Vaginal cone use in passive and active phases in patients with stress urinary incontinence

OBJECTIVE: To evaluate vaginal cone therapy in two phases, passive and active, in women with stress urinary incontinence. METHODS: A prospective study was conducted at the Department of Obstetrics and Gynecology, São Paulo University, Brazil. Twenty-four women with a clinical and urodynamic diagnosis of stress urinary incontinence were treated with vaginal cones in a passive phase (without voluntary contractions of the pelvic floor) and an active phase (with voluntary contractions), each of which lasted three months. Clinical complaints, a functional evaluation of the pelvic floor, a pad test, and bladder neck mobility were analyzed before and after each phase. RESULTS: Twenty-one patients completed the treatment. The reduction in absolute risk with the pad test was 0.38 (p<0.034) at the end of the passive phase and 0.67 (p<0.0001) at the end of the active phase. The reduction in absolute risk with the pelvic floor evaluation was 0.62 (p<0.0001) at the end of the passive phase and 0.77 (p<0.0001) at the end of the active phase. The reduction in absolute risk of bladder neck mobility was 0.38 (p<0.0089) at the end of the passive phase and 0.52 (p<0.0005) at the end of the active phase. Complete reversal of symptomatology was observed in 12 (57.1%) patients, and satisfaction was expressed by 19 (90.4%). CONCLUSION: Using vaginal cones in the passive phase, as other researchers did, was effective. Inclusion of the active phase led to additional improvement in all of the study parameters evaluated in women with stress urinary incontinence. Randomized studies are needed, however, to confirm these results

The efficacy and safety of urethral injection therapy for urinary incontinence in women: a systematic review

To evaluate the efficacy and safety of different bulking agents for treating urinary incontinence in women, a systematic review including only randomized controlled trials was performed. The subjects were women with urinary incontinence. The primary outcomes were clinical and urodynamic parameters. The results were presented as a weighted mean difference for non-continuous variables and as relative risk for continuous variables, both with 95% confidence intervals. Initially, 942 studies were identified. However, only fourteen eligible trials fulfilled the prerequisites. Altogether, the review included 1814 patients in trials of eight different types of bulking agents, and all studies were described and analyzed. The measured outcomes were evaluated using a large variety of instruments. The most common complications of the bulking agents were urinary retention and urinary tract infection. Additionally, there were certain major complications, such as one case of death after use of autologous fat. However, the lack of adequate studies, the heterogeneous populations studied, the wide variety of materials used and the lack of long-term follow-up limit guidance of practice. To determine which substance is the most suitable, there is a need for more randomized clinical trials that compare existing bulking agents based on standardized clinical outcomes

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment

OBJECTIVE: To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance. METHODS: This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. They underwent 12 sessions of 30-min TENS application and were assigned to five groups: one leg, once a week (n=26); one leg, twice a week (n=27); two legs, once a week (n=26); two legs, twice a week (n=28); and placebo (n=30). Symptoms of overactive bladder and its impact on quality of life were evaluated before and after 6 or 12 weeks of treatment using the Overactive Bladder Questionnaire-V8 and voiding diary. ClinicalTrials.gov: NCT01912885. RESULTS: The use of one leg, once a week TENS application reduced the frequency of urgency episodes compared with the placebo (1.0±1.6 vs. 1.4±1.9; p=0.046) and frequency of incontinence episodes compared with the placebo (0.7±1.4 vs.1.4±2.2; p&lt;0.0001). The one-leg, twice a week protocol decreased the urinary frequency compared with the two legs, once a week protocol (8.2±3.5 vs. 9.0±5.1; p=0.026) and placebo (8.2±3.5 vs. 7.9±2.7; p=0.02). Nocturia improved using the two legs, once a week protocol (1.5±1.8) when compared with the one leg, twice a week protocol (1.9±2.0) and placebo (1.7±1.6) (p=0.005 and p=0.027, respectively). Nocturia also improved using the two legs, twice a week protocol when compared with the one leg, twice a week protocol (1.3±1.2 vs.1.9±2.0; p=0.011). CONCLUSION: One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia

A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research

Background More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. Methods An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on ‘core’ outcomes. Discussion Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development

A meta‐synthesis of qualitative studies on stress urinary incontinence in women for the development of a Core Outcome Set: A systematic review

Objective: Given the high variation of perceptions of women with stress urinary incontinence (SUI), qualitative meta-synthesis in this field appears warranted. We aimed to synthesize evidence on women's experiences of SUI by analyzing qualitative data. Methods: A literature search of Medline, Embase, Scopus, PsycInfo, and CINAHL databases was performed by a CHORUS Working Group, from inception to August 2020. Qualitative studies on women's perspectives on SUI were included. Thematic analysis was used as a conceptual approach to analyze the data and develop a set of overarching themes. The quality of studies was assessed based on the Critical Appraisal Skills Program tool. Results: Seven studies were included. Six themes encompassing women's perspectives on SUI emerged: experiencing SUI, awareness of SUI, treatments for SUI, sexuality, communication, and psychosocial effects. The quality appraisal of the studies showed good coherence. Conclusion: This study revealed six overarching themes, of which treatment had the highest prevalence. Assessment of women's perceptions of SUI in the context of a qualitative meta-synthesis may inform policy and practice around this condition, may guide and help set research priorities, and will ideally contribute to the development of a Core Outcome Set for SUI. Keywords: Core Outcome Set; bias assessment; female; meta-synthesis; patients’ perspectives; pelvic floor disorders; qualitative study; stress urinary incontinence; systematic review