Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pelvic Floor Disorders
- Stress Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Participants will be masked during the five-year follow-up period. Precautions will be taken to minimize unmasking the study groups. Since RP (retropubic) slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS (Single-Incision Sling) group.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Only males
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).
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).
Tracking Information
- NCT #
- NCT04586166
- Collaborators
- Boston Scientific Corporation
- Investigators
- Principal Investigator: Catherine A Matthews, MD Wake Forest University Health Sciences
Get Well Soon