Adverse Events Associated with Nonsurgical Treatments for Urinary Incontinence in Women: a Systematic Review
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Urinary incontinence (UI) is a common malady in women. Numerous nonsurgical treatments are available, each associated with risk of adverse events (AEs).
We systematically reviewed nonsurgical interventions for urgency, stress, or mixed UI in women, focusing on AEs. We searched MEDLINE®, Cochrane Central Trials Registry, Cochrane Database of Systematic Reviews, and Embase® through December 4, 2017. We included comparative studies and single-group studies with at least 50 women. Abstracts were screened independently in duplicate. One researcher extracted study characteristics and results with verification by another independent researcher. When at least four studies of a given intervention reported the same AE, we conducted random effects model meta-analyses of proportions. We also assessed the strength of evidence.
There is low strength of evidence that AEs are rare with behavioral therapies and neuromodulation, and that periurethral bulking agents may result in erosion and increase the risk of voiding dysfunction. High strength of evidence finds that anticholinergics and alpha agonists are associated with high rates of dry mouth and constitutional effects such as fatigue and gastrointestinal complaints. Onabotulinum toxin A (BTX) is also associated with increased risk of urinary tract infections (UTIs) and voiding dysfunction (moderate strength of evidence).
Behavioral therapies and neuromodulation have low risk of AEs. Anticholinergics and alpha agonists have high rates of dry mouth and constitutional effects. BTX is associated with UTIs and voiding dysfunction. Periurethral bulking agents are associated with erosion and voiding dysfunction. These AEs should be considered when selecting appropriate UI treatment options. AE reporting is inconsistent and AE rates across studies tended to vary widely. Trials should report AEs more consistently.
KEY WORDSurinary incontinence quality of life adverse events systematic review meta-analysis
This report is based on research conducted by the Brown Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00002-I). The Patient Centered Outcomes Research Institute (PCORI) funded the report (PCORI Publication No. 2018-SR-03). The authors gratefully acknowledge the contribution of Aysegul Gozu, MD, MPH, our AHRQ Task Order Officer; Jennifer Croswell, MD, MPH, our PCORI Senior Program Officer; and Kimberly Bailey, MS, our PCORI Program Officer. We would also like to thank and acknowledge the additional research associates and other staff who helped to conduct this systematic review: Valerie Rofeberg, ScM, Georgios Markozannes, MSc, Hannah Kimmel, MPH, Iman Saeed, ScM, Mengyang Di, PhD, Gowri Raman, MBBS, MS, Esther Avendano, MS, Andrew Zullo, PharmD, PhD, Jenni Quiroz, BS, and Anya Wallack, PhD.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they do not have a conflict of interest.
The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ or PCORI. Therefore, no statement in this report should be construed as an official position of PCORI, AHRQ, or of the U.S. Department of Health and Human Services.
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