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.
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.
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.
Parallel
Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy
Combination productGroup 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
Vaginal estrogen
DrugPatients 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 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)
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"
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
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)
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)
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