A Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms.
研究概览
简要总结
The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.
详细描述
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age >/= 18
- •Patient is appropriate for sub-urethral sling procedure
- •Mixed urinary incontinence
- •No antimuscarinic therapy for previous 30 days
排除标准
- •Uncontrolled narrow angle glaucoma
- •Acute cystitis
- •Unevaluated hematuria
- •Currently using anti-muscarinic therapy
- •Unable to complete pre-operative urodynamics
- •Contraindication to anti-cholinergic therapy
- •Unable or unwilling to complete diaries or quality of life questionaire
- •Significant (exteriorized) Pelvic Organ Prolapse
研究组 & 干预措施
Placebo Group
Placebo Orally 9 weeks once daily.
干预措施: Placebo (Other)
Solifenacin Group
Solifenacin Orally 9 weeks once daily.
干预措施: Solifenacin (Drug)
结局指标
主要结局
To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms.
时间窗: 9 weeks
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.
次要结局
未报告次要终点
研究者
Eric Hurtado
Investigator
The Cleveland Clinic