The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 115
- 主要终点
- Changes from baseline at 3 and 6 months in One-hour Pad test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor who evaluated participants at baseline, 3 months, and 6 months was blinded and unaware of the participants' intervention group assignments
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
combination of PFMT and vaginal estrogen.
Patients were treated with a combination of a pelvic floor rehabilitation program and 0.5 mg vaginal estrogen.
干预措施: Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy (Combination Product)
vaginal estrogen
Patients were treated with 0.5 mg topical vaginal estrogen
干预措施: Vaginal estrogen (Drug)
结局指标
主要结局
Changes from baseline at 3 and 6 months in One-hour Pad test
时间窗: 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)
次要结局
- Changes from baseline at 3 and 6 months in Patient Global Impression of Improvement (PGI-I scale)(At baseline, 3 months, and 6 months)
- 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)
- Changes from baseline at 3 and 6 months in Oxford Scale(At baseline, 3 months, and 6 months)
- Changes from baseline at 3 and 6 months in Pelvic floor ultrasound assessment(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)(At baseline, 3 months, and 6 months)
- Changes from baseline at 3 and 6 months in total serum estradiol concentration(At baseline, 3 months, and 6 months)
研究者
Nguyen Quang Du
Principal Investigator
Hanoi Medical University