SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 12
- 主要终点
- Number of participants with subjectively bothersome stress incontinence
研究概览
简要总结
SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.
详细描述
SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (SUI).
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 (Participant)
盲法说明
Participants will be masked during the five-year follow-up period. Precautions will be taken to minimize unmasking the study groups. Since RP (retropubic) slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS (Single-Incision Sling) group.
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
- •At least 21 years of age
- •Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3 of the PFDI-SF20
- •POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent
- •Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy)
- •Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse
- •Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires
- •Able to give informed consent
排除标准
- •Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection
- •Any serious disease, or chronic condition, that could interfere with the study compliance
- •Unwilling to have a synthetic sling
- •Untreated and unresolved urinary tract infection
- •Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
- •Neurogenic bladder/ pre-operative self-catheterization
- •Elevated post-void residual/PVR (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
- •Prior pelvic radiation
- •Inflammatory bowel disease
- •Current genitourinary fistula or urethral diverticulum
- •Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy
- •Pregnant or Planning to Conceive
- •Incarcerated
结局指标
主要结局
Number of participants with subjectively bothersome stress incontinence
时间窗: 5 years after surgery
Measured by a positive response of \> 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
次要结局
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)(Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5)
- Pelvic Floor Impact (PFIQ-SF7)(Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5)
- Assessment of post-void residual (PVR) volume(Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5)
- Number of Participants needing Retreatment(6 month up to 5 year post-surgery)
- Number of Participants needing bladder drainage(beyond 6 weeks post-surgery)
- VAS (Visual Analogue Scale Surgeon ease of Use)(Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5)
- Patient Global Impression of Improvement (PGI-I)(Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5)
- Pelvic Floor Distress Inventory (PFDI-SF20)(Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5)