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

Wake Forest University (WFU)

Status: Completed

Conditions: Pelvic Floor Disorders; Stress Urinary Incontinence

Treatments: Device: SIS placement; Device: RP sling placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03520114

IRB00050256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

RP sling group

Experimental group

Description:

Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.

Treatment:

Device: RP sling placement

SIS group

Experimental group

Description:

Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.

Treatment:

Device: SIS placement