5%) had never visited a health care professional for SUI before. Most users were low users (295/515, 57.3%), followed by intermediate users (133/515, 25.8%) and high users (87/515, 16.9%). User groups differed significantly in age (48.3, SD 12 years; 52.1, SD 11.6 years; and 55.3, SD 10.9 years; P<.001) and in their expected ability to train the pelvic floor muscles (7.5, SD 1.4; 7.7, SD 1.4; and 8.1, SD 1.5 for low, intermediate, and high users, respectively; P=.006). Nonusage attrition was mainly caused by problems in integrating PFMT into everyday life. High age (>50 years), previous PFMT, and high expected ability to train the pelvic floor muscles are associated with high usage. Facilitators for eHealth usage were the clear explanation of exercises and the possibility of self-management. Barriers were its noncommittal character and the absence of personal contact. CONCLUSIONS: eHealth fulfills a need for women with SUI who have never received treatment. Those who discontinued prematurely did so mainly because it was difficult to integrate the training schedule into their everyday lives. High eHealth usage was more likely for women aged >50 years, with previous PFMT, and with high expectations about their ability to train the pelvic floor muscles. Knowledge of these user characteristics can guide clinicians and correct their misunderstandings about the suitable target population for this intervention. Furthermore, strategies for reinforcing expectations and self-efficacy are important to upscale eHealth usage, together with paying attention to people's need for personal contact. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13164.

Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire - IUGA Revised (PISQ-IR).

BACKGROUND: To put statistically significant changes in patient reported outcome measurement (PROM) questionnaires into a clinical perspective, the concept of the minimal clinically important difference (MCID) can be used. AIM: To determine the MCID for the summary score for sexually active (SA) women of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), a validated instrument which assesses sexual functioning (SF) for patients suffering from a symptomatic pelvic floor disorder. METHODS: Patients participating in a multicentre prospective cohort study comparing pessary therapy with surgery for a symptomatic pelvic organ prolapse (POP) filled in the PISQ-IR at baseline and 12 months' follow-up. We used both an anchor-based as well as a distribution-based method to calculate the MCID for both treatment groups. The Patient Global Impression of Improvement (PGI-I) questionnaire and PISQ-IR question 19a about satisfaction with sexual functioning were used as anchors. For the distribution-based approach we used the effect size (ES). OUTCOMES: MCID for the SA summary score of the PISQ-IR. RESULTS: Data of 243 women were used to calculate the MCID. In the pessary group, Kendall's tau-b correlation coefficients between the PISQ-IR summary score and both anchors were below the cut-off of 0.21, which implies the anchors cannot be used to calculate an MCID. In our surgery group, the PISQ-IR question 19a met the anchor criteria and 0.31 points increase in the PISQ-IR summary score was equal to an improvement of 1 point on question 19a about satisfaction with sexual functioning. CLINICAL IMPLICATIONS: Future research on this subject should focus on clinical relevance of results rather than statistical significance only. STRENGTHS & LIMITATIONS: Our main strength is the fact that we used both anchor-based and distribution-based methods to determine our MCID. Secondly, we set out to determine an MCID for both treatment groups separately, which relatively enhances the generalisability of our results. A limitation is that we were not able to estimate an MCID for the pessary group. Pruijssers B, van der Vaart L, Milani F, et al. Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire - IUGA Revised (PISQ-IR). J Sex Med 2021;18:1265-1270. CONCLUSION: We estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group.

Dutch translation and validation of the pelvic organ prolapse/incontinence sexual questionnaire-IUGA revised (PISQ-IR).

