Behavioral Compared With Drug Therapy for Overactive Bladder Symptoms in Parkinson Disease
Bibliographic record
Abstract
Importance: Overactive bladder (OAB) symptoms in Parkinson disease (PD) are burdensome, and the adverse effects of drug treatment can worsen PD-associated morbidity. Drug adverse effects are avoided with pelvic floor muscle exercise-based behavioral therapy. Objective: To assess the noninferiority of behavioral compared with solifenacin drug therapy for OAB symptoms in persons with PD. Design, Setting, and Participants: This 12-week randomized noninferiority trial of behavioral therapy compared with solifenacin was conducted between 2018 and 2023 within 4 US Veterans Affairs health care systems. Eligible participants were diagnosed with PD by a movement disorder neurologist and had an International Consultation on Incontinence Questionnaire OAB module (ICIQ-OAB) symptom score of 7 or higher (range, 0-16; higher score indicates worse symptoms) and Montreal Cognitive Assessment (MOCA) score of 18 or higher (range, 0-30). Participants were randomized 1:1 after stratification by sex, recruitment site, OAB severity, and PD motor symptom severity. Analyses were conducted from October 2023 to April 2024. Interventions: Behavioral therapy was implemented by a nurse practitioner and included pelvic floor muscle training and urge suppression strategies. Solifenacin therapy started at 5 mg daily, with titration to 10 mg daily if needed. Main Outcome and Measures: The primary outcome was the 12-week ICIQ-OAB score across groups within a 15% noninferiority margin. Adverse events were assessed every 2 weeks for 8 weeks and again at 12 weeks. Results: A total of 77 persons with PD (65 [84%] male; mean [SD] age, 71.3 [8.9] years; mean [SD] years with PD, 6.6 [5.8]) were randomized to behavioral (n = 36) or drug therapy (n = 41). Seventy-three participants completed the study (4 dropped out in drug group). Baseline characteristics were balanced across groups, including MOCA score (mean [SD], drug, 23.9 [3.1]; behavioral, 24.8 [3.3]) and ICIQ-OAB score (mean [SD], drug, 9.1 [1.7]; behavioral, 8.5 [1.4]). At 12 weeks postrandomization, ICIQ-OAB scores across groups indicated clinically significant improvement and were within the a priori noninferiority margin of 15% (mean [SD] score, drug, 5.8 [2.4]; behavioral, 5.5 [2.0]; P = .02). Dry mouth and falls were reported more frequently in the drug compared with the behavioral group. Conclusions and Relevance: Results of this randomized noninferiority trial suggest that behavioral therapy is noninferior to drug therapy in improving OAB symptoms in PD. These findings may inform clinical guidelines for urinary symptoms in PD to consider behavioral therapy as an initial treatment option. Trial Registration: ClinicalTrials.gov Identifier: NCT03149809.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".