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

NCT07259148 | Active Not Recruiting

• 1 other identifier: HMEADB-IUU-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.Pelvic floor muscle therapy (PFMT), and
2. 2.Behavioral interventions (bladder training and lifestyle modification).

Conditions

Urgency Urinary Incontinence

Keywords

Urgency urinary incontinence; Overactive bladder; Pelvic floor muscle therapy; Behavioral therapy; Bladder training; Anticholinergic pharmacotherapy; Oxibutinine; Mirabegron; Non-inferiority trial; Women's health

Outcome Measures

Primary Outcomes (1)

• Change in ICIQ-SF Total Score from Baseline to Week 8

  This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score between baseline and week 8. The ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating greater severity.

  Baseline and Week 8

Secondary Outcomes (8)

• Change in ICIQ-LUTSqol Score from Baseline to Week 8

  Baseline and Week 8

• Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours

  Baseline and Week 8

• Patient Global Impression of Improvement (PGI-I) at Week 8

  Week 8

• Change in Number of Micturitions per 24 Hours

  Baseline and Week 8

• Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours

  Baseline and Week 8

Study Arms (2)

Pelvic Floor Muscle Therapy + Pharmacotherapy

ACTIVE COMPARATOR

Supervised pelvic floor muscle training (PFMT) twice weekly for 8 weeks, including slow and fast contractions, posture education, and home exercises. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur.

Behavioral: Pelvic Floor Muscle Training (PFMT); Drug: Oxybutynin / Mirabegron (Standardized Pharmacotherapy)

Behavioral Therapy + Pharmacotherapy

ACTIVE COMPARATOR

Behavioral intervention consisting of bladder training, fluid management, reduction of bladder irritants, sleep hygiene, and healthy lifestyle counseling. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur.

Behavioral: Behavioral Bladder Training Program; Drug: Oxybutynin / Mirabegron (Standardized Pharmacotherapy)

Interventions

Pelvic Floor Muscle Training (PFMT) BEHAVIORAL

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.

Pelvic Floor Muscle Therapy + Pharmacotherapy

Behavioral Bladder Training Program BEHAVIORAL

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.

Behavioral Therapy + Pharmacotherapy

Oxybutynin / Mirabegron (Standardized Pharmacotherapy) DRUG

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.

Behavioral Therapy + Pharmacotherapy; Pelvic Floor Muscle Therapy + Pharmacotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female participants only, due to the epidemiology and pathophysiology of urgency urinary incontinence in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18 years.
• Symptoms of urgency urinary incontinence (UUI) or mixed urinary incontinence with predominance of urgency, with duration ≥3 months.
• Clinical diagnosis of UUI based on history, physical examination, and a 3-day bladder diary.
• Predominance of urgency defined as: at least 50% of total recorded episodes in the bladder diary correspond to urgency (with or without leakage).
• Baseline ICIQ-SF score ≥6.
• Ability to attend scheduled visits and comply with assigned intervention.
• Signed informed consent.

You may not qualify if:

• Pure stress urinary incontinence.
• Mixed urinary incontinence with predominance of stress defined as: more than 70% of episodes in the 3-day bladder diary are triggered by physical effort.
• Symptomatic advanced pelvic organ prolapse (POP-Q stage ≥III).
• Active or recent urinary tract infection (within the last 7 days).
• Prior use of anticholinergics or β3-agonists that cannot be discontinued for a 14-day washout period.
• Pregnancy or breastfeeding.
• Neurological or psychiatric disorders affecting bladder function, record-keeping, or adherence.
• Cognitive or functional difficulty preventing understanding or completion of study procedures.

Sponsors & Collaborators

• Emilio José Dávila Álvarez: lead
• Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños": collaborator

Study Sites (1)

Hospital Militar Escuela Dr. Alejandro Dávila Bolaños

Managua, Managua Department, Nicaragua

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

oxybutynin; mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and statisticians will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator / Principal Investigator

Model Details: Two-arm, parallel-group, randomized controlled trial comparing pelvic floor muscle therapy versus behavioral therapy, both as adjuncts to standardized anticholinergic pharmacotherapy.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: November 22, 2025
• Primary Completion: January 23, 2026
• Study Completion: April 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NI (1)