INTRODUCTION AND HYPOTHESIS: Condition-specific sexual questionnaires are important patient-reported outcome measures. The aim of this study was to translate and validate the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-International Urogynecology Association Revised (PISQ-IR) into Dutch. METHODS: The translated PISQ-IR was linguistically validated, followed by psychometrical validation among women presenting with symptoms of pelvic floor dysfunction in urogynecology clinics. For analysis of the criterion validity, the Pelvic Floor Dysfunction Inventory-20 (PFDI-20) and Female Sexual Function Index (FSFI) were used. Descriptive statistics, floor and ceiling effects, internal consistency using Cronbach's alpha coefficient and Pearson's and Spearman's correlations were calculated for all PISQ-IR subscales. RESULTS: The PISQ-IR was completed by 220 women, of whom 61 (27.7%) considered themselves not sexually active (NSA) and 159 (72.3%) sexually active (SA). The mean age of participating women was 57 years; 49.5% reported symptoms of pelvic organ prolapse (POP), 66.8% urinary incontinence and 2.3% anal incontinence. The PISQ-IR subscales were analyzed separately for SA and NSA women with Cronbach's alpha coefficient ranging from 0.61 to 0.87. Moderate to high correlations were observed between PISQ-IR subscales and corresponding FSFI subscales and a moderate correlation between urinary distress and the condition impact (CI) subscale among NSA subjects. CONCLUSIONS: The Dutch PISQ-IR demonstrated a good internal consistency and criterion validity compared with the FSFI, but criterion validity compared with the PFDI-20 was poor except for urinary distress in NSA women and needs further attention.

Cost-effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care: Study protocol of the COCON study.

BACKGROUND: Guidelines on urinary incontinence recommend that absorbent products are only used as a coping strategy pending definitive treatment, as an adjunct to ongoing therapy, or for long-term management after all treatment options have been explored. However, these criteria are rarely met and a significant share of long-term product users could still benefit from therapeutic interventions recommended in guidelines for urinary incontinence. Better implementation of these guidelines can potentially result in both health benefits for women and long-term cost savings for society. The aim of the COCON study is to evaluate the (cost-)effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care in comparison with usual care for urinary incontinent women aged 55 years and over who use absorbent products. METHODS: This randomised clinical trial compares usual care with a nurse-led intervention to optimise implementation of guideline-concordant continence care. Women (anticipated N = 160) are recruited in 12 community pharmacies in three Dutch regions, and are eligible for trial entry when they are 55 years and over, community-dwelling and long-term users of absorbent products (≥4 months) reimbursed by health insurance. Measurements are administered at baseline, 3, 6 and 12 months. Primary outcome is severity of urinary incontinence (ICIQ-UI SF); other outcomes include health related quality of life (EQ-5D-5 L), use of absorbent products (in accordance with the recommended criteria in guidelines) (yes/no), and societal costs. Mixed model analysis will be performed to compare (the course) of outcomes between groups. The economic evaluation will be performed from a societal perspective. The implementation process is investigated using the Tailored Implementation for Chronic Diseases (TICD) framework. DISCUSSION: Results will add to current knowledge of the (cost-)effectiveness of nurse-led primary healthcare to improve guideline-concordant care for older women with urinary incontinence. In addition, the results will provide more insight into care needs and health service utilization of this group of women, as well as into use of absorbent products in accordance with the recommended criteria in guidelines. Finally, results will increase our understanding of the intervention's uptake and could provide useful insights for future dissemination and sustenance. TRIAL REGISTRATION: Dutch Trial Register NTR4396, registered 13-January-2014.

The relation between usage of an eHealth intervention for stress urinary incontinence and treatment outcomes: an observational study.

