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

Kafrelsheikh University

Status: Not yet enrolling

Conditions: Post Menopausal Stress Urinary Incontinence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07322250

KFSIRB200-800

Details and patient eligibility

About

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

Full 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,

Enrollment: 60 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

control group

Active Comparator group

Description:

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

Treatment:

Other: pelvic floor muscle training -associated EMG-biofeedback.

experimental group

Experimental group

Description:

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

Treatment:

Other: pelvic floor muscle training -associated EMG-biofeedback.

Other: blood flow restriction