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Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial
Sponsor: Emilio José Dávila Álvarez
Summary
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.
Official title: Non-Inferiority Randomized Clinical Trial Comparing Behavioral Therapy Plus Pharmacotherapy Versus Pelvic Floor Muscle Training Plus Pharmacotherapy in Women With Urgency Urinary Incontinence
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-11-22
Completion Date
2026-04
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
Pelvic Floor Muscle Training (PFMT)
Supervised pelvic floor muscle training twice weekly for 8 weeks, including 3 sets of slow contractions (6-8 seconds) and 3 sets of fast contractions, posture education, breathing training, and daily home exercises.
Behavioral Bladder Training Program
Structured behavioral program including timed voiding every 2 hours with weekly interval increases, suppression of urgency techniques, fluid optimization, reduction of bladder irritants, sleep hygiene measures, and lifestyle recommendations.
Oxybutynin / Mirabegron (Standardized Pharmacotherapy)
Oxybutynin 5 mg every 12 hours as first-line therapy. Mirabegron 25-50 mg daily will be used in cases of intolerance or inadequate response. Medication use will be monitored and recorded.
Locations (1)
Hospital Militar Escuela Dr. Alejandro Dávila Bolaños
Managua, Managua Department, Nicaragua