BACKGROUND: Stress urinary incontinence (SUI), though a prevalent condition among women, is undertreated in primary care. EHealth with pelvic floor muscle training is an evidence-based alternative to care-as-usual. It is unknown, however, how eHealth usage is related to treatment outcome, and this knowledge is required for general practitioners to implement eHealth in their practice. This study examines the relation between usage of eHealth for SUI and treatment outcomes by examining log data. Baseline factors were also explored for associations with treatment success. METHOD: In this pre-post study, women with SUI participated in "Baasoverjeblaas.nl", a web-based intervention translated from the Swedish internet intervention "Tät®-treatment of stress urinary incontinence". Usage was based on log data and divided into three user groups (low, intermediate and high). Online questionnaires were sent before, after treatment and at six-months follow-up. The relation between usage and the primary outcome - treatment success (PGI-) - was studied with a binomial logistic regression analysis. Changes in the secondary outcomes - symptom severity (ICIQ-UI SF) and quality of life (ICIQ-LUTSqol) - were studied per user group with linear mixed model analysis. RESULTS: Included were 515 users with a mean age of 50.5 years (12.0 SD). The majority were low users (n = 295, 57.3%). Treatment success (PGI-I) was reached by one in four women and was more likely in high and intermediate users than in low users (OR 13.2, 95% CI 6.1-28.5, p < 0.001 and OR 2.92, 95% CI 1.35-6.34, p = 0.007, respectively). Symptom severity decreased and quality of life improved significantly over time, especially among high users. The women's expected ability to train their pelvic floor muscles and the frequency of pelvic floor muscle exercises at baseline were associated with treatment success. CONCLUSION: This study shows that usage of eHealth for SUI is related to all treatment outcomes. High users are more likely to have treatment success. Treatment success is more likely in women with higher expectations and pelvic floor muscle training at baseline. These findings indicate that general practitioners can select patients that would be more likely to benefit from eHealth treatment, and they can enhance treatment effect by stimulating eHealth usage. TRIAL REGISTRATION: Landelijk Trial Register NL6570;  https://onderzoekmetmensen.nl/nl/trial/25463 .

Pelvic floor muscle problems mediate sexual problems in young adult rape victims.

INTRODUCTION: Prior studies have addressed sexual abuse and sexual function in adult women. No studies have focused on the effect of adolescence rape on sexual functioning. AIM: To investigate the effect of rape on sexual problems and on pelvic floor problems, as well as the mediating role of pelvic floor problems on sexual problems, in a homogenous group of victims of adolescence rape without a history of childhood sexual, physical, and/or emotional abuse. MAIN OUTCOME MEASURES: Sexual functioning and pelvic floor functioning were assessed using self-report questionnaires. METHODS: In this cross-sectional study, a group of 89 young women aged 18-25 years who were victimized by rape in adolescence was compared with a group of 114 nonvictimized controls. The rape victims were treated for posttraumatic stress disorder (PTSD) 3 years prior to participation in the study. RESULTS: Three years posttreatment, rape victims were 2.4 times more likely to have a sexual dysfunction (lubrication problems and pain) and 2.7 times more likely to have pelvic floor dysfunction (symptoms of provoked vulvodynia, general stress, lower urinary tract, and irritable bowel syndrome) than nonvictimized controls. The relationship between rape and sexual problems was partially mediated by the presence of pelvic floor problems. Rape victims and controls did not differ with regard to sexual activities. CONCLUSIONS: Rape victims suffer significantly more from sexual dysfunction and pelvic floor dysfunction when compared with nontraumatized controls, despite the provision of treatment for PTSD. Possibly, physical manifestations of PTSD have been left unaddressed in treatment. Future treatment protocols should consider incorporating (physical or psychological) treatment strategies for sexual dysfunction and/or pelvic floor dysfunction into trauma exposure treatments.

What Are the Short-term Benefits and Potential Harms of Therapeutic Modalities for the Management of Overactive Bladder Syndrome in Women? A Review of Evidence Under the Auspices of the European Association of Urology, Female Non-neurogenic Lower Urinary Tract Symptoms Guidelines Panel.

CONTEXT: Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. OBJECTIVE: To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. EVIDENCE ACQUISITION: The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions, and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. EVIDENCE SYNTHESIS: Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. CONCLUSIONS: Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. PATIENT SUMMARY: Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors.

