A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 试验地点
- 20
- 主要终点
- Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.
研究概览
简要总结
Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?
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
- •Predominant SUI as evidenced by all of the following:
- •Self-reported stress-type UI symptoms, of duration >3 months*
- •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 any volume
- •Eligible for randomization to either treatment group
- •Eligible for SUI surgery
- •Desires non-conservative therapy for SUI
- •PVR <150ml by any method. (May repeat once if initial measure is abnormal)
- •Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) or negative UA or negative culture
- •Available to initiate SUI treatment within 6 weeks of randomization
- •Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
- •Signed consent form.
- •Patient can be rescreened after respective time interval has been met.
排除标准
- •Age <21 years*
- •Currently undergoing or has had recommended treatment of apical or anterior prolapse
- •No anterior or apical prolapse > +1 on standing straining prolapse exam
- •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
- •History of pelvic radiation therapy
- •Previous incontinence surgery
- •Current catheter use
- •Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
- •Previous (i.e. repaired) or current urethral diverticulum
- •Prior augmentation cystoplasty or artificial sphincter
- •Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
- •Any pelvic surgery within the last 3 months*
- •Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
- •Participation in another treatment intervention trial that might influence results of this trial.
- •A urodynamic result reviewed by the investigator in the preceding 12 months or any recollection by the investigator of urodynamic results on that subject.
- •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.
结局指标
主要结局
Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.
时间窗: 12 Months
Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better" at 12 months.
次要结局
- Patient Global Impression Index(12 Months)
- Change in Bother as Measured by the UDI(Baseline, 12 Months)
- Change in Severity as Measured by the ISI(Baseline & 12 Months)
- Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months(Baseline, 12 mos)
- Change in MESA Stress Score(Screen & 12 Months)
- Change in MESA Urge Score(Screen & 12 Months)
- Change in Quality of Life as Measured by the IIQ(Baseline, 12 Months)
- Change in Quality of Life as Measured by the SF-12(Baseline, 12 Months)
- Change in Severity as Measured by the PGI-S(Baseline & 12 Months)
- Moderate or Severe Severity as Measured by the PGI-S(12 Months)
- Patient Satisfaction With Treatment Outcome(12 Months)
- Stress Test at 12 Mos(Screen and 12 months)