Cost-effectiveness of an app-based treatment for urinary incontinence in comparison with care-as-usual in Dutch general practice: a pragmatic randomised controlled trial over 12 months.

OBJECTIVE: To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. POPULATION: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. METHODS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires). RESULTS: In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with € -161 (95% confidence interval [CI -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger incremental cost-effectiveness ratios (ICER: -€3696) and incremental cost-utility ratios (ICUR: €6379). CONCLUSION: App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care. TWEETABLE ABSTRACT: App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.

Exploring pelvic floor muscle function in men with and without pelvic floor symptoms: A population-based study.

BACKGROUND: Pelvic floor symptoms (PFS), such as lower urinary tract symptoms, defecation disorders, sexual problems, and genital-pelvic pain, are prevalent in men. Thorough physical assessments of the external anal sphincter (EAS) and the puborectal muscle (PRM) are the keys to unraveling the role of muscle dysfunction. OBJECTIVES: To explore associations within and between the EAS and PRM and between muscle (dys-) function and the number of male PFS. METHODS: This cross-sectional study purposively enrolled men aged ≥21 years with 0-4 symptoms from a larger study. After extensive external and internal digital pelvic floor assessment, we explored (1) agreement between muscle function of the EAS versus PRM (using cross tabulation), (2) associations within and between the EAS and PRM (using heatmaps), and (3) associations between muscle function and number of PFS (using a visual presentation [heatmaps] and χ2  tests). RESULTS: Overall, 42 out of 199 men (21%) had completely normal muscle function. Sixty-six (33.2%) had no symptoms, of which 53 (80%) had some degree of muscle dysfunction. No clear dose-response relationship existed between muscle (dys-) function and the number of symptoms. The PRM showed both more dysfunction and severer dysfunction than the EAS. CONCLUSIONS: No clear association exists between muscle dysfunction and the number of symptoms, and the absence of PFS does not indicate normal muscle function for all men. Dysfunction levels are highest for the PRM. Further pelvic floor muscle research is warranted in men with PFS.

Exploring concomitant pelvic floor symptoms in community-dwelling females and males.

OBJECTIVES: Researchers and clinicians tend to focus on one pelvic floor symptom (PFS) at the time. However, the pelvic floor acts as one functional unit, increasing the likelihood of concurrent PFS in patients with pelvic floor dysfunction. There is also a paucity of literature on the prevalence of concomitant PFS, especially in males. Therefore, we explored the occurrence of concomitant PFS in community-dwelling males and females. MATERIALS AND METHODS: This prospective observational population-based cohort study included males and females aged ≥16 years from a single Dutch municipality. Participants completed validated questionnaires on lower urinary tract symptoms (LUTS), defecation problems, sexual dysfunction, pelvic pain, and pelvic organ prolapse. Medical general practitioner records were examined. Furthermore, a randomly selected group of non-responders aged <80 years received a short questionnaire, to study response bias. RESULTS: We invited 11 724 people, among which 839 females and 566 males completed the questionnaires. Of the female participants, 286 (34.1%) reported no PFS, and 251 (29.9%) reported two or more PFS. The most prevalent PFS clusters in females were sexual dysfunction and pelvic pain, sexual dysfunction and defecation problems, LUTS and defecation problems, and LUTS, defecation problems, and pelvic pain. Of the male participants, 212 (37.5%) reported no PFS, and 191 (33.7%) reported two or more PFS. The most prevalent clusters in males were sexual dysfunction and LUTS, defecation problems and LUTS, and sexual dysfunction, LUTS, and defecation problems. CONCLUSION: A considerable overlap existed between PFS, with differences in PFS clusters between females and males. Of note, females reported pelvic pain more than males. We conclude that healthcare providers should address all PFS in males and females.

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial.