Benefits and Harms of Conservative, Pharmacological, and Surgical Management Options for Women with Bladder Outlet Obstruction: A Systematic Review from the European Association of Urology Non-neurogenic Female LUTS Guidelines Panel.

CONTEXT: While the management of bladder outlet obstruction (BOO) in men has been a topic of several systematic reviews and meta-analyses, no such evidence base exists for female BOO. OBJECTIVE: The aim of this systematic review was to evaluate the benefits and harms of therapeutic interventions for the management of BOO in women. EVIDENCE ACQUISITION: This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. The study protocol was registered with PROSPERO (CRD42020183839). A systematic literature search was performed and updated by a research librarian in May 2021. The study population consisted of adult female patients diagnosed with BOO, who underwent treatment. EVIDENCE SYNTHESIS: Out of 6344 records, we identified 33 studies enrolling 1222 participants, of which only six randomized controlled trials (RCTs) were found. One placebo-controlled crossover randomized trial assessed the role of baclofen in 60 female patients with dysfunctional voiding. The trial met its primary endpoint with a significantly greater decrease in the number of voids per day in the baclofen group (-5.53 vs -2.70; p = 0.001). The adverse events were mild and comparable in both groups (25% vs 20%). One placebo-controlled crossover randomized trial assessed the role of sildenafil in 20 women with Fowler's syndrome. There were significant improvements from baseline in maximum urinary flow rate (Qmax), International Prostate Symptom Score (IPSS), and postvoid residual (PVR), but with no statistically significant difference when compared with placebo. In a large RCT including 197 female patients with functional BOO, the alpha-blocker alfuzosin significantly improved IPSS, Qmax, and PVR compared with baseline, but the differences were not statistically significant compared with the placebo group. Several small single-arm prospective series reported improvement of BOO-related symptoms and voiding parameters with urethroplasty, sling revision, urethral dilation, vaginal pessary, and pelvic organ prolapse repair. CONCLUSIONS: Evidence to support the use of conservative, pharmacological, and surgical treatments for BOO is scarce. PATIENT SUMMARY: According to the present systematic review of the literature, evidence to support the use of conservative, pharmacological, and surgical treatments for either anatomical or functional bladder outlet obstruction is scarce.

European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence.

CONTEXT: Female lower urinary tract symptoms (LUTS) are a common presentation in urological practice. Thus far, only a limited number of female LUTS conditions have been included in the European Association of Urology (EAU) guidelines compendium. The new non-neurogenic female LUTS guideline expands the remit to include these symptoms and conditions. OBJECTIVE: To summarise the diagnostic section of the non-neurogenic female LUTS guideline and the management of female overactive bladder (OAB), stress urinary incontinence (SUI), and mixed urinary incontinence (MUI). EVIDENCE ACQUISITION: New literature searches were carried out in September 2021 and evidence synthesis was conducted using the modified GRADE criteria as outlined for all EAU guidelines. A new systematic review (SR) on OAB was carried out by the panel for the purposes of this guideline. EVIDENCE SYNTHESIS: The important considerations for informing guideline recommendations are presented, along with a summary of all the guideline recommendations. CONCLUSIONS: Non-neurogenic female LUTS are an important cause of urological dysfunction. Initial evaluation, diagnosis, and management should be carried out in a structured and logical fashion based on the best available evidence. This guideline serves to present this evidence to health care providers in an easily accessible and digestible format. PATIENT SUMMARY: This report summarises the main recommendations from the European Association of Urology guideline on symptoms and diseases of the female lower urinary tract (bladder and urethra) not associated with neurological disease. We cover recommendations related to diagnosis of these conditions, as well as the treatment of overactive bladder, stress urinary incontinence, and mixed urinary incontinence.

European Association of Urology Guidelines on the Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 2: Underactive Bladder, Bladder Outlet Obstruction, and Nocturia.

