TOPLINE:
Structured behavioral therapy focused on pelvic floor muscle exercise was noninferior to treatment with solifenacin for alleviating overactive bladder symptoms in patients with Parkinson’s disease (PD), new research showed. As it was also associated with fewer side effects, especially falls, researchers recommended the behavioral therapy as a first-line treatment option.
METHODOLOGY:
- This 12-week randomized noninferiority trial was conducted between 2018 and 2023 within four Veterans Affairs healthcare systems in the US.
- Overall, 77 patients diagnosed with PD and overactive bladder symptoms, as measured with an International Consultation on Incontinence Questionnaire overactive bladder module (ICIQ-OAB) symptom score ≥ 7, were included.
- All participants (mean age, 71 years; 84% men; 90% White individuals) were randomly assigned to receive either pelvic floor muscle exercise-based behavioral therapy with urge-suppression training (n = 36) or 5 mg solifenacin daily with need-based titration up to 10 mg daily (n = 41).
- The primary outcome was ICIQ-OAB symptom score at 12 weeks. Secondary outcomes were ICIQ-OAB bother and quality of life scores and drug-related adverse events.
TAKEAWAY:
- At 12 weeks, clinically significant improvement in ICIQ-OAB scores was observed across both treatment groups within a noninferiority margin of 15% (drug vs behavioral therapy: mean ICIQ-OAB score, 5.8 vs 5.5; P = .02).
- Both groups also had a reduction in symptom frequency, which was associated with a reduction in bother scores and an improvement in overactive bladder-related quality of life.
- Compared with the behavioral therapy group, the solifenacin group had a greater number of adverse events, including dry mouth (P = .002) and pain or burning during urination (P = .03). They also had a greater number of falls (6 vs 0).
IN PRACTICE:
“The finding of increased falls in the solifenacin therapy group reinforces the need to carefully consider the risk-benefit ratio of medications for urinary symptoms, especially given the increased risk of falls among persons with PD. Results of this study suggest that behavioral therapy is an effective treatment option for persons with PD,” the investigators wrote.
SOURCE:
The study was led by Camille P. Vaughan, MD, Division of Geriatrics and Gerontology in the Department of Medicine, Emory University, Atlanta. It was published online on July 14 in JAMA Neurology.
LIMITATIONS:
The follow-up duration was limited to 12 weeks, restricting insight into longer-term outcomes. The cohort predominantly had male participants, reducing the generalizability of the findings, and the study relied on patient-reported data. Additionally, a higher dropout in the drug group led to nonrandom missing data, potentially biasing comparisons.
DISCLOSURES:
The study was funded by a grant from Veterans Affairs Rehabilitation Research and Development. Two investigators reported receiving grants from various sources during the conduct of the study. The other nine investigators reported having no relevant financial relationships.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.