Mixed Incontinence: Medical Or Surgical Approach?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Optimal Outcome of Treatment at 6 Months
研究概览
简要总结
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
详细描述
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C)
- •Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
- •Incontinence symptoms present for at least (3) months*
- •Bladder capacity > 200cc (by any method)
- •Urodynamic Stress Incontinence
- •Eligible for both treatment interventions
- •Available to start intervention within 6 weeks
- •Negative urine dipstick (negative result = trace or less for leukocytes & nitrites)
- •Available for 12 months of follow-up and able to complete study assessments as per clinician judgment
- •Signed consent form
排除标准
- •Age <21 years*
- •Currently undergoing or recommended to undergo treatment of pelvic organ prolapse
- •Other indicated/planned concomitant surgery
- •Pregnant or has not completed child bearing*
- •<12 months post-partum*†
- •Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder of any Stage
- •Current catheter use
- •Unevaluated hematuria
- •Participation in another trial that may influence the results of this study
- •Patient can be rescreened after respective time interval has been met. †"Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
研究组 & 干预措施
Surgical Treatment
Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
干预措施: Surgical (Procedure)
Non Surgical Treatment
The non-surgical treatment will include two components:
- Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and
- Behavioral therapy.
干预措施: Non-Surgical Intervention (Drug)
结局指标
主要结局
Optimal Outcome of Treatment at 6 Months
时间窗: 6 Months
Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how your urinary tract condition is now" with responses ranging from 1 = "Normal" to 4 "Severe".
次要结局
- Optimal Outcome of Treatment at 3 Months(3 months)