Stress Urinary IncontinenceNCT06653582
Effect of Postural Reeducation Versus Pelvic Floor Muscle Training on Stress Urinary Incontinence
A study testing Postural reeducation and Pelvic floor exercises in people with Stress Urinary Incontinence, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the effects of postural reeducation compared to pelvic floor muscle training on urinary incontinence (UI) symptoms, the impact of UI, and quality of life (QoL) in women experiencing stress urinary incontinence (SUI) Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Postural reeducation and Pelvic floor exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2024to 1 Feb 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Fifty females with stress urinary incontinence.
- Age of 30-40 years.
- Body mass index (BMI) > 30 kg/m2
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the effects of postural reeducation compared to pelvic floor muscle training on urinary incontinence (UI) symptoms, the impact of UI, and quality of life (QoL) in women experiencing stress urinary incontinence (SUI)
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Postural reeducation, Pelvic floor exercises
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural reeducationOther
The program will include postural awareness, stretching, McKenzie's method, and manual therapy for 12 weeks.
Pelvic floor exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Postural reeducation | Experimental | They will receive a program of postural reeducation with a home program for 12 weeks. Receives: Other: Postural reeducation |
| Pelvic floor exercises | Experimental | They will receive a program of pelvic floor exercises with a home program for 12 weeks. Receives: Other: Pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence (UI) symptoms
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).
Measured: 12 weeks
Urinary incontinence (UI) impact
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.
Measured: 12 weeks
Secondary outcomes (1)
Urinary incontinence-Quality of life (UI-QoL)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start25 Oct 2024
- Primary completion25 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Mohamed Saeed, Misr University for Science and Technology
- Investigators
- Sally Mohamed Saeed, PhD, Principal investigator, Lecturer, MUST universityMalak Adel Elmahdy, PhD, Principal investigator, Lecturer, Al Hayah university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653582
- Sponsor's protocol ID
- P.T.REC/012/005133
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postural Reeducation Versus Pelvic Floor Muscle Training on Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06653582
- Acronym / sponsor ID
- P.T.REC/012/005133
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 22 Oct 2024 (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.
The purpose of the study is to evaluate the effects of postural reeducation compared to pelvic floor muscle training on urinary incontinence (UI) symptoms, the impact of UI, and quality of life (QoL) in women experiencing stress urinary incontinence (SUI)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural reeducation | Experimental | Other: Postural reeducationThey will receive a program of postural reeducation with a home program for 12 weeks. |
| Pelvic floor exercises | Experimental | Other: Pelvic floor exercisesThey will receive a program of pelvic floor exercises with a home program for 12 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fifty females with stress urinary incontinence.
- Age of 30-40 years.
- Body mass index (BMI) > 30 kg/m2
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Postural reeducationThe program will include postural awareness, stretching, McKenzie's method, and manual therapy for 12 weeks. | Other | Postural reeducation |
| Pelvic floor exercisesThe 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. | Other | Pelvic floor exercises |
Primary outcome
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).
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.
1 secondary outcome
Urinary incontinence-Quality of life (UI-QoL)
Time frame: 12 weeks
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 21 Feb 2025.
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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.
Sally Mohamed Saeed, PhD principal investigator
Lecturer, MUST university
Malak Adel Elmahdy, PhD principal investigator
Lecturer, Al Hayah university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural reeducation and Pelvic floor exercises in people with Stress Urinary Incontinence, run by Misr University for Science and Technology at 1 site in Egypt.
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 8 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 21 Feb 2025. 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 Egypt. 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?
Urinary incontinence (UI) symptoms (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 21 Feb 2025.