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The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence

The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07322250
Enrollment
60
Registered
2026-01-07
Start date
2025-12-30
Completion date
2026-06-30
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Menopausal Stress Urinary Incontinence

Brief summary

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,

Interventions

OTHERpelvic floor muscle training -associated EMG-biofeedback.

The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks

OTHERblood flow restriction

experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh for 10 weeks.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. post-menopausal women, defined by the absence of vaginal bleeding for 12 months, 2. body mass index (BMI) \< 30 3. 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). 4. Two standard questions about stress and urgency UI were used to determine the patient's eligibility.

Exclusion criteria

1. pelvic organ prolapse greater than grade II on Baden-Walker classification system 2. previous treatment for UI or hormone therapy, ongoing urinary tract infections, cognitive or neurological disorder, or inability to perform the proposed procedures. 3. 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 . 4. the presence of uncontrolled hypertension. 5. patients with a history of deep venous thrombosis (DVT), varicose Veins, cardiac disease, or lymphedema.

Design outcomes

Primary

MeasureTime frameDescription
severity of stress urinary incontinence (SUI) symptoms.baseline,10 weeks, 16 weeksseverity of SUI symptoms, measured by the Arabic version of the International consultation on incontinence questionnaire-short form (ICIQ-UI SF)

Secondary

MeasureTime frameDescription
self-esteembaseline,10 weeks, 16 weeksself-esteem will be measured by Arabic Rosenberg self-esteem scale
patient's global impression of improvementbaseline,10 weeks, 16 weekspatient's global impression of improvement will be measured by Patient Global Impression of Improvement (PGI-I) scale.
Quality of life (QOL)baseline,10 weeks, 16 weeksQOL will be measured by International consultation on incontinence questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS qol)
pelvic floor muscle resting tonebaseline,10 weeks, 16 weekspelvic floor muscle resting tone will be measured by Neurotrac myoplus pro EMG
pelvic floor muscle endurancebaseline,10 weeks, 16 weekspelvic floor muscle endurance will be measured by Neurotrac myoplus pro EMG
maximum voluntary isometric contraction (MVIC) of pelvic floor musclesbaseline,10 weeks, 16 weeksmaximum voluntary isometric contraction (MVIC) of pelvic floor muscles will be measured by Neurotrac myoplus pro EMG

Contacts

Primary ContactJilan Adel, lecturer
gelan_youssif@pt.kfs.edu.eg01007519909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026