A systematic review on outcome reporting in randomised controlled trials on surgical interventions for female stress urinary incontinence: a call to develop a core outcome set.

BACKGROUND: Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence. OBJECTIVES: Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI. SEARCH STRATEGY: Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE. SELECTION CRITERIA: Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed the included studies and documented outcomes. MAIN RESULTS: Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (ß = 0.538, P < 0.001; ß = 0.218, P = 0.011, respectively). CONCLUSIONS: Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success rate - complete cure, partial improvement, or failure of response; urodynamic evaluation outcomes - overactive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomes - quality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures. TWEETABLE ABSTRACT: There is significant variation in outcome reporting in SUI trials. Our systematic review findings aim to form the basis for the development of a core outcome set.

Intravesical treatment of painful bladder syndrome: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to assess the effectiveness of intravesical treatment for painful bladder syndrome (PBS). METHODS: A systematic review was performed until December 31, 2010. The selection criteria included only randomized controlled trials of PBS patients who received intravesical treatment. The primary outcomes measures were clinical and urodynamic parameters. Relative risk and mean differences were used for binary and continuous outcomes respectively, with confidence interval of 95%. RESULTS: The search strategy identified 770; however, only 28 eligible trials met methodological requirements for complete analysis. Altogether, the review included four treatment modalities: resiniferatoxin, Bacillus Calmette-Guérin (BCG), oxybutynin, and alkalinized lidocaine. Meta-analysis of BCG therapy showed improvement in symptoms according to the Wisconsin Interstitial Cystitis Symptom Inventory, but no difference in 24-h urinary frequency. CONCLUSIONS: Meta-analysis showed an improvement exclusively of the symptoms as measured by the Wisconsin Interstitial Cystitis Inventory, but not in 24-h urinary frequency, with BCG therapy. Further randomized clinical trials, including trials of more recent drugs, are required for evaluation of intravesical therapies for PBS.

Urinary tract infections in pregnant women.

Urinary tract infections are of great importance during pregnancy owing to undesirable complications such as fetal and maternal morbidity. This paper describes the functional alterations that occur in this condition and predispose to infection. Clinical presentation and subsidiary diagnosis are discussed, including asymptomatic bacteriuria, cystitis and pyelonephritis. In addition, the authors report drug options, and their safety and duration of treatment during pregnancy.