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Not recruiting

Solyx vs. Retropubic

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04586166

Conditions

Stress Urinary Incontinence

Pelvic Floor Disorders

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

RP Sling

SIS

Study Details

Brief 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.

Conditions

Stress Urinary Incontinence

Pelvic Floor Disorders

Study ID

NCT04586166

Start date

Dec 23, 2020

Status verified date

Apr, 2025

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RP Sling Group

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

experimental: SIS Group

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

Interventions

RP Sling

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

SIS

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

Primary outcome measure

  • Number of participants with subjectively bothersome stress incontinence [ Time Frame: 6 weeks after surgery ]
  • Number of participants with subjectively bothersome stress incontinence [ Time Frame: 1 year after surgery ]
  • Number of participants with subjectively bothersome stress incontinence [ Time Frame: 3 years after surgery ]
  • Number of participants with subjectively bothersome stress incontinence [ Time Frame: 5 years after surgery ]

Central Contacts and Locations

Central contacts

Sachin N Vyas, MS,PhD

336-713-4098svyas@wakehealth.edu

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Torri Blackmon

706-721-1088TBlackm2@augusta.edu

Principal Investigator:

Jennifer Lanzer, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Kimberly Kenton, MD

Kimberly.Kenton@bsd.uchicago.edu

Boston Urogynecology Associates

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Peter L Rosenblatt

617-354-5452

Principal Investigator:

Peter L Rosenblatt, MD

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27101

Contacts

Sachin N Vyas, MS,PhD

336-713-4098

Principal Investigator:

Catherine A Matthews, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 29, 2025

Last verified

Apr, 2025

Keywords

  • Retropubic Sling
  • Single-Incision Sling
  • Sacrocolpopexy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-04-29.