Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial

Urgency urinary incontinence (UUI) is a common condition that significantly affects women's quality of life. Pharmacotherapy is often used as first-line treatment, but its effectiveness can be limited unless combined with non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) is widely recommended; however, access to specialized physiotherapy services is limited in many low-resource settings such as Nicaragua. Behavioral interventions-including bladder training, fluid control, avoidance of bladder irritants, and sleep-hygiene strategies-represent a low-cost alternative, but direct comparative evidence against PFMT is limited. This randomized, controlled, non-inferiority clinical trial will compare two adjuvant strategies combined with standard anticholinergic pharmacotherapy (oxibutinine): 1. Pelvic floor muscle therapy (PFMT), and 2. Behavioral interventions (bladder training and lifestyle modification). Eighty adult women with urgency urinary incontinence or mixed incontinence with urgency-predominance will be randomized 1:1. The intervention period is 8 weeks, with assessments at baseline, week 4, week 8, and an exploratory follow-up at week 12. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to week 8. A non-inferiority margin of 3 points will be applied. Secondary outcomes include episodes of urgency/incontinence per 24 h, ICIQ-LUTSqol scores, patient-reported global improvement (PGI-I), adherence, and adverse events. This study aims to determine whether behavioral interventions are not inferior to PFMT as adjuncts to pharmacotherapy, potentially offering a feasible and more accessible therapeutic alternative for women with UUI in resource-limited healthcare environments.

NCT Number	NCT07259148
Lead Sponsor	Emilio José Dávila Álvarez Collaborators: Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"
Conditions	Urgency Urinary Incontinence
Enrollment	80 participants
Start Date	2025-11-22
Primary Completion	2026-01-23 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2026-01-26