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

NCT07322250 | Not Yet Recruiting

• 1 other identifier: KFSIRB200-800
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post Menopausal Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of life (QOL)

  baseline,10 weeks, 16 weeks

• self-esteem

  baseline,10 weeks, 16 weeks

• patient's global impression of improvement

  baseline,10 weeks, 16 weeks

• maximum voluntary isometric contraction (MVIC) of pelvic floor muscles

  baseline,10 weeks, 16 weeks

• pelvic floor muscle resting tone

  baseline,10 weeks, 16 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

Control group will receive Pelvic floor muscle training-associated EMG biofeedback.

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.

Other: pelvic floor muscle training -associated EMG-biofeedback.; Other: blood flow restriction

Interventions

pelvic floor muscle training -associated EMG-biofeedback. OTHER

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

control group; experimental group

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.

experimental group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Jilan Adel, lecturer

CONTACT

01007519909; gelan_youssif@pt.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12