Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 20
- 主要终点
- Change From Baseline UDI Total Score
研究概览
简要总结
The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population.
A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
详细描述
ESTEEM is a multi-center randomized trial of 472 women with MUI who have elected to undergo surgical treatment for SUI. Participants will be randomized to a peri-operative BPTx program+MUS versus MUS alone. The purpose is to compare combined MUS+BPTx versus MUS alone (control) on improving MUI symptoms at 1 year.
Patients will be assigned to one of the two treatment groups. Randomization will be stratified by clinical site and by UUI "severity," which will be defined by the number of urgency urinary IEs on diary.
The primary outcome for this study is the mean change from baseline in UDI-total score at 1 year postoperative. The UDI is a validated, disease-specific, patient-reported outcome (PRO) measure.
Secondary outcomes UUI/OAB outcomes will be measured using the UDI-irritative subscale that measures symptom burden, impact, and changes related to OAB. It is highly responsive to treatment-related change and is able to discriminate among levels of change in all bladder diary variables (urinary urgency, frequency and urge incontinence) and patient ratings of treatment benefit that will characterize how MUS may affect all OAB symptoms individually and as a whole. SUI symptom outcomes will be measured using the UDI-stress subscale to compare SUI outcomes between women randomized to MUS + BPTx versus MUS alone.
Other UUI/OAB outcomes that will be compared between groups include 1) the change in IE frequency and type, number of urgency episodes, urgency severity with voids, number of diurnal voids, and number of nocturnal voids using a bladder diary; 2) patient satisfaction with treatment using the OAB-SAT-q; 3) bother and heal related quality of life using the OAB-q subscale
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
- Single (Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days
- •> 1 Stress IE/3 day diary
- •> 1 Urge IE/3 day diary
- •Reporting at least "moderate bother" from UUI item on the UDI "Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom?"
- •Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"
- •Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months
- •Desires surgical treatment for SUI symptoms
- •Urinary symptoms >3 months
- •Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol
- •Urodynamics within past 18 months
排除标准
- •Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
- •a)Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible
- •Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
- •a)Women undergoing only rectocele repair are eligible
- •Women undergoing hysterectomy for any indication will be excluded
- •Active pelvic organ malignancy
- •Age <21 years
- •Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum
- •Post-void residual >150 cc on 2 occasions, or current catheter use
- •Participation in other trial that may influence results of this study
- •Unevaluated hematuria
- •Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence
- •Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons
- •Women on anti-muscarinic therapy will be eligible after 3 week wash-out period
- •Non-ambulatory
- •History of serious adverse reaction to synthetic mesh
- •Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up
- •Women who only report "other IE" on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days
- •Diagnosis of and/or history of bladder pain or chronic pelvic pain
- •Women who had intravesical Botox injection within the past 12 months
结局指标
主要结局
Change From Baseline UDI Total Score
时间窗: 3, 6, and 12 Months
The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
次要结局
- Change From Baseline UDI Irritative Score(3, 6, and 12 Months)
- Change From Baseline UDI Stress Score(3, 6, and 12 Months)
- Change From Baseline UDI Obstructive Score(3, 6, and 12 Months)