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Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a
Pierre-Luc Dequirez1, Xavier Biardeau2
1Department of Urology, Claude Huriez Hospital, CHU LILLE, University of Lille, 1 rue Michel Polonovski, 59037, Lille cedex, France. pl.dequirez@icloud.com.
Introduction And Hypothesis:
Using similar methodologies and outcome measures is crucial to allow pertinent literature reviews and meta-analyses. Therefore, this scoping review aims to compare methodologies of randomized clinical trials (RCTs) assessing the efficacy of third-line therapies to treat non-neurogenic OAB: intradetrusor onabotulinumtoxinA (BoNTA) injections, sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS).
Methods:
A literature search was conducted using the PubMed search database. Using filters, the search was limited to RCTs conducted on humans and written in English or French since 2000 which evaluated BoNTA injections, SNM and/or PTNS. RCTs focusing on pediatric or neurogenic OAB were excluded. For each included RCT, methodology was assessed using a standardized form investigating the study design, clinical outcomes and urodynamic outcomes. Inclusion criteria, sex ratio, blinding strategies, treatment arms, primary outcomes and delays for reevaluation were assessed. Availability of clinical and urodynamic outcomes was reported at baseline, 3 months and 6 months.
Results:
Thirty-one RCTs were included in the final synthesis. The most frequent main outcome measure was change in the number of urinary incontinence episodes in 35.5% and in the number of voids per day in 25.8%. Bladder diaries were lacking in 12.9%, 32.3% and 80.1% at baseline, 3 and 6 months, respectively, while 26% of studies reported the results of urodynamic studies at any point.
Conclusion:
Heterogeneity in study designs and data collection was pointed out between RCTs assessing the efficacy of third-line therapies to treat non-neurogenic OAB. We therefore advocate for the development of specific research guidelines focusing on OAB-related therapies.
Insights
Methodological inconsistencies in randomized clinical trials (RCTs) for overactive bladder (OAB) treatments like onabotulinumtoxinA, SNM, and PTNS hinder reviews. Developing research guidelines for OAB therapies is recommended.
Area of Science:
- Urology
- Clinical Research Methodology
Background:
- Standardized methodologies and outcome measures are essential for effective literature reviews and meta-analyses in clinical research.
- Non-neurogenic overactive bladder (OAB) is a condition often treated with third-line therapies, including intradetrusor onabotulinumtoxinA (BoNTA) injections, sacral neuromodulation (SNM), and posterior tibial nerve stimulation (PTNS).
Purpose of the Study:
- To conduct a scoping review comparing the methodologies of randomized clinical trials (RCTs) that evaluate the efficacy of third-line therapies for non-neurogenic OAB.
- To identify inconsistencies in study designs and data collection across RCTs assessing BoNTA, SNM, and PTNS for OAB treatment.
Main Methods:
- A comprehensive literature search was performed on the PubMed database, focusing on RCTs published in English or French since 2000.
- Included RCTs evaluated BoNTA injections, SNM, and/or PTNS for non-neurogenic OAB, excluding pediatric or neurogenic cases.
- Methodologies were assessed using a standardized form, examining study design, clinical and urodynamic outcomes, inclusion criteria, blinding strategies, treatment arms, primary outcomes, and follow-up durations.
Main Results:
- Thirty-one RCTs were included in the final analysis.
- The most common primary outcome measures were changes in urinary incontinence episodes (35.5%) and daily voiding frequency (25.8%).
- Significant heterogeneity was observed in data collection, with bladder diaries missing in a substantial percentage of studies at 3 and 6 months (32.3% and 80.1%, respectively), and only 26% reporting urodynamic study results.
Conclusions:
- There is considerable heterogeneity in study designs and data collection methods among RCTs evaluating third-line therapies for non-neurogenic OAB.
- The findings highlight the need for the development of specific research guidelines to standardize OAB-related therapy trials.
- Standardization will facilitate more robust literature reviews and meta-analyses, ultimately improving evidence-based treatment strategies for OAB.
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