Status:
NOT_YET_RECRUITING
The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence
Lead Sponsor:
Hanoi Medical University
Conditions:
Stress Urinary Incontinence (SUI)
Postmenopausal Women
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The objective of this clinical trial is to investigate whether the combination of pelvic floor muscle training (PFMT) and topical estrogen is more effective in treating stress urinary incontinence (SU...
Eligibility Criteria
Inclusion
- Patients diagnosed with stress urinary incontinence.
- Women who have been naturally postmenopausal for at least 1 year or are postmenopausal due to bilateral oophorectomy (surgical removal of both ovaries).
- Have had sexual intercourse to ensure feasibility of urogenital tract examination and assessment.
- Patients who consent to participate in the study and comply with the treatment protocol, including performing pelvic floor muscle training (PFMT) and completing topical vaginal estrogen therapy.
Exclusion
- Patients with concomitant neurological disorders, urinary tract infections, prior pelvic radiotherapy, or congenital malformations of the lower urinary tract.
- Genitourinary malformations or fistulas causing continuous urinary incontinence.
- Genitourinary cancers or tumors of the urinary tract.
- History of spinal cord injury or central nervous system injury affecting the centers that control urination.
- Patients previously treated for stress urinary incontinence (SUI) (surgery, medications, exercises).
- Patients with severe heart disease, coronary artery disease, or myocardial ischemia.
- Patients with pelvic organ prolapse stage III or higher, unexplained vaginal bleeding, confirmed or suspected breast cancer, or vaginitis.
- Presence of premalignant factors or suspected steroid-dependent cancers such as endometrial carcinoma.
- History of or current hepatic tumors, or progressive liver or biliary disease.
- Coagulation/thrombotic disorders, or a history of thromboembolism or stroke.
- Severe hypertriglyceridemia.
- Hypersensitivity to any component of vaginally administered estrogen products.
- The patient or family members are unable to use a smartphone (Android or iOS) to participate in the monitoring program.
- The patient does not agree to participate in the study.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT07186985
Start Date
November 1 2025
End Date
February 28 2027
Last Update
September 22 2025
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