The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- The Percent Reduction in Post Void Dribbling Episodes (Events)
研究概览
简要总结
This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.
详细描述
This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.
Secondary endpoints will include:
- The % of patients with at least a 50% reduction in post void dribbling episodes.
- Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.
We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18 and 89
- •Incontinence in the form of post void dribbling that occurs at least twice weekly.
排除标准
- •Severe renal or hepatic disease.
- •Active urinary tract infection.
- •Stress incontinence as the only incontinence symptom
- •Urge incontinence as the only incontinence symptom
- •Chronic severe constipation.
- •History of bladder cancer.
- •Known or suspected hypersensitivity to anticholinergics.
- •Any clinical condition that would not allow safe completion of the study.
- •Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.
- •Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.
- •Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.
研究组 & 干预措施
solifenacin
patients in this arm will receive drug
干预措施: solifenacin (Drug)
placebo
patients is this arm will receive placebo
干预措施: solifenacin (Drug)
结局指标
主要结局
The Percent Reduction in Post Void Dribbling Episodes (Events)
时间窗: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
次要结局
- the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes(outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12)
- Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)(outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment)