TOMUS-Trial Of Mid-Urethral Slings
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 597
- 试验地点
- 22
- 主要终点
- Objective Treatment Success at 12 Months
研究概览
简要总结
The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.
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
- •Stress urinary incontinence (SUI) as evidenced by all of the following:
- •Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
- •Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
- •Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
- •Bladder capacity ≥ 200ml by stress test
- •Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed
- •Eligible for both retropubic and transobturator procedures
- •No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
- •American Society of Anesthesiologists (ASA) class I, II, or III
- •No current intermittent catheterization
- •Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
- •Signed consent form
排除标准
- •Age <21 years
- •Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
- •Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
- •Current chemotherapy or current or history of pelvic radiation therapy
- •Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
- •Urethral diverticulum, current or previous (i.e. repaired)
- •Prior augmentation cystoplasty or artificial sphincter
- •Implanted nerve stimulators for urinary symptoms
- •History of synthetic sling for stress urinary incontinence
- •<12 months post-partum
- •Laparoscopic or open pelvic surgery <3 months*
- •Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
- •Participation in another treatment intervention trial that might influence the results of this trial
- •Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
- •Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI
结局指标
主要结局
Objective Treatment Success at 12 Months
时间窗: 12 months
Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is \<15g/24 hrs.
Subjective Treatment Success at 12 Months
时间窗: 12 months
Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.
次要结局
- Patient Satisfaction at 12 Months(Follow-Up)
- Change in Quality of Life From Baseline to 12 Months(Baseline - 12 months)
- Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months(12 months)