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

N/ACompletedNCT07420569

Iqra National University140 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Pelvic Floor Muscle Weakness Stroke

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/weekOTHER

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IQRA University

Kampala, Uganda

Outcomes

Primary Outcomes

Modified Oxford scale to determine pelvic floor muscle strength

Primary outcome measure

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

Secondary Outcomes

Female Sexual Function Index to assess sexual dysfunction in women

standardized tools to aid data collection

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

Data from ClinicalTrials.gov

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