CONTEXT: Female lower urinary tract symptoms (LUTS) are a common presentation in urological practice. Thus far, only a limited number of female LUTS conditions have been included in the European Association of Urology (EAU) guidelines compendium. The new non-neurogenic female LUTS guidelines expand the remit to include these symptoms and conditions. OBJECTIVE: To summarise the management of underactive bladder (UAB), bladder outlet obstruction (BOO), and nocturia in females. EVIDENCE ACQUISITION: The literature search was updated in September 2021 and evidence synthesis was conducted using modified GRADE approach as outlined for all EAU guidelines. A new systematic review on BOO was carried out by the panel for purposes of this guideline. EVIDENCE SYNTHESIS: The important considerations for informing guideline recommendations are presented, along with a summary of all the guideline recommendations. CONCLUSIONS: Non-neurogenic female LUTS are an important presentation of urological dysfunction. Initial evaluation, diagnosis, and management should be carried out in a structured and logical fashion on the basis of the best available evidence. This guideline serves to present this evidence to practising urologists and other health care providers in an easily accessible and digestible format. PATIENT SUMMARY: This report summarises the main recommendations from the European Association of Urology guideline on symptoms and diseases of the female lower urinary tract (bladder and urethra) not associated with neurological disease. We cover recommendations related to the treatment of underactive bladder, obstruction of the bladder outlet, and nighttime urination.

Diagnostic Tests for Female Bladder Outlet Obstruction: A Systematic Review from the European Association of Urology Non-neurogenic Female LUTS Guidelines Panel.

CONTEXT: Female bladder outlet obstruction (fBOO) is a relatively uncommon condition compared with its male counterpart. Several criteria have been proposed to define fBOO, but the comparative diagnostic accuracy of these remains uncertain. OBJECTIVE: To identify and compare different tests to diagnose fBOO through a systematic review process. EVIDENCE ACQUISITION: A systematic review of the literature was performed according to the Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist. The EMBASE/MEDLINE/Cochrane databases were searched up to August 4, 2020. Studies on women ≥18 yr of age with suspected bladder outlet obstruction (BOO) involving diagnostic tests were included. Pressure-flow studies or fluoroscopy was used as the reference standard where possible. Two reviewers independently screened all articles, searched reference lists of retrieved articles, and performed data extraction. The risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). EVIDENCE SYNTHESIS: Overall, 28 nonrandomised studies involving 10 248 patients were included in the qualitative analysis. There was significant heterogeneity regarding the characteristics of women included in BOO cohorts (ie, mixed cohorts including both anatomical and functional BOO). Pressure-flow studies ± fluoroscopy was evaluated in 25 studies. Transperineal Doppler ultrasound was used to evaluate bladder neck dynamics in two studies. One study tested the efficacy of transvaginal ultrasound. The urodynamic definition of fBOO also varied amongst studies with different parameters and thresholds used, which precluded a meta-analysis. Three studies derived nomograms using the maximum flow rate (Qmax) and voiding detrusor pressure at Qmax. The sensitivity, specificity, and overall accuracy ranges were 54.6-92.5%, 64.6-93.9%, and 64.1-92.2%, respectively. CONCLUSIONS: The available evidence on diagnostic tests for fBOO is limited and heterogeneous. Pressure-flow studies ± fluoroscopy remains the current standard for diagnosing fBOO. PATIENT SUMMARY: Evidence on tests used to diagnose female bladder outlet obstruction was reviewed. The most common test used was pressure-flow studies ± fluoroscopy, which remains the current standard for diagnosing bladder outlet obstruction in women. TAKE HOME MESSAGE: The available evidence on diagnostic tests for female bladder outlet obstruction is limited and heterogeneous. The most common test used was video-urodynamics, which remains the current standard for diagnosing bladder outlet obstruction in women.

Confirmation of Essure placement using transvaginal ultrasound.

