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

the purpose of the study is to investigate the effect of blood flow restriction training on postmenopausal SUI.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Menopausal Stress Urinary Incontinence
• Intervention / Treatment: Other: pelvic floor muscle training -associated EMG-biofeedback.; Other: blood flow restriction

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jilan Adel, lecturer; Phone Number: +2 01007519909; Email: gelan_youssif@pt.kfs.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Control group will receive Pelvic floor muscle training-associated EMG biofeedback.	Other: pelvic floor muscle training -associated EMG-biofeedback.; The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks
Experimental: experimental group; experimental group will receive Pelvic floor muscle training-associated EMG biofeedback while applying blood flow restriction to the proximal thigh.	Other: pelvic floor muscle training -associated EMG-biofeedback.; The control group will receive pelvic floor muscle training-associated EMG biofeedback for 10 weeks; Other: blood 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline,10 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL)	QOL will be measured by International consultation on incontinence questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS qol)	baseline,10 weeks, 16 weeks
self-esteem	self-esteem will be measured by Arabic Rosenberg self-esteem scale	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.	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	baseline,10 weeks, 16 weeks
pelvic floor muscle resting tone	pelvic floor muscle resting tone will be measured by Neurotrac myoplus pro EMG	baseline,10 weeks, 16 weeks
pelvic floor muscle endurance	pelvic floor muscle endurance will be measured by Neurotrac myoplus pro EMG	baseline,10 weeks, 16 weeks

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: KFSIRB200-800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No