Clinical trial NCT04586166: Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
Official title: SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Pelvic Floor Disorders
Keywords: Retropubic Sling
Single-Incision Sling
Sacrocolpopexy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2020-10-14
Enrollment: 180
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with subjectively bothersome stress incontinence
timeFrame: 6 weeks after surgery
measure: Number of participants with subjectively bothersome stress incontinence
timeFrame: 1 year after surgery
measure: Number of participants with subjectively bothersome stress incontinence
timeFrame: 3 years after surgery
measure: Number of participants with subjectively bothersome stress incontinence
timeFrame: 5 years after surgery
Secondary outcomes:
measure: VAS (Visual Analogue Scale Surgeon ease of Use)
timeFrame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)
timeFrame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
measure: Pelvic Floor Impact (PFIQ-SF7)
timeFrame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
measure: Assessment of post-void residual (PVR) volume
timeFrame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
measure: Number of Participants needing Retreatment
timeFrame: 6 month up to 5 year post-surgery
measure: Number of Participants needing bladder drainage
timeFrame: beyond 6 weeks post-surgery
measure: Pelvic Floor Distress Inventory (PFDI-SF20)
timeFrame: Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5
Other outcomes:
Locations:
city: Coconut Creek
country: United States
facility: Florida Robotic and Minimally Invasive Urogynecology
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Cambridge
country: United States
facility: Boston Urogynecology Associates
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cape Town
country: South Africa
facility: Pelvic Floor Foundation of South Africa, University of Cape Town
Study officials:
affiliation: Wake Forest University Health Sciences
name: Catherine A Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: