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

Wake Forest University (WFU) logo

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

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

Trial contacts and locations

7

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Central trial contact

Catherine A Matthews, MD; Sachin N Vyas, MS,PhD

Data sourced from clinicaltrials.gov

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