Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): Design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care

Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged >= 55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results. (C) 2013 Elsevier Ireland Ltd. All rights reserved

Active encouragement of older women with urinary incontinence in primary care to undergo diagnosis and treatment:A matched-pair cluster randomized controlled trial

OBJECTIVES: The URINO trial investigated the effect of offering treatment to older women with urinary incontinence in the general population, who had not sought help on their own initiative. STUDY DESIGN: In a cluster randomized trial, 14 general practitioners were matched into pairs and randomly allocated to an intervention or a control group. Women aged ≥55 years registered in the participating practices were asked about urinary incontinence via a postal questionnaire. Patients in the intervention group were assessed and treated whereas patients in the control group received standard care. MAIN OUTCOME MEASURES: Primary outcome was improvement (yes or no) of the severity of symptoms at 12-month follow-up measured with the Incontinence Severity Index. Secondary outcomes were the number of incontinence episodes per day and quality of life. The primary analysis was on an intention-to-treat basis with multiple imputation of missing data. A logistic regression model with correction for cluster randomization was fitted to estimate odds ratios (ORs). RESULTS: At 12 months, the severity of symptoms had improved in more patients in the intervention group (n166) than in the controls (n184) (OR 1.9; 95% CI 1.1-3.3). Also, the number of patients with fewer episodes of incontinence had increased (OR 2.5; 95% CI 1.5-4.1). No between-group differences in changes in quality of life were apparent (p0.14). CONCLUSIONS: It is recommended to encourage women in the general population aged ≥55 years with urinary incontinence to undergo diagnosis and treatment

The effect of systematic screening of older women for urinary incontinence on treatment uptake:The URINO trial

<p>Background: Female urinary incontinence is a common condition that has a negative influence on quality of life and generates high costs, but spontaneous help-seeking is limited. In the URINO trial the effects and cost-effectiveness of actively encouraging older women to undergo diagnostics and treatment for urinary incontinence were compared with usual care.</p><p>Objectives: To describe the design of the URINO trial and to give data on the effect of treatment uptake after screening. In the discussion, the criteria of Wilson and Jungner are applied to discuss whether screening for urinary incontinence is suitable.</p><p>Methods: In a cluster randomized trial all registered female patients aged >= 55 years received a screening questionnaire. The intervention consisted of actively encouraging women to undergo diagnostics, after which tailored treatment was offered. In the control group care as usual was offered, but uptake of diagnostics and treatment was not encouraged.</p><p>Results The response rate was 76%. 31% reported urinary incontinence; of these, 47% was willing to participate. All patients in the intervention group underwent diagnostics and treatment uptake was 80%; in the control group this was 2%.</p><p>Conclusion: To increase treatment uptake, screening must be followed by active encouragement for further diagnostics and treatment. Based on the principles of Wilson and Jungner, female urinary incontinence is a condition suitable for screening. The effect of treatment however needs further evaluation before screening can be recommended. The results of the URINO trial will fill this gap in knowledge. (C) 2013 Elsevier Ireland Ltd. All rights reserved.</p>

Surgery versus Physiotherapy for Stress Urinary Incontinence

<p>BackgroundPhysiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy.</p><p>MethodsWe performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months.</p><p>ResultsWe randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery.</p><p>ConclusionsFor women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year.</p>