Pelvic Floor Muscle WeaknessRCTNCT07420569
Multimodal Pelvic Floor Rehabilitation in Chronic Stroke Survivors: Long-Term Efficacy, Optimal Protocols, and Adjunctive Therapies for Comprehensive Pelvic Floor Dysfunction.
A study testing 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 and Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. in people with Pelvic Floor Muscle Weakness and Stroke, run by Iqra National University at 1 site in Uganda.
Trial summary
Evaluate long-term efficacy of multimodal PFMT in chronic stroke survivors with PFD. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Stroke
- What is being tested?
- 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 and Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-85; first-ever stroke ≥12 months prior
- Sexual dysfunction per FSFI/IIEF)
- Able to follow two-stage commands.
Who cannot join
- Pre-stroke PFD
- Indwelling catheter
- MoCA <18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Floor Muscle Weakness, Stroke
- Being tested
- 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, Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks.
- Keywords
- Randomised controlled trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called 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.
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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. Receives: 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. Receives: 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™). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oxford scale to determine pelvic floor muscle strength
Primary outcome measure
Measured: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.
Secondary outcomes (1)
Female Sexual Function Index to assess sexual dysfunction in women
standardized tools to aid data collection
Measured: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iqra National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muslim khan, Iqra National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420569
- Sponsor's protocol ID
- INU/REHAB/XC110
- Acronym
- RCT
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical considerations
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07420569
- Acronym / sponsor ID
- RCT / INU/REHAB/XC110
- Conditions
- Pelvic Floor Muscle Weakness, Stroke
- Keywords
- Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Iqra National UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prospective, assessor-blinded, four-arm parallel-group RCT with 1:1:1:1 allocation. | Active comparator | 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/weekProspective, 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) | Active comparator | 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/week3 supervised/week (weeks 1-8), 1/week (9-16) + home. |
| Group B (Intensified PFMT) | Active comparator | 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/week5/week (1-8), 3/week (9-16) + home. |
| Group C (PFMT + Biofeedback) | Active comparator | 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.Standard + vaginal/anal biofeedback (MAPLe®/Peritron™). |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45-85; first-ever stroke ≥12 months prior
- Sexual dysfunction per FSFI/IIEF)
- Able to follow two-stage commands.
Key exclusion criteria (3 listed)
- Pre-stroke PFD
- Indwelling catheter
- MoCA <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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/weekProspective, 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 | 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.Also: 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.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 | Group C (PFMT + Biofeedback) |
Primary outcome
Modified Oxford scale to determine pelvic floor muscle strength
Time frame: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.
Primary outcome measure
1 secondary outcome
Female Sexual Function Index to assess sexual dysfunction in women
Time frame: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Data setLink provided by the sponsor.
- Individual participant dataSharing planned: No. Ethical considerations
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Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Core PFMT: 8-12 contractions (6-10s hold), 3 sets/day, progressed over 16 weeks. in people with Pelvic Floor Muscle Weakness and Stroke, run by Iqra National University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oxford scale to determine pelvic floor muscle strength (time frame: Baseline, 8 weeks, 16 weeks, 6 months, 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.