A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 358
- 试验地点
- 13
- 主要终点
- Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months.
研究概览
简要总结
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care.
The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) [for 1 or 2 injections in 12 months] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
详细描述
The BASIS trial is a multicentered, double-blind, randomized controlled, surgical trial with two active interventions, 1) a transurethral bulking agent (TBA) or 2) a single-incision sling (SIS). Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use. Participants will be randomly assigned to one of the interventions. A total of 358 women will be randomized 1:1 to TBA or SIS.
All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence collected at baseline. After undergoing treatment (either transurethral bulking agent or single-incision sling), participants will be asked to return to the clinic at 2-4 weeks, 3 months, and 12 months with additional follow-ups at 6 months, 24 months, and 36 months done over the phone.
The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs. SIS at 12 months.
Secondary outcomes include assessments of 1) retreatment rates within 12 months; 2) validated, objective measures of condition improvement through 36 months; 3) objective success at 3 and 12 months as measured by standardized cough stress test; 4) functional outcomes (activity level, perceived recover, sexual function, etc.); 5) quality of life assessments; 6) operative procedure data and adverse events; 7) pain and functional activity, need for sedation and anesthesia, de novo or worsening symptoms; 8) medical resource use (additional medications, procedures, or therapies); and 9) healthy utility measures.
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
- Double (Participant, Outcomes Assessor)
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
- •Women ≥ 21 years
- •For > 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required.
- •A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months.
- •Normal PVR < 150 mL
- •Candidate for either study procedure as determined by treating surgeon
- •Available for up to 3 years.
- •Agrees to randomization.
排除标准
- •Anterior/apical vaginal prolapse beyond the hymen (>0 on POPQ)
- •Urge-predominant mixed UI despite stable therapy
- •Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment.
- •Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months.
- •Malignancy or history of radiation of the pelvis
- •Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year
- •Incomplete emptying (PVR > 150mL)
- •Prior anti-incontinence procedure
- •Neurogenic bladder
- •Unwilling to continue current UUI treatment until completion of primary outcome at 12 months
- •Prior adverse reaction to synthetic mesh or urethral bulking material
- •Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.)
- •Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.
研究组 & 干预措施
Solyx Single-incision Sling
Solyx Single-incision Sling
干预措施: Solyx Single-incision Sling (Device)
Bulkamid Transurethral Bulking Agent
Bulkamid Transurethral Bulking Agent
干预措施: Bulkamid Transurethral Bulking Agent (Device)
结局指标
主要结局
Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months.
时间窗: At 12 months post-intervention.
The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence.
次要结局
- New or worsening urge incontinence function(From intervention to 36 months post-intervention.)
- Quality of life improvement measured by Decision Regret Scale- Satisfaction with Decision Scale [DRS-SDS] for TBA vs. SIS(From baseline to 36 months post-intervention.)
- Blood Loss(At intervention)
- Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS(From 3 months to 36 months post-intervention.)
- Condition improvement measured by Patient Global Impression of Severity [PGI-S] for TBA vs. SIS(From intervention to 36 months post-intervention.)
- Objective success by standardized cough testing(From 3 to 12 months post-intervention.)
- Sexual functional measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised [PISQ-IR] for TBA vs. SIS(From intervention to 36 months post-intervention.)
- Operative Procedure-related adverse events(At intervention)
- Rates of retreatment(From intervention to 12 months post-intervention.)
- Quality of life improvement measured by 36-Item Short Form Health Survey [SF-36] for TBA vs. SIS(From baseline to 36 months post-intervention.)
- Functional activity measured by Activity Assessment Scale [AAS] for TBA vs. SIS(From intervention to 36 months post-intervention.)
- Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score(From intervention to 36 months post-intervention.)
- Condition improvement measured by Patient Global Symptom Control [PGSC] for TBA vs. SIS(From interventions to 36 months post-intervention.)
- Condition improvement measured by Urogenital Distress Inventory - Long Form [UDI-LF] for TBA vs. SIS(From intervention to 36 months post-intervention.)
- Post-op pain(Between 3 and 12 months post-intervention)
- Intraoperative Pain management(At intervention)
- Health utility measure measured by the European Quality of Life-5 Dimensions (EQ-5D-5L)(From baseline to 36 months post-intervention.)
- Quality of life improvement measured by Incontinence Impact Questionnaire - Long Form [IIQ-LF] for TBA vs. SIS(From baseline to 36 months post-intervention.)
- Operative time(At intervention)
- Medical Resource Cost(From intervention to 36 months post-intervention.)
- Medical resource use(From intervention to 36 months post-intervention.)