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Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence

NCT01784588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2021-02-10

Study results available
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Summary

The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Solyx Single Incision Sling System

Solyx Single Incision Sling System

DEVICE

Obtryx II Sling System

Standard outside-in transobturator sling

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Amanda White, MD · University of Texas

  • Joseph Schaffer, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-01-17
Completion
2018-01-17

Countries

  • United States
  • Australia

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 NCT01784588 on ClinicalTrials.gov