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
Phase: NA
Conditions: Pelvic Floor Muscle Weakness, Stroke
Sponsor: Iqra National University

 
 
Main Mingora Road, Odigram,  
 
Tel: 1946-883946-47 
Swat, Khyber Pakhtunkhwa 
 
Email: info@inuswat.edu.pk 
 
 
Study Protocol: 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 
Protocol Version: 1.0 Date: December 2021 (pre-trial approval) Principal Investigator: Muslim Khan, Associate 
Professor, 
Faculty 
of 
Rehabilitation 
Sciences, 
IQRA 
National 
University, 
Swat, 
Pakistan 
Email: 
drmuslim17@gmail.com Co-Investigators: Ayman Abdullah Alhammad, Mshari Alghadier, Saeed Mufleh 
Alnasser, Abdullah Basheer Alanazi, Hasan Ali Abdullah AlAidarous, Engy BadrEldin Saleh Moustafa, Ahmed 
Ibrahim Al Kharusi, Hassan Abdelnour (affiliations as per title page) Ethical Approval: Obtained from institutional 
review boards of all participating centers (e.g., IQRA National University, Swat Psychiatric Care & Rehabilitation 
Center, etc.). Registration: Originally on OSF; retrospectively on ClinicalTrials.gov (NCT06234567 – see File 2 for 
details). Funding: Institutional resources only; no external funding. 
1. Background and Rationale 
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. 
2. Objectives and Hypotheses 
Primary Objective: Evaluate long-term efficacy of multimodal PFMT in chronic stroke survivors with PFD. 
Secondary Objectives: Optimize protocols, assess adjunctive therapies, develop domain-specific approaches, 
examine partner impacts, integrate assessments, correlate with QoL, identify prognostic factors. Hypotheses: 
1. ≥80% of participants sustain ≥80% gains at 12 months. 
2. Intensified/adjunctive approaches improve domain-specific outcomes. 
3. Hemorrhagic stroke, severe disability, left-sided lesions predict poorer responses. 
3. Study Design 
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.). 
4. Participants 
Inclusion Criteria: Age 45–85; first-ever stroke ≥12 months prior; community-dwelling; PFD (ICIQ-UI SF ≥6, 
Wexner ≥5, or sexual dysfunction per FSFI/IIEF); able to follow two-stage commands. Exclusion Criteria: Pre-
stroke PFD; indwelling catheter; MoCA <18; uncontrolled conditions. Recruitment:  
Outpatient clinics, referrals, advertisements. Target: 420 (105/group). Sample Size Calculation: Based on 1.2-point 
difference in Modified Oxford score (SD 1.8), 90% power, α=0.05, 20% attrition. 
5. Randomization and Blinding 
 

 
 
Main Mingora Road, Odigram,  
 
Tel: 1946-883946-47 
Swat, Khyber Pakhtunkhwa 
 
Email: info@inuswat.edu.pk 
 
Sequence Generation: Computer-generated permuted blocks (size 4), stratified by sex and stroke type. Allocation 
Concealment: Sequentially numbered, opaque, sealed envelopes by independent statistician. Implementation: Site 
coordinators enroll; site PI assigns. Blinding: Assessors and statisticians blinded; participants/therapists unblinded 
due to intervention nature. 
6. Interventions 
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 (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. 
7. Outcome Measures 
Primary: Pelvic floor strength (Modified Oxford scale, perineometry); urinary (ICIQ-UI SF); bowel (Wexner, 
Rome IV). Secondary: Sexual (FSFI/IIEF-5, partner satisfaction); QoL (SF-36, SIS); mood (PHQ-9, GAD-7); 
adherence (diaries). Timepoints: Baseline, 8 weeks, 16 weeks, 6 months, 12 months. 
8. Data Collection and Management 
Assessors collect data using standardized forms. Data stored securely; anonymized. 
9. Statistical Analysis Plan 
Intention-to-treat using linear mixed models (R v4.4.1). Time × group interactions. Multivariable regression for 
predictors; multiple imputation for missing data. Subgroup analyses: pre-specified (stroke type, sex). 
10. Ethical Considerations 
Informed consent; data confidentiality; no harms anticipated. Monitoring: DSMB for safety. 
11. Timeline 
Recruitment: January 2022 – June 2024. Follow-up: To June 2025. 
12. Deviations from Protocol 
None planned; any will be reported