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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Pelvic Floor Muscle Weakness
• Intervention / Treatment: Other: 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: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • IQRA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.; 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: 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; 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.).
Active Comparator: Group A (Standard PFMT); 3 supervised/week (weeks 1-8), 1/week (9-16) + home.	Other: 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; 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.).
Active Comparator: Group B (Intensified PFMT); 5/week (1-8), 3/week (9-16) + home.	Other: 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; 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.).
Active Comparator: Group C (PFMT + Biofeedback); Standard + vaginal/anal biofeedback (MAPLe®/Peritron™).	Other: 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; 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: Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Oxford scale to determine pelvic floor muscle strength	Primary outcome measure	Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index to assess sexual dysfunction in women	standardized tools to aid data collection	Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

Collaborators and Investigators

• Sponsor: Iqra National University

Publications and helpful links

Helpful Links

• Data set

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomised controlled trial
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Nursing Services; Home Care Services
• Other Study ID Numbers: INU/REHAB/XC110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Ethical considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No