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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:
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,...).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination of PFMT and vaginal estrogen. | Experimental | Patients were treated with a combination of a pelvic floor rehabilitation program and 0.5 mg vaginal estrogen. |
|
| vaginal estrogen | Active Comparator | Patients were treated with 0.5 mg topical vaginal estrogen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy | Combination Product | Group 1:
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline at 3 and 6 months in One-hour Pad test | 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) | At baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline at 3 and 6 months in Patient Global Impression of Improvement (PGI-I scale) | 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" | At baseline, 3 months, and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
The study population consisted of postmenopausal women with stress urinary incontinence
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Du Nguyen Quang | Contact | +84 337828793 | nguyenquangdu.hmuh@gmail.com |
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The assessor who evaluated participants at baseline, 3 months, and 6 months was blinded and unaware of the participants' intervention group assignments
|
| Vaginal estrogen | Drug | 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. |
|
| Changes from baseline at 3 and 6 months in International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF scale) | 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 | At baseline, 3 months, and 6 months |
| Changes from baseline at 3 and 6 months in Oxford Scale | Oxford Scale: Assesses pelvic floor muscle strength, ranging from 0 (no contraction) to 5 (strong contraction) | At baseline, 3 months, and 6 months |
| Changes from baseline at 3 and 6 months in Pelvic floor ultrasound assessment | Bladder neck displacement during pelvic floor muscle contraction on ultrasound: Measurement of bladder neck displacement during pelvic floor muscle contraction, in millimeters (mm) | At baseline, 3 months, and 6 months |
| Changes from baseline at 3 and 6 months in Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol scale) | 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) | At baseline, 3 months, and 6 months |
| Changes from baseline at 3 and 6 months in total serum estradiol concentration | The concentration of estradiol in serum in all forms, measured in pg/mL | At baseline, 3 months, and 6 months |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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