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

NCT04586166 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-02

No results posted yet for this study

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

Interventions

DEVICE

RP Sling

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

DEVICE

SIS

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Catherine A Matthews, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2031-12-31
Completion
2032-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586166 on ClinicalTrials.gov