STUDY OBJECTIVE: To evaluate the protocol for confirmation of satisfactory Essure placement using transvaginal ultrasound. DESIGN: Prospective multicenter cohort study (Canadian Task Force classification II-2). SETTING: Outpatient departments of 4 teaching hospitals in the Netherlands. PATIENTS: Eleven hundred forty-five women who underwent hysteroscopic sterilization using the Essure device between March 2005 and December 2007. INTERVENTION: Transvaginal ultrasound examination 12 weeks after uncomplicated successful bilateral placement or as indicated according to the transvaginal ultrasound protocol after 4 weeks, and hysterosalpingography (HSG) at 12 weeks to confirm correct placement of the device after 3 months. MEASUREMENTS AND MAIN RESULTS: The rate of successful placement was 88.4% initially. In 164 women (15%), successful placement was confirmed at HSG according the protocol. In 9 patients (0.84%), incorrect position of the device was observed at HSG. The cumulative pregnancy rate after 18 months was 3.85 per thousand women. CONCLUSION: Transvaginal ultrasound should be the first diagnostic test used to confirm the adequacy of hysteroscopic Essure sterilization because it is minimally invasive, averts ionizing radiation, and does not decrease the effectiveness of the Essure procedure.

Cost-effectiveness of duloxetine: the Stress Urinary Incontinence Treatment (SUIT) study.

OBJECTIVE: To assess the cost-effectiveness of duloxetine compared with conservative therapy in women with stress urinary incontinence (SUI). METHODS: Cost and outcome data were taken from the Stress Urinary Incontinence Treatment (SUIT) study, a 12-month, prospective, observational, naturalistic, multicenter, multicountry study. Costs were assessed in UK pound and outcomes in quality adjusted life years using responses to the EuroQol (EQ-5D); numbers of urine leaks were also estimated. Potential selection bias was countered using multivariate regression and propensity score analysis. RESULTS: Duloxetine alone, duloxetine in combination with conservative treatment, and conservative treatment alone were associated with roughly two fewer leaks per week compared with no treatment. Duloxetine alone and with conservative treatment for SUI were associated with incremental quality-adjusted life-years (QALYs) of about 0.03 over a year compared with no treatment or with conservative treatment alone. Conservative treatment alone did not show an effect on QALYs. None of the interventions appeared to have marked impacts on costs over a year. Depending on the form of matching, duloxetine either dominated or had an incremental cost-effectiveness ratio (ICER) below pound900 per QALY gained compared with no treatment and with conservative treatment alone. Duloxetine plus conservative therapy had an ICER below pound5500 compared with no treatment or conservative treatment alone. Duloxetine compared with duloxetine plus conservative therapy showed similar outcomes but an additional cost for the combined intervention. CONCLUSIONS: Although the limitations of the use of SUIT's observational data for this purpose need to be acknowledged, the study suggests that initiating duloxetine therapy in SUI is a cost-effective treatment alternative.

Patient characteristics impacting health state index scores, measured by the EQ-5D of females with stress urinary incontinence symptoms.

OBJECTIVE: To describe the characteristics of women seeking treatment for symptoms of stress urinary incontinence (SUI) and to investigate the association of SUI symptoms with generic health-related quality of life (HRQoL) as measured by the EuroQol (EQ-5D) instrument. METHODS: The Stress Urinary Incontinence Treatment (SUIT) study was a 12-month observational study in four European countries that evaluated the cost-effectiveness of duloxetine compared with other forms of nonsurgical intervention in the treatment of the symptoms of SUI. Four hundred thirty-one physicians observed women seeking treatment for their SUI, and recorded the care provided and the outcomes of that care at enrollment and at 3, 6 and 12 months afterward The impact of SUI on baseline HRQoL as expressed by the EQ-5D index score was assessed by linear and logistic regression. RESULTS: Three thousand seven hundred sixty-two women were enrolled into SUIT, with the largest patient group from Germany. Overall, the majority of women were postmenopausal, had a mean age of 58.0 years, were not current smokers, and tended to be overweight (mean body mass index [BMI]=27.7 kg/m2), with at least one comorbidity. The health state index scores were significantly and independently influenced by the presence of comorbidity(ies) affecting quality of life, total number of stress and urge incontinence episodes, urinary incontinence subtype, comorbidity(ies) affecting incontinence, BMI, socioeconomic status, educational status, age, and country. CONCLUSION: This article describes the characteristics of patients at the SUIT enrollment visit, and demonstrates that the number of incontinence episodes has a significant impact on the EQ-5D index score.

Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I) and in patients with genital prolapse and occult stress incontinence (CUPIDO II).

BACKGROUND: About 40% of all patients with genital prolapse report stress-incontinence. In about half of the 60% patients that do not report stress-incontinence, occult urinary stress-incontinence can be detected. In these patients stress-incontinence is masked due to kinking or compression of the urethra by the prolapse.In case surgical correction is indicated there are two strategies to manage patients with combined prolapse and (occult) stress incontinence. This strategy is either (i) a combination of prolapse surgery and stress-incontinence surgery or (ii) to correct the prolapse first and evaluate afterwards whether additional stress-incontinence surgery is indicated. The advantage of combining prolapse and stress-incontinence surgery is that only few patients report stress-incontinence following such combination. However, this combination has been associated with an increased risk on complications, of which the development of obstructive micturition symptoms, overactive bladder symptoms and bladder retention are the most important ones. Furthermore, combining two procedures may be unnecessary as performing only prolapse surgery may cure stress-incontinence. In the randomized CUPIDO trials both strategies are compared in patients with prolapse and evident stress incontinence (CUPIDO I trial) and in patients with prolapse and occult stress incontinence (CUPIDO II trial). METHODS/DESIGN: The CUPIDO trials are two multicenter randomized controlled trials in which women with stress urinary incontinence (SUI) or occult stress urinary incontinence (OSUI) are randomized to prolapse surgery combined with anti incontinence surgery (concomitant surgery) or to prolapse surgery only. Patients with at least stage 2 POP are eligible, women with evident SUI are randomized in CUPIDO I. Patients without SUI are eligible for CUPIDO II and will have urodynamic evaluation or a standardized redression test. Women with OSUI are randomized, women without OSUI are followed up but not randomized. The primary outcome measure is absence of SUI twelve months after surgery. Furthermore, economic evaluations are conducted, and the effectiveness of urodynamic investigation is evaluated against a non-invasive way to determine SUI in women with POP. A total of 450 women will be included in the study. TRIAL REGISTRATION: Trial registration http://www.trialregister.nl NTRR 1197 en 1070.

Protocol for Physiotherapy Or TVT Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence.

BACKGROUND: Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial. METHODS/DESIGN: A multi-centre randomised controlled trial will be performed for women between 35-80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands. TRIAL REGISTRATION: Nederlands trial register: NTR 1248.

An Electronic Health Intervention for Dutch Women With Stress Urinary Incontinence: Protocol for a Mixed Methods Study.

