Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
- Conditions
- Pelvic Floor DisordersStress Urinary Incontinence
- Interventions
- Device: RP sling placementDevice: SIS placement
- Registration Number
- NCT03520114
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 280
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RP sling group RP sling placement Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. SIS group SIS placement Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
- Primary Outcome Measures
Name Time Method Retreatment for stress incontinence 12 months post-operatively This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
Number of participants with subjectively bothersome stress incontinence 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
Requirement for bladder drainage 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..
De novo or worsening urge incontinence symptoms 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
Surgical intervention for urinary retention 12 Month post-operatively Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
- Secondary Outcome Measures
Name Time Method Adverse events 12 months post-operatively Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
Surgeon satisfaction post-operatively up to 12 months Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied.
Change in pain up to 12 months post-operatively Pain will be measured on a visual analogue scale for 14 days post-operatively and at 6 weeks and 12 months post-operatively. The scale has a score range of 0-10, with 0=no pain and 10=worst pain .
Trial Locations
- Locations (6)
Northwell Health
🇺🇸Manhasset, New York, United States
Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
MedStar Health/National Center for Advance Pelvic Surgery
🇺🇸Washington, District of Columbia, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Northwestern Medical Group
🇺🇸Chicago, Illinois, United States