- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337278
Posturography Rehabilitation and Pelvic Floor Training on Urinary Incontinence in Women
January 1, 2026 updated by: Khaoula Mestour, Mohammed V University in Rabat
Effect of Lumbopelvic Rehabilitation Using Posturography Combined With Pelvic Floor Training on Urinary Incontinence in Women
The goal of this clinical trial is to evaluate whether lumbopelvic postural rehabilitation combined with pelvic floor muscle training (PFMT) is more effective than PFMT alone in women with urinary incontinence. The main questions it aims to answer are:
- Does the addition of lumbopelvic postural rehabilitation improve the severity of urinary incontinence as measured by the ICIQ-UI-SF questionnaire?
- Does it improve urinary symptom profile, pelvic floor muscle strength, patient-reported overall improvement, and quality of life compared to PFMT alone?
Participants will be randomly assigned to one of two groups:
- Experimental group (Group A): PFMT (3 sessions/week) plus lumbopelvic postural rehabilitation (2 sessions/week) for 12 weeks.
- Control group (Group B): PFMT alone (3 sessions/week) for 12 weeks. Participants will perform pelvic floor exercises in supine and seated positions, with supervised sessions at the hospital and home exercises. Postural rehabilitation includes stability and mobility exercises for the lumbopelvic region using Posturography. Outcomes will be assessed at baseline, at 6 weeks, and at 12 weeks.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Khaoula Mestour
- Phone Number: +212 6 17 70 82 62
- Email: khaoulamestour00@gmail.com
Study Locations
-
-
Rabat-Salé-Kénitra
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Rabat, Rabat-Salé-Kénitra, Morocco, 10000
- Recruiting
- Al Ayachi Hospital, CHU Ibn Sina
-
Contact:
- Khaoula Mestour
- Phone Number: +212 6 17 70 82 62
- Email: khaoulamestour00@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female participants aged between 18 and 65 years
- Presence of clinical signs of urinary incontinence (stress urinary incontinence and/or urge urinary incontinence and/or mixed urinary incontinence) diagnosed according to the International Continence Society (ICS) terminology
- USP (urinary symptom profile) scores for stress urinary incontinence and/or overactive bladder ≥ 1
- Normal neuro-perineal examination
- Written informed consent provided prior to participation in the study
Exclusion Criteria:
- Known detrusor overactivity or reduced bladder compliance of neurological origin
- Associated voiding dysfunction, defined as a Urinary Symptom Profile (USP) dysuria subscale score ≥ 1
- Known organic or morphological pathology of the lower urinary tract
- Pelvic organ prolapse grade II or higher according to the Pelvic Organ Prolapse Quantification system (POP-Q)
- Current urinary tract infection or vaginal infection
- Cognitive or visual impairments that may interfere with understanding or performing the exercise program
- Pregnant women or women within 10 months postpartum
- Anticholinergic medication use or hormone replacement therapy within the last 6 months
- Recent pelvic or abdominal surgery within the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined Pelvic Floor Muscle Training and Posturography Rehabilitation
Participants receive pelvic floor muscle training combined with lumbopelvic rehabilitation using posturography for a total duration of 12 weeks.
|
Pelvic floor training consists of voluntary contractions of the pelvic floor muscles, using short, rapid contractions combined with slow, sustained contractions, aimed at improving strength and endurance.
Training is performed in supine and seated positions, with one supervised session per week at the hospital and three home sessions per week, over a total duration of 12 weeks.
Postural rehabilitation consists of seated exercises focusing on stability and mobility of the lumbopelvic region, using posturography.
Sessions last 30 minutes, conducted twice weekly, over a total duration of 12 weeks.
|
|
Active Comparator: Pelvic Floor Muscle Training Alone
Participants receive pelvic floor muscle training alone for a total duration of 12 weeks.
|
Pelvic floor training consists of voluntary contractions of the pelvic floor muscles, using short, rapid contractions combined with slow, sustained contractions, aimed at improving strength and endurance.
Training is performed in supine and seated positions, with one supervised session per week at the hospital and three home sessions per week, over a total duration of 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Time Frame: 6 weeks and 12 weeks from start of intervention
|
The primary outcome is the severity of urinary incontinence measured by the ICIQ-UI-SF.
This validated questionnaire assesses frequency, quantity, and impact of leaks on quality of life.
The overall score is obtained by adding up the 3 questions, ranging from 0 to 21, with a higher score indicating more severe symptoms.
|
6 weeks and 12 weeks from start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
Time Frame: 6 weeks and 12 weeks from start of intervention
|
PGI-I is a patient-reported questionnaire assessing overall improvement in urinary symptoms compared to baseline.
Scores range from "considerably improved" to "considerably worsened".
|
6 weeks and 12 weeks from start of intervention
|
|
Urinary Symptom Profile (USP) scores
Time Frame: 6 weeks and 12 weeks from start of intervention
|
questionnaire enabling qualitative and quantitative analysis of urinary symptoms of stress urinary incontinence, overactive bladder, and dysuria.
We used the subscores for stress urinary incontinence and overactive bladder.
|
6 weeks and 12 weeks from start of intervention
|
|
Pelvic Floor Muscle Strength (Modified Oxford Scale)
Time Frame: 6 weeks and 12 weeks from start of intervention
|
The modified Oxford scale assesses pelvic floor muscle strength through vaginal palpation and visual observation during maximum voluntary contraction.
The classification ranges from 0 (no contraction) to 5 (strong contraction)
|
6 weeks and 12 weeks from start of intervention
|
|
Incontinence Impact Questionnaire - Short Form (IIQ-7)
Time Frame: 6 weeks and 12 weeks from start of intervention
|
IIQ-7 measures the impact of urinary incontinence on daily activities, social relationships, mobility, and emotional health.
Each item is scored from 0 (not at all) to 3 (greatly), with higher total scores indicating greater impact.
|
6 weeks and 12 weeks from start of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2025
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
January 1, 2026
First Submitted That Met QC Criteria
January 1, 2026
First Posted (Actual)
January 13, 2026
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 1, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
Other Study ID Numbers
- UM5-MPR-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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