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Clinical Trials/NCT07322250
NCT07322250
Not yet recruiting
Not Applicable

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

Kafrelsheikh University0 sites60 target enrollmentStarted: December 30, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
severity of stress urinary incontinence (SUI) symptoms.

Overview

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,

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

control group

Active Comparator

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

Intervention: pelvic floor muscle training -associated EMG-biofeedback. (Other)

experimental group

Experimental

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

Intervention: pelvic floor muscle training -associated EMG-biofeedback. (Other)

experimental group

Experimental

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

Intervention: blood flow restriction (Other)

Outcomes

Primary Outcomes

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

  • 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 endurance(baseline,10 weeks, 16 weeks)
  • pelvic floor muscle resting tone(baseline,10 weeks, 16 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hamdiah Mohmmed Altuwjry

physical therapist

Kafrelsheikh University

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