The Effect of Blood Flow Restriction Training on Postmenopausal Stress Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pelvic floor muscle training -associated EMG-biofeedback., blood flow restriction.
- Who it may be relevant to
- Registry conditions: Post Menopausal Stress Urinary Incontinence. Basic parameters: 45 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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,
Interventions
- 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.
Primary outcome measures
- severity of stress urinary incontinence (SUI) symptoms. [Time frame: baseline,10 weeks, 16 weeks]
Secondary outcome measures (6)
- Quality of life (QOL) [Time frame: baseline,10 weeks, 16 weeks]
- self-esteem [Time frame: baseline,10 weeks, 16 weeks]
- patient's global impression of improvement [Time frame: baseline,10 weeks, 16 weeks]
- maximum voluntary isometric contraction (MVIC) of pelvic floor muscles [Time frame: baseline,10 weeks, 16 weeks]
- pelvic floor muscle resting tone [Time frame: baseline,10 weeks, 16 weeks]
- pelvic floor muscle endurance [Time frame: baseline,10 weeks, 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07322250 · KFSIRB200-800