Post Menopausal Stress Urinary IncontinenceNCT07322250
The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence
A study testing pelvic floor muscle training -associated EMG-biofeedback. and blood flow restriction in people with Post Menopausal Stress Urinary Incontinence, run by Kafrelsheikh University.
Trial summary
the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Post Menopausal Stress Urinary Incontinence
- What is being tested?
- pelvic floor muscle training -associated EMG-biofeedback. and blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- post-menopausal women, defined by the absence of vaginal bleeding for 12 months,
- body mass index (BMI) < 30
- They should have faced at least two leakage episodes each week and fall into the mild to moderate range of urinary incontinence, measured by (ICIQ-UI SF).
- Two standard questions about stress and urgency UI were used to determine the patient's eligibility.
Who cannot join
- pelvic organ prolapse greater than grade II on Baden-Walker classification system
- previous treatment for UI or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorder, or inability to perform the proposed procedures.
- anyone with past or current injuries to the pelvis, hip joint, or spine, as well as those with uncontrolled diabetes, or those with prior experience in pelvic floor muscle training .
- the presence of uncontrolled hypertension.
- patients with a history of deep venous thrombosis (DVT), varicose Veins, cardiac disease, or lymphedema.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI.
Read the detailed description
We have two groups: control group (A) and experimental group (B) are two matched post-menopausal stress urinary incontinence. Group A will receive PFMT-associated EMG biofeedback, whereas Group B will receive PFMT-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. Our primary outcome measures will be the severity of SUI symptoms, while the secondary outcome measures will involve QOL, self-esteem, patient's global impression of improvement, maximum voluntary isometric contraction (MVIC) of pelvic floor muscles, pelvic floor muscle resting tone, and the endurance of pelvic floor muscles,
- Being tested
- pelvic floor muscle training -associated EMG-biofeedback., blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle training -associated EMG-biofeedback.Other
The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks
blood flow restrictionOther
experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control group will receive Pelvic floor muscle training-associated EMG biofeedback. Receives: Other: pelvic floor muscle training -associated EMG-biofeedback. |
| experimental group | Experimental | experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. Receives: Other: pelvic floor muscle training -associated EMG-biofeedback.; Other: blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of stress urinary incontinence (SUI) symptoms.
severity of SUI symptoms, measured by the Arabic version of the International consultation on incontinence questionnaire-short form (ICIQ-UI SF)
Measured: baseline,10 weeks, 16 weeks
Secondary outcomes (6)
Quality of life (QOL)
QOL will be measured by International consultation on incontinence questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS qol)
Measured: baseline,10 weeks, 16 weeks
self-esteem
self-esteem will be measured by Arabic Rosenberg self-esteem scale
Measured: baseline,10 weeks, 16 weeks
patient's global impression of improvement
patient's global impression of improvement will be measured by Patient Global Impression of Improvement (PGI-I) scale.
Measured: baseline,10 weeks, 16 weeks
maximum voluntary isometric contraction (MVIC) of pelvic floor muscles
maximum voluntary isometric contraction (MVIC) of pelvic floor muscles will be measured by Neurotrac myoplus pro EMG
Measured: baseline,10 weeks, 16 weeks
pelvic floor muscle resting tone
pelvic floor muscle resting tone will be measured by Neurotrac myoplus pro EMG
Measured: baseline,10 weeks, 16 weeks
pelvic floor muscle endurance
pelvic floor muscle endurance will be measured by Neurotrac myoplus pro EMG
Measured: baseline,10 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdiah Mohmmed Altuwjry, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322250
- Sponsor's protocol ID
- KFSIRB200-800
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07322250
- Acronym / sponsor ID
- KFSIRB200-800
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jan 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.
the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI.
Detailed description
We have two groups: control group (A) and experimental group (B) are two matched post-menopausal stress urinary incontinence. Group A will receive PFMT-associated EMG biofeedback, whereas Group B will receive PFMT-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. Our primary outcome measures will be the severity of SUI symptoms, while the secondary outcome measures will involve QOL, self-esteem, patient's global impression of improvement, maximum voluntary isometric contraction (MVIC) of pelvic floor muscles, pelvic floor muscle resting tone, and the endurance of pelvic floor muscles,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: pelvic floor muscle training -associated EMG-biofeedback.Control group will receive Pelvic floor muscle training-associated EMG biofeedback. |
| experimental group | Experimental | Other: pelvic floor muscle training -associated EMG-biofeedback., Other: blood flow restrictionexperimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- post-menopausal women, defined by the absence of vaginal bleeding for 12 months,
- body mass index (BMI) < 30
- They should have faced at least two leakage episodes each week and fall into the mild to moderate range of urinary incontinence, measured by (ICIQ-UI SF).
- Two standard questions about stress and urgency UI were used to determine the patient's eligibility.
Key exclusion criteria (5 listed)
- pelvic organ prolapse greater than grade II on Baden-Walker classification system
- previous treatment for UI or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorder, or inability to perform the proposed procedures.
- anyone with past or current injuries to the pelvis, hip joint, or spine, as well as those with uncontrolled diabetes, or those with prior experience in pelvic floor muscle training .
- the presence of uncontrolled hypertension.
- patients with a history of deep venous thrombosis (DVT), varicose Veins, cardiac disease, or lymphedema.
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 |
|---|---|---|
| pelvic floor muscle training -associated EMG-biofeedback.The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks | Other | control group, experimental group |
| blood flow restrictionexperimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh for 10 weeks. | Other | experimental group |
Primary outcome
severity of stress urinary incontinence (SUI) symptoms.
Time frame: baseline,10 weeks, 16 weeks
severity of SUI symptoms, measured by the Arabic version of the International consultation on incontinence questionnaire-short form (ICIQ-UI SF)
6 secondary outcomes
Quality of life (QOL)
Time frame: baseline,10 weeks, 16 weeks
self-esteem
Time frame: baseline,10 weeks, 16 weeks
patient's global impression of improvement
Time frame: baseline,10 weeks, 16 weeks
maximum voluntary isometric contraction (MVIC) of pelvic floor muscles
Time frame: baseline,10 weeks, 16 weeks
pelvic floor muscle resting tone
Time frame: baseline,10 weeks, 16 weeks
pelvic floor muscle endurance
Time frame: baseline,10 weeks, 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence
Stress Urinary Incontinence
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.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor muscle training -associated EMG-biofeedback. and blood flow restriction in people with Post Menopausal Stress Urinary Incontinence, run by Kafrelsheikh University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jilan Adel, lecturer (01007519909 ext. +2, gelan_youssif@pt.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of stress urinary incontinence (SUI) symptoms. (time frame: baseline,10 weeks, 16 weeks). 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 7 Jan 2026.