PURPOSE: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

Dutch guidelines for physiotherapy in patients with stress urinary incontinence: an update.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is the most common form of incontinence impacting on quality of life (QOL) and is associated with high financial, social, and emotional costs. The purpose of this study was to provide an update existing Dutch evidence-based clinical practice guidelines (CPGs) for physiotherapy management of patients with stress urinary incontinence (SUI) in order to support physiotherapists in decision making and improving efficacy and uniformity of care. MATERIALS AND METHODS: A computerized literature search of relevant databases was performed to search for information regarding etiology, prognosis, and physiotherapy assessment and management in patients with SUI. Where no evidence was available, recommendations were based on consensus. Clinical application of CPGs and feasibility were reviewed. The diagnostic process consists of systematic history taking and physical examination supported by reliable and valid assessment tools to determine physiological potential for recovery. Therapy is related to different problem categories. SUI treatment is generally based on pelvic floor muscle exercises combined with patient education and counseling. An important strategy is to reduce prevalent SUI by reducing influencing risk factors. RESULTS: Scientific evidence supporting assessment and management of SUI is strong. CONCLUSIONS: The CPGs reflect the current state of knowledge of effective and tailor-made intervention in SUI patients.

Prevalence of double incontinence, risks and influence on quality of life in a general female population.

BACKGROUND: Urinary incontinence (UI) and anal incontinence (AI) are complaints with impact on quality of life (QOL). Few data are available on prevalence of double incontinence (DI) in the general female population. OBJECTIVE: To determine prevalence of UI, AI, and DI, their associations with age, parity, and effects on QOL. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study on a general female population, aged 45-85 years. MEASUREMENTS: Validated questionnaires measuring pelvic floor dysfunction and QOL. A short questionnaire was used for non-responders. Analyses were performed with Chi-square tests, ANOVA, and logistic regression. RESULTS: Response rate was 62.7% (1,869/2,979); 59% of non-responders filled in the short questionnaire (620/1,051). No significant differences in stress urinary incontinence, vaginal bulging, solid stool incontinence and parity were found between responders and non-responders. DI with and without flatal incontinence were reported by 7.7% and 35.4%, respectively. Women with urge urinary incontinence (UUI) alone had an OR of 4.3 (95% CI 2.4-7.9) for liquid stool incontinence, 1.6 (95% CI 0.5-4.9) for solid stool incontinence and 2.4 for flatal incontinence (95% CI 1.5-3.8). Women with AI had an OR of 5.8 (95% CI 1.8-18.2) for UUI. Women with DI including flatus reported significantly poorer QOL. Limitation of the study was the lack of objective clinical validation of symptoms, which may have influenced the real prevalence data. CONCLUSIONS: Most important relation was found between UUI and liquid stool incontinence (OR 4.3). We recommend that clinicians take the history of patients with UUI or mixed urinary incontinence to exclude the co-existence of AI.

Symptomatic pelvic organ prolapse and possible risk factors in a general population.

OBJECTIVE: We sought to examine the prevalence of pelvic organ prolapse (POP) symptoms and risk factors in a general white population. STUDY DESIGN: This was a cross-sectional study. All female residents aged 45-85 years in a small Dutch city received validated questionnaires. Women were classified as symptomatic if they reported feeling and/or seeing vaginal bulge. RESULTS: Response rate was 62.7% (1869/2979). Prevalence of POP was 11.4%. Multivariate analysis revealed POP symptoms during pregnancy, a maternal history of POP, and heavy physical work, with a total population-attributable risk of 46%. CONCLUSION: There is high prevalence of symptomatic POP in a general white population of which independent risk factors are POP symptoms during pregnancy, a maternal history of POP, and heavy physical work. Clinicians should focus on risk factors in counseling of (pregnant) women to inform women to be aware of further exposures for themselves and their daughters.

Prediction model and prognostic index to estimate clinically relevant pelvic organ prolapse in a general female population.

