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

NCT07420569 | Completed DMC

• 1 other identifier: INU/REHAB/XC110
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Floor Muscle Weakness; Stroke

Keywords

Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Modified Oxford scale to determine pelvic floor muscle strength

  Primary outcome measure

  Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

Secondary Outcomes (1)

• Female Sexual Function Index to assess sexual dysfunction in women

  Baseline, 8 weeks, 16 weeks, 6 months, 12 months.

Study Arms (4)

Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.

ACTIVE COMPARATOR

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

Group A (Standard PFMT)

ACTIVE COMPARATOR

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

Group B (Intensified PFMT)

ACTIVE COMPARATOR

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

Group C (PFMT + Biofeedback)

ACTIVE COMPARATOR

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

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 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.).

Group A (Standard PFMT); Group B (Intensified PFMT); Group C (PFMT + Biofeedback); Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation.

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.).

Also known as: 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.

Group C (PFMT + Biofeedback)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Iqra National University: lead

Study Sites (1)

IQRA University

Kampala, Uganda

Location

Related Links

• Data set

MeSH Terms

Conditions

Stroke

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: January 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)