Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 14
- 主要终点
- Overactive Bladder Symptom Score percentage reduction
研究概览
简要总结
Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage.
Women who join the study will be randomly placed into one of two groups:
One group will take tadalafil (5 mg), a medicine taken once a day.
The other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day.
The study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits.
The main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects.
Women aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •OAB symptoms persisting for ≥3 months
- •OAB Symptom Score (OABSS) > 5 and urgency sub-score of OABSS ≥ 2
- •Ability and willingness to provide informed consent.
排除标准
- •Active urinary tract infection.
- •Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI
- •Pelvic organ prolapse stage ≥II according to POP-Q system.
- •History of pelvic radiation.
- •History of neurosurgical interventions.
- •Pregnancy or breastfeeding.
- •Neuropathic diseases affecting the lower urinary tract.
- •History of genitourinary malignancy.
- •Post-void residual urine (PVR) > 150 ml.
- •Vesical or lower ureteric stones.
- •Uncontrolled diabetes mellitus (HbA1c > 7).
- •Any psychological or psychiatric disorders.
- •Contraindications or allergy to the used medications.
- •History of surgeries in the urinary bladder.
- •History of pelvic surgeries within 6 months.
- •Voiding dysfunctions.
研究组 & 干预措施
Group 1, Low dose Tadalafil group
Participants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks
干预措施: Tadalafil 5 mg (Drug)
Group 2: Solifenacin Group
Participants will receive solifenacin succinate 5 mg orally once daily for the duration of 12 weeks
干预措施: Solifenacin 5mg (Drug)
结局指标
主要结局
Overactive Bladder Symptom Score percentage reduction
时间窗: from enrollment to 12 weeks
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms. Three points reduction in the total OABSS is determined as the minimal threshold for a meaningful change
次要结局
- Changes in frequnecy episodes in three-day voiding diary(from enrollment to follow up visits at 4,8 and 12 weeks)
- changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score(from enrollment to follow up visits at 4,8 and 12 weeks)
- changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)(All follow up visits at 4, 8, and 12 weeks)
- Changes in number of nocturia episodes on three-day urinary diary(from enrollment to follow up visits at 4,8 and 12 weeks)
- Changes in number of urgency episodes on three-day urinary diary(from enrollment to follow up visits at 4,8 and 12 weeks)
- Changes in number of incontinence episodes on three-day voiding diary(from enrollment to follow up visits at 4,8 and 12 weeks)