INTRODUCTION AND HYPOTHESIS: Estimation on prevalence and distribution of pelvic organ prolapse (POP) signs in a general female population is difficult. We therefore developed and validated a prediction model and prognostic instrument. METHODS: Questionnaires were sent to a general female population (45-85 years). A random sample underwent vaginal examination for POP (POPQ). A prediction model was developed using multivariate analysis and validated in a subgroup of participants. RESULTS: Positive questionnaire-response rate was 46.8% (1,397 of 2,979). From the questionnaire group, 649 women were vaginally examined (46.5%). Prevalence of clinically relevant POP was 21%. Multivariate analysis demonstrated significantly higher odds ratios on the report of vaginal bulging, parity > or = 2 and a mother with POP. The receiver operating characteristic curve showed areas under the curve of 0.672 and 0.640. CONCLUSIONS: The prevalence of POP at or beyond the hymen could be estimated in a general female population using our prediction model with 17 questions and our POP score chart with eight questions.

The prevalence of pelvic organ prolapse symptoms and signs and their relation with bladder and bowel disorders in a general female population.

INTRODUCTION AND HYPOTHESIS: In selected populations, pelvic organ prolapse (POP) was associated with bladder/bowel symptoms, but data on the general female population are lacking. Our aim was to obtain normative data on the prevalence of POP and pelvic floor dysfunction (PFD) symptoms and signs and to identify associations. METHODS: Validated questionnaires on POP and PFD (urogenital distress inventory, (UDI) and defaecation distress inventory (DDI)) were sent to a general population of 2,979 women (aged 45-85 years). Data were analysed using the Kruskal-Wallis test, chi square test and Spearman's rank correlation coefficient. RESULTS: Response rate was 62.7%. Associations between POP stage and parity (0.002) and vaginal bulging (<0.001) are significant. Anatomical locations of POP and PFD symptoms correlated significantly with incontinence of flatus, feeling anal prolapse, manual evacuation of stool, vaginal bulging, constipation and pain during faecal urge (p < or = 0.005). CONCLUSIONS: Strategies should be developed to alleviate obstructive bowel disorders associated with POP.

Pelvic floor muscle function in a general female population in relation with age and parity and the relation between voluntary and involuntary contractions of the pelvic floor musculature.

INTRODUCTION AND HYPOTHESIS: The objective of this study is to describe pelvic floor muscle function (PFMF) in relation to age and parity in a general female population and to test whether strength/endurance measurements represent all functions of the pelvic floor musculature. METHODS: A cross-sectional study was performed on 95% of the women aged 45-85 years from a small Dutch town. Validated questionnaires were used to obtain general information, and vaginal examination to test PFMF was performed on 649 women. Chi-square tests were used to analyse the relation between PFMF versus age and parity. Analysis of variance was used to compare muscle strength and endurance to the other PFMF items. RESULTS: Response rate to the questionnaire was 62.7% (1,869/2,979). PFM strength and endurance are not positively associated with the effective involuntary muscle contractions during coughing. CONCLUSIONS: Voluntary muscle contractions decreased with age, but there was no relation with parity. Muscle strength and endurance measurements alone are not sensitive enough to determine PFMF.

Vaginal noise: prevalence, bother and risk factors in a general female population aged 45-85 years.

INTRODUCTION AND HYPOTHESIS: Vaginal noise (VN) is a symptom of pelvic floor (PF) dysfunction and has been described in a few studies. No other risk factors have been described besides parity and pelvic organ prolapse (POP). Underlying mechanisms of VN are unclear. Aims of this study were to describe prevalence, bother and relation between VN and PF (muscle)(dys)function. METHODS: A cross-sectional study was performed on a general population of 2,921 women (aged 45-85 years). Questionnaires were filled in by 1,397 women, and 800 were selected at random to undergo vaginal examination for POP Quantification and PF muscle function assessment. Chi-square tests, Student's t test and multivariate logistic regression were performed (P < 0.05). RESULTS: Response rate was 62.7%. Prevalence of VN was 12.8%; 72.1% reported only a little bother. Odds ratios for parity and solid stool were high. CONCLUSIONS: VN was strongly related to many symptoms of pelvic floor dysfunction, but it was only causing a little bother.