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Completed

NCT Number: NCT07420569

Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction.

Evaluate long-term efficacy of multimodal PFMT in chronic stroke survivors with PFD.

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Key information

Conditions

Pelvic Floor Muscle Weakness Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IQRA University

Kampala, Uganda

About this study

Stroke is a leading cause of disability, with pelvic floor dysfunction (PFD) affecting 25-79% of survivors, including urinary incontinence, fecal incontinence/constipation, and sexual dysfunction. Evidence gaps include long-term efficacy (>12 months), optimal PFMT protocols, adjunctive therapies (biofeedback, NMES), bowel/sexual domains, partner impacts, QoL correlations, and prognostic factors. This trial addresses these via a large-scale, multicenter RCT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45-85; first-ever stroke ≥12 months prior
  • Sexual dysfunction per FSFI/IIEF)
  • Able to follow two-stage commands.

Exclusion criteria

  • Pre-stroke PFD
  • Indwelling catheter
  • MoCA <18

Treatment and study plan

Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. • Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home. • Group B (Intensified PFMT): 5/week

Other

Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. Duration: 16 weeks supervised

+ 36 weeks home maintenance (total 12 months follow-up). Setting: Eight rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care & Rehabilitation Center, Al-Makki Rehabilitation Center, etc.).

Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.

Other

Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. Duration: 16 weeks supervised

+ 36 weeks home maintenance (total 12 months follow-up). Setting: Eight rehabilitation centers in Pakistan (e.g., Swat Psychiatric Care & Rehabilitation Center, Al-Makki Rehabilitation Center, etc.).

Other names: Group A (Standard PFMT): 3 supervised/week (weeks 1-8), 1/week (9-16) + home, Group B (Intensified PFMT): 5/week (1-8), 3/week (9-16) + home., Group C (PFMT + Biofeedback): Standard + vaginal/anal biofeedback (MAPLe®/Peritron™), Group D (PFMT + NMES): Standard + NMES (20 Hz, 300μs, 20 min, 3x/week). Weeks 17-52: Home maintenance with monthly coaching.

Primary outcomes

  1. Modified Oxford scale to determine pelvic floor muscle strength

    Time frame: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

    Primary outcome measure

Secondary outcomes

  1. Female Sexual Function Index to assess sexual dysfunction in women

    Time frame: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

    standardized tools to aid data collection

Sponsors and collaborators

Lead sponsor

Iqra National University

Other

Registry information

Official study title

Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction - A Multicenter Randomized Controlled Trial

Acronym: RCT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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