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

Last updated: May 28, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

RP Sling

SIS

Clinical Study ID

NCT04586166
IRB00068839
  • Ages > 21
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 21 years of age

  • Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3of 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 withoutconcomitant hysterectomy)

  • Objective SUI: positive standardized cough stress test on clinical examination or onurodynamic study with reduced prolapse

  • Understanding and acceptance of the need to return for all scheduled follow-upvisits and willing to complete study questionnaires

  • Able to give informed consent

Exclusion

Exclusion Criteria:

  • Prior surgery for stress urinary incontinence including mid-urethral sling;Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); andurethral bulking injection

  • Any serious disease, or chronic condition, that could interfere with the studycompliance

  • 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 prolapsereduction 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 perinealrectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy

  • Pregnant or Planning to Conceive

  • Incarcerated

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: RP Sling
Phase:
Study Start date:
December 23, 2020
Estimated Completion Date:
December 31, 2032

Study 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).

Connect with a study center

  • Pelvic Floor Foundation of South Africa, University of Cape Town

    Cape Town, 8001
    South Africa

    Suspended

  • Florida Robotic and Minimally Invasive Urogynecology

    Coconut Creek, Florida 33073
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Boston Urogynecology Associates

    Cambridge, Massachusetts 02138
    United States

    Active - Recruiting

  • Atrium Health

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27101
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.