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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07420569

Acronym

RCT

Enrollment

140

Registered

2026-02-19

Start date

2022-01-01

Completion date

2025-12-31

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Muscle Weakness, Stroke

Keywords

Randomised controlled trial

Brief summary

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

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.

Interventions

OTHERCore 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.).

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

45 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026