Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 12
- 主要终点
- Count of Participants Requiring Bladder Drainage
研究概览
简要总结
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
详细描述
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy and risk always compete for equilibrium. Level I evidence has demonstrated a positive efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without, pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination of surgical treatment of POP and SUI at the same time, however, increases the risk of incomplete bladder emptying. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. As the combination of POP and sling surgery increases the risk of voiding dysfunction, and rates of incomplete bladder emptying appear significantly lower for SIS than RP slings, the study team hypothesizes that the use of the Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.
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 and will be masked during the one-year follow-up period.Precautions will be taken to minimize unmasking the study groups: Since RP slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS 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
- •Women being considered for a native tissue vaginal repair in any vaginal compartment or colpocleisis
- •POP ≥ stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
- •Vaginal bulge symptoms
- •Positive standardized cough stress test on clinical examination, or on urodynamic testing
- •Surgical plan that includes a native tissue vaginal repair including colpocleisis for symptomatic POP in any compartment
- •Understanding and acceptance of the need to return for all scheduled follow-up visits
- •English speaking and able to give informed consent
- •Willing and able to complete all study questionnaires
排除标准
- •Prior surgery for stress urinary incontinence
- •Status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse
- •Any serious disease, or chronic condition, that could interfere with the study compliance
- •Unwilling to have a synthetic sling
- •Inability to give informed consent
- •Pregnancy or planning pregnancy in the first postoperative year
- •Untreated urinary tract infection (may be included after resolution)
- •Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
- •Prior pelvic radiation
- •Incarcerated
- •Neurogenic bladder/ pre-operative self-catheterization
- •Elevated post-void residual (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
- •Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair
- •Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy.
结局指标
主要结局
Count of Participants Requiring Bladder Drainage
时间窗: 12 Month post-operatively
Beyond 2 weeks post-operatively with PVR \> 150 ml OR \> 1/3 total voided volume up to 12 Month post-operatively..
Number of Participants With Subjectively Bothersome Stress Incontinence
时间窗: 12 months post-operatively
Dichotomous outcome (Yes/No), 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
Count of Participants Needing Retreatment for Stress Incontinence
时间窗: 12 months post-operatively
This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
Count of Participants With De Novo or Worsening Urge Incontinence Symptoms
时间窗: 12 months post-operatively
Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. 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
Count of Participants Needing Surgical Intervention for Urinary Retention
时间窗: 12 Month post-operatively
Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
次要结局
- Number of Participants With Adverse Events(12 months post-operatively)
- Surgeon Satisfaction Scores(post-operatively up to 12 months)