BACKGROUND: Stress urinary incontinence (SUI) is a common problem with a great potential influence on quality of life. Although SUI can be treated effectively with pelvic floor muscle training (PFMT), only a minority of women with this complaint seek help. An internet-based electronic health (eHealth) intervention could make care more accessible. The Swedish eHealth intervention Tät-treatment of Stress Urinary Incontinence offers PFMT and has shown to be effective in reducing symptoms in women with SUI. This intervention might be helpful for Dutch women too, but its adoption needs to be studied as the Netherlands differs from Sweden in terms of geographical characteristics and health care organization. OBJECTIVE: The objective of this protocol is to investigate the barriers and facilitators to the adoption of an eHealth intervention for Dutch women with SUI and the effects of this intervention. METHODS: We are conducting an explanatory sequential mixed methods study among 800 Dutch women with SUI who participate in the translated version of Tät-treatment of Stress Urinary Incontinence. This eHealth intervention takes 3 months. A pre-post study is conducted using surveys, which are sent at baseline (T0), 3 weeks after baseline (T1), posttreatment (T2), and 3 months posttreatment (T3). After the intervention, semistructured interviews will be held with 15 to 20 participants. The primary outcomes are barriers and facilitators to using the Tät-treatment of Stress Urinary Incontinence. This will also be analyzed among groups that differ in age and severity of incontinence. A thematic content analysis of the qualitative data will be performed. The secondary outcomes are: (1) effect on symptoms of urinary incontinence, (2) effect on quality of life, and (3) factors that are potentially associated with success. Effects will be analyzed by a mixed model analysis. Logistic regression analysis will be used to study what patient-related factors are associated with success. RESULTS: Enrollment started in July 2018 and will be finished by December 2019. Data analysis will start in March 2020. CONCLUSIONS: An eHealth intervention for Dutch women with SUI is promising because it can make treatment more accessible. The strength of this study is that it explores the possibilities for an internet-based-only treatment for women with SUI by using both quantitative and qualitative research methodologies. The study elaborates on existing results by using a previously tested and effective eHealth program. Insight into the barriers and facilitators to using this program can enhance the implementation of the intervention in the Dutch health care system. TRIAL REGISTRATION: Netherlands Trial Registry (NTR) NTR6956; https://www.trialregister.nl/trial/6570. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13164.

Incidence, pain, and mobility assessment of pregnant women with sacroiliac dysfunction.

OBJECTIVES: To determine the incidence of sacroiliac dysfunction in pregnancy and assess its progress during the course of the pregnancy. METHODS: The present prospective cohort study, performed between April 1, 2013, and May 31, 2016, enrolled primigravidae aged 25-35 years before 13 weeks of pregnancies who were experiencing back pain and did not have prior symptoms of sacroiliac dysfunction. Participants attended regular follow-up over 6 months and clinical functional tests were used to diagnose sacroiliac dysfunction. Women with sacroiliac dysfunction were assessed at 3-week intervals with a numeric pain rating scale (NPRS) and the pregnancy mobility index (PMI). RESULTS: Among 1500 women who fulfilled the inclusion criteria, 1181 (78.7%) were diagnosed with sacroiliac dysfunction and 1143 completed all follow-up. Pain assessed by the NPRS gradually worsened from the first toward the third trimester (P<0.001). The level of disability assessed by the PMI also increased from the beginning to the end of pregnancy (P<0.001). CONCLUSION: Sacroiliac dysfunction represents an important problem during pregnancy; pain severity and mobility problems increased during the course of pregnancy in the present study. AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12613000246785.

Effects of genital prolapse surgery on sexuality.

OBJECTIVE: A prospective study was performed to evaluate the effects of genital prolapse surgery on sexuality. Additionally we investigated which variables are risk factors for persistence or development of sexual problems after surgery. METHODS: All 82 patients participating in a randomized trial comparing vaginal and abdominal surgical correction of descensus uteri, were asked to complete the Questionnaire for screening Sexual Dysfunctions (QSD) before and at six months and one year after surgery. RESULTS: Sixty-two patients completed the questionnaire. General satisfaction about sexuality was significantly improved after surgery. Of 41 patients who were sexually active both before surgery and at one year after surgery, 28 (68.3%) patients reported sexual problems before surgery. In 13 (46.4%) of these patients, all sexual problems disappeared. Of the 13 patients without sexual problems before surgery, two patients reported de novo sexual problems. The relative risk on disappearance of sexual problems in patients with large cystocele was 1.5 (95% confidence interval 1.1-2.1) times higher than the risk in patients without large cystocele. CONCLUSION: Satisfaction about sexuality increases and the prevalence of sexual problems decreases in patients undergoing surgical correction of descensus uteri.