Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy (SASS)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Pelvic Floor Disorders; Stress Urinary Incontinence

Treatments: Device: SIS; Device: RP Sling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04586166

IRB00068839

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 180 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 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

SIS Group

Experimental group

Description:

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

Treatment:

Device: SIS