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

Description

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.

Conditions

Stress Urinary Incontinence, Pelvic Floor Disorders

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Study Overview

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Study Details

Study overview

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.

SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy

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

Condition
Stress Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Coconut Creek

Florida Robotic and Minimally Invasive Urogynecology, Coconut Creek, Florida, United States, 33073

Augusta

Augusta University, Augusta, Georgia, United States, 30912

Chicago

Northwestern Medicine, Chicago, Illinois, United States, 60611

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Cambridge

Boston Urogynecology Associates, Cambridge, Massachusetts, United States, 02138

Winston-Salem

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States, 27101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Catherine A Matthews, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2032-12