Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

Completed · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence, Pelvic Floor Disorders

In brief

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.

Key facts

Study ID: NCT03520114
Run by: Wake Forest University Health Sciences
People needed: 280
Starts: 2018-12-12
Expected to finish: 2024-01-02
Last updated by the study team: 2025-01-16

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

MedStar Health/National Center for Advance Pelvic Surgery — Washington D.C., District of Columbia, United States
Northwestern Medical Group — Chicago, Illinois, United States
Northwell Health — Manhasset, New York, United States
Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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