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Solace Stress Urinary inContinence Control Efficacy and Safety Study

NCT02210273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2019-07-10

No results posted yet for this study

Summary

The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Solace Bladder Control (Vesair) Balloon

Subjects may undergo treatment every 12 months until study completion.

DEVICE

Solace Sham Treatment

Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon

Sponsors & Collaborators

  • Solace Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Rovner, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-11
Primary Completion
2015-12-18
Completion
2019-03-30
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 NCT02210273 on ClinicalTrials.gov