- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653582
Effect of Postural Reeducation Versus Pelvic Floor Muscle Training on Stress Urinary Incontinence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed as a randomized- controlled trial. It will be carried out on women suffering from stress urinary incontinence referred after urology consultations to the Physiotherapy Clinic in Soad Kafafy hospital.
UI, particularly SUI, affects up to 28% of the population and occurs during activities like coughing or sneezing due to inadequate urethral closure pressure. The pelvic floor muscles play a critical role in supporting pelvic organs and maintaining continence. Pelvic floor dysfunction is a significant contributor to SUI. Postural dysfunction can increase mechanical stress and lead to pelvic floor dysfunction. Postural re-education techniques aim to correct imbalances and improve pelvic floor muscle activity, potentially alleviating SUI symptoms by restoring muscle efficiency and enhancing continence.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, MUST University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fifty females with stress urinary incontinence.
- Age of 30-40 years.
- Body mass index (BMI) > 30 kg/m2
Exclusion Criteria:
- Genital prolapse grade 3 or 4 based on Pelvic Organ Prolapse Quantification Classification (POP-Q).
- Overactive bladder (OAB)
- Functional impairment (Barthel scale <85 points).
- Neurological or cognitive impairment (mini mental examination <24 points).
- Any other type of urinary incontinence.
- Pregnancy.
- History of spinal, hip, knee or foot surgery, pelvic and abdominal surgery (including cesarean section)
- Smoking, chronic cough, history of respiratory diseases, osteoporosis (self-reported).
Study Plan
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: Postural reeducation
They will receive a program of postural reeducation with a home program for 12 weeks.
|
The program will include postural awareness, stretching, McKenzie's method, and manual therapy for 12 weeks.
|
|
Experimental: Pelvic floor exercises
They will receive a program of pelvic floor exercises with a home program for 12 weeks.
|
The program will include pelvic floor exercises for 12 weeks.
Three sets of 10 long contractions will be performed, each sustained for 6-8 seconds, three times a day.
After each contraction, participants will be asked to rest for the same period.
Two series of 10 fast contractions will be recommended, consisting of short, quick exercises of 1- to 2-second contractions, followed by long, sustained exercises lasting 5-10 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary incontinence (UI) symptoms
Time Frame: 12 weeks
|
UI symptoms will be measured using a 48-hour Pad Test [14].
This is a standardized test for assessing urine leakage that can be performed at home[15].
Women replace pads as needed over the course of 48 hours.
The results are calculated by subtracting the net weight of used pads from the total weight of non-used pads.
The Pad Test results can be classified as mild (4-20 g), moderate (21-74 g), or severe UI (> 75 g).
|
12 weeks
|
|
Urinary incontinence (UI) impact
Time Frame: 12 weeks
|
It will be assessed using the International Consultation Incontinence Short-Form (ICIQ-UI-SF).
UI impact will be derived from the values of the third question assessing overall impact ("How much does leaking urine interfere with everyday life?", ranging from 0 to 10), with a higher score indicating a greater UI impact.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary incontinence-Quality of life (UI-QoL)
Time Frame: 12 weeks
|
It will be assessed using the International Consultation Incontinence Short-Form (ICIQ-UI-SF).
The UI-QoL will be calculated using the questionnaire's final score (range from 0 to 21), which is the total of the three items, with a higher score indicating more severe UI and a bigger influence on QoL.
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sally Mohamed Saeed, PhD, Lecturer, MUST university
- Principal Investigator: Malak Adel Elmahdy, PhD, Lecturer, Al Hayah University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- P.T.REC/012/005133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stress Urinary Incontinence
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
Hadassah Medical OrganizationCompletedUrinary Stress Incontinence (SI)Israel
-
University Magna GraeciaUnknownStress Urinary IncontinenceItaly
-
University of California, IrvineWithdrawnStress Urinary IncontinenceUnited States
-
Eli Lilly and CompanyBoehringer IngelheimCompleted
-
Eli Lilly and CompanyBoehringer IngelheimCompletedUrinary Stress IncontinenceUnited States
-
GT Urological, LLCCompletedMale Stress Urinary IncontinenceAustralia, Czechia, New Zealand
Clinical Trials on Postural reeducation
-
Cairo UniversityCompletedLow Back Pain, PosturalEgypt
-
University of JaénCompletedFoot Deformities | Hallux Valgus | Hallux DeformitySpain
-
Federal University of BahiaRecruiting
-
Universidade Gama FilhoUnknownLumbar Disc Herniation.Brazil
-
Hopital Charles NicolleCompletedChronic Low Back Pain (CLBP)Tunisia
-
Irmandade da Santa Casa de Misericordia de Sao...CompletedScapular Dyskinesis | CervicalgiaBrazil
-
Universidad Francisco de VitoriaNot yet recruiting
-
Cairo UniversityCompleted
-
University of VigoCompletedMusculoskeletal PainPortugal
-
Riphah International UniversityCompleted