Stress Urinary Incontinence (SUI), Postmenopausal Women
Conditions
Keywords
stress urinary incontinence (SUI), postmenopausal women, Pelvic Floor Muscle Training, Vaginal Oestrogen, Pelvic floor rehabilitation
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 (SUI) in postmenopausal women compared to topical estrogen alone. The trial will also analyze factors related to the outcomes of the combined therapy. The key questions this trial aims to answer are: * Does the combination of PFMT and topical estrogen improve symptoms of stress urinary incontinence in postmenopausal women better than topical estrogen alone? * Which factors are associated with the effectiveness of the combined therapy? Researchers will compare the group receiving the combined therapy (pelvic floor muscle training plus topical estrogen) with the group receiving topical estrogen alone to determine whether adding PFMT to estrogen therapy provides additional treatment benefits for SUI in postmenopausal women. Participants will: \- Be randomly assigned to one of two groups: Group 1: Undergo a pelvic floor muscle training (PFMT) program combined with topical estrogen therapy (e.g., vaginal cream/application,...). Group 2: Receive topical estrogen therapy alone (e.g., vaginal cream/application,...). * Follow the assigned intervention protocol for a specified duration. * Attend regular clinic visits for clinical examinations, assessment of incontinence severity, and related measurements. * Monitor and record their incontinence symptoms and the frequency of urine leakage during daily activities.
Interventions
COMBINATION_PRODUCTCombined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy
Group 1: * Patients were instructed to identify and sense their pelvic floor muscles and to perform contraction-hold-relaxation exercises. * Exercises were performed at a frequency of 8 sets per session, 3 sessions per week, progressing from the supine position (month 1), to sitting (month 2), and to standing (month 3). Training was monitored by an electronic diary app. (Appendix) * Six individual 45-minute intervention sessions at the center using biofeedback, under the supervision of a physical therapy technician. (Appendix) * The training program consisted of two parts: resistance training and pre-contraction training (the Knack technique). (Appendix) * Patients were prescribed and instructed to use 0.5 mg vaginal estrogen for 6 months according to the following regimen: * First 4 weeks: insert one 0.5 mg tablet nightly at bedtime. * Next 20 weeks: insert one 0.5 mg tablet at bedtime twice weekly, with 2-3 days between doses
DRUGVaginal estrogen
Patients were prescribed and instructed to use 0.5 mg vaginal estrogen for 6 months according to the following regimen: First 4 weeks: insert one 0.5 mg tablet nightly at bedtime. Next 20 weeks: insert one 0.5 mg tablet at bedtime twice weekly, with 2-3 days between doses.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor who evaluated participants at baseline, 3 months, and 6 months was blinded and unaware of the participants' intervention group assignments
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline at 3 and 6 months in One-hour Pad test | At baseline, 3 months, and 6 months | One-hour pad test: A noninvasive method that measures the amount of urine leakage collected in an absorbent pad. Standardized by the International Continence Society (ICS), it quantifies leakage during everyday activities, measured in grams (g) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline at 3 and 6 months in International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF scale) | At baseline, 3 months, and 6 months | International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF scale): Assesses the severity of urinary incontinence and its impact on quality of life, with scores from 0 to 21. Higher scores indicate more severe incontinence |
| Changes from baseline at 3 and 6 months in Oxford Scale | At baseline, 3 months, and 6 months | Oxford Scale: Assesses pelvic floor muscle strength, ranging from 0 (no contraction) to 5 (strong contraction) |
| Changes from baseline at 3 and 6 months in Patient Global Impression of Improvement (PGI-I scale) | At baseline, 3 months, and 6 months | Patient Global Impression of Improvement (PGI-I): Assesses the degree of improvement in urinary incontinence after treatment based on the patient's perception. The scale ranges from very much better to very much worse |
| Changes from baseline at 3 and 6 months in Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol scale) | At baseline, 3 months, and 6 months | Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol scale): Assesses with a total score from 19 to 76 (higher scores reflect worse quality of life) |
| Changes from baseline at 3 and 6 months in total serum estradiol concentration | At baseline, 3 months, and 6 months | The concentration of estradiol in serum in all forms, measured in pg/mL |
| Changes from baseline at 3 and 6 months in Pelvic floor ultrasound assessment | At baseline, 3 months, and 6 months | Bladder neck displacement during pelvic floor muscle contraction on ultrasound: Measurement of bladder neck displacement during pelvic floor muscle contraction, in millimeters (mm) |
Contacts
Primary ContactDu Nguyen Quang
Outcome results
None listed