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

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.

Conditions

• Urgency Urinary Incontinence

Interventions

BEHAVIORAL

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

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.

DRUG

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.

Sponsors & Collaborators

• Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"

  collaborator OTHER

• Emilio José Dávila Álvarez

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-22

Primary Completion

2026-01-23

Completion

2026-04-30

Countries

• Nicaragua

Study Locations