Solace Stress Urinary inContinence Control Efficacy and Safety Study (SUCCESS)

July 8, 2019 updated by: Solace Therapeutics, Inc.

Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.

All patients undergoing sham treatment are treated at 3 months.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Valley Urogynecology Associates
      • Tucson, Arizona, United States, 85715
        • Urological Associates of Southern Arizona
    • Colorado
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Urology Associates of Norwalk
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • WomanCare
      • Oak Lawn, Illinois, United States, 60453
        • Women's Health Institute of Illinois
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Chesapeake Urology
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Female Pelvic Medicine and Urogynecology Institute of Michigan
    • New York
      • Great Neck, New York, United States, 11021
        • North Shore LIJ
      • Newburgh, New York, United States, 12550
        • Premier Medical Group
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Urology
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
    • Virginia
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female 18 years of age or older with stress urinary incontinence (SUI)
  • Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
  • Willing to undergo cystoscopic procedures required and 36 month follow-up
  • On stable medication for a minimum of 3 months
  • Free of local genital skin infection
  • Positive Pad Weight Test
  • Free of impassable urethral strictures, trauma or necrosis

Exclusion Criteria:

  • Pregnant or planning to become pregnant during the study period
  • Non-ambulatory or bedridden or physically unable to complete test exercises
  • Morbidly obese (defined as BMI ≥ 40 kg/m2)
  • Incontinence of neurogenic etiology
  • Urge predominant Mixed Incontinence
  • Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection (UTI) within 3 months
  • History of recurrent urinary tract infections
  • Prior surgical procedure for incontinence within the past 6 months
  • Is taking medications for urinary incontinence other than anticholinergics
  • History of recurrent (>1) or recent (within 5 years) kidney stone(s)
  • Has a prosthetic heart valve
  • Unable to tolerate any form of antibiotic
  • Taking anticoagulation therapy, other than aspirin
  • Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
Device: Solace Bladder Control (Vesair) Balloon
Subjects may undergo treatment every 12 months until study completion.
Other Names:
  • Vesair Balloon
Sham Comparator: Solace Sham Treatment
Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months
Device: Solace Bladder Control (Vesair) Balloon
Subjects may undergo treatment every 12 months until study completion.
Other Names:
  • Vesair Balloon
Device: Solace Sham Treatment
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
Time Frame: 3 Months
Comparison of increases in pad weight test and patient reported outcomes on questionnaires
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events
Time Frame: 3 Months
Site-reported adverse events designated as related to the treatment
3 Months
Severity of treatment-related adverse events
Time Frame: 3 Months
Site-reported adverse events designated as related to the treatment.
3 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
Time Frame: 36 Months
Comparison of increases in pad weight test and patient reported outcomes on questionnaires
36 Months
Severity of all adverse events
Time Frame: 36 Months
Site-reported adverse events designated as related to the treatment.
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solace Therapeutics, Inc.

Investigators

  • Principal Investigator: Eric Rovner, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2014

Primary Completion (Actual)

December 18, 2015

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual records will not be made available to honor contracts with Investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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