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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Florida Robotic and Minimally Invasive Urogynecology
ACTIVE_NOT_RECRUITING
Coconut Creek
Georgia
Augusta University
RECRUITING
Augusta
Illinois
Northwestern Medicine
ACTIVE_NOT_RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Massachusetts
Boston Urogynecology Associates
RECRUITING
Cambridge
North Carolina
Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
Other Locations
South Africa
Pelvic Floor Foundation of South Africa, University of Cape Town
SUSPENDED
Cape Town
Contact Information
Primary
Sachin N Vyas, MS,PhD
svyas@wakehealth.edu
336-713-4098
Backup
Catherine A Matthews, MD
Time Frame
Start Date: 2020-12-23
Estimated Completion Date: 2032-12
Participants
Target number of participants: 180
Treatments
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
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov