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NCT Number: NCT07322250

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.

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Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 Restriction

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Quality of life (QOL)

    Time frame: baseline,10 weeks, 16 weeks

    QOL will be measured by International consultation on incontinence questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS qol)

  2. self-esteem

    Time frame: baseline,10 weeks, 16 weeks

    self-esteem will be measured by Arabic Rosenberg self-esteem scale

  3. patient's global impression of improvement

    Time frame: baseline,10 weeks, 16 weeks

    patient's global impression of improvement will be measured by Patient Global Impression of Improvement (PGI-I) scale.

  4. maximum voluntary isometric contraction (MVIC) of pelvic floor muscles

    Time frame: baseline,10 weeks, 16 weeks

    maximum voluntary isometric contraction (MVIC) of pelvic floor muscles will be measured by Neurotrac myoplus pro EMG

  5. pelvic floor muscle resting tone

    Time frame: baseline,10 weeks, 16 weeks

    pelvic floor muscle resting tone will be measured by Neurotrac myoplus pro EMG

  6. pelvic floor muscle endurance

    Time frame: baseline,10 weeks, 16 weeks

    pelvic floor muscle endurance will be measured by Neurotrac myoplus pro EMG

Study contacts

Contact information is provided by the study sponsor or research team.

Jilan Adel, lecturer

CONTACT

[email protected]

01007519909 ext. +2

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.