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SUCCESS: Solace Stress Urinary inContinence Control Efficacy and Safety Study

Sponsor
Solace Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02210273
Collaborator
(none)
221
Enrollment
20
Locations
2
Arms
55.6
Actual Duration (Months)
11.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Solace Bladder Control (Vesair) Balloon
  • Device: Solace Sham Treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
221 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
Actual Study Start Date :
Aug 11, 2014
Actual Primary Completion Date :
Dec 18, 2015
Actual Study Completion Date :
Mar 30, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in quality of life as assessed by pad weight tests assessments and questionnaires [3 Months]

      Comparison of increases in pad weight test and patient reported outcomes on questionnaires

    Secondary Outcome Measures

    1. Incidence of treatment-related adverse events [3 Months]

      Site-reported adverse events designated as related to the treatment

    2. Severity of treatment-related adverse events [3 Months]

      Site-reported adverse events designated as related to the treatment.

    Other Outcome Measures

    1. Improvement in quality of life in all patients assessed with pad weight tests and questionnaires [36 Months]

      Comparison of increases in pad weight test and patient reported outcomes on questionnaires

    2. Severity of all adverse events [36 Months]

      Site-reported adverse events designated as related to the treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Valley Urogynecology Associates Phoenix Arizona United States 85016
    2 Urological Associates of Southern Arizona Tucson Arizona United States 85715
    3 Genitourinary Surgical Consultants Denver Colorado United States 80220
    4 Urology Associates of Norwalk Norwalk Connecticut United States 06850
    5 WomanCare Arlington Heights Illinois United States 60004
    6 Women's Health Institute of Illinois Oak Lawn Illinois United States 60453
    7 Regional Urology Shreveport Louisiana United States 71106
    8 Chesapeake Urology Glen Burnie Maryland United States 21061
    9 Chesapeake Urology Owings Mills Maryland United States 21117
    10 Female Pelvic Medicine and Urogynecology Institute of Michigan Grand Rapids Michigan United States 49503
    11 North Shore LIJ Great Neck New York United States 11021
    12 Premier Medical Group Newburgh New York United States 12550
    13 Premier Medical Group Poughkeepsie New York United States 12601
    14 Lyndhurst Clinical Research Winston-Salem North Carolina United States 27103
    15 Women and Infants Hospital Providence Rhode Island United States 02905
    16 MUSC Urology Charleston South Carolina United States 29425
    17 Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic Sioux Falls South Dakota United States 57105
    18 Virginia Women's Center Richmond Virginia United States 23233
    19 Urology of Virginia Virginia Beach Virginia United States 23462
    20 Integrity Medical Research Mountlake Terrace Washington United States 98043

    Sponsors and Collaborators

    • Solace Therapeutics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Solace Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02210273
    Other Study ID Numbers:
    • CD1001
    First Posted:
    Aug 6, 2014
    Last Update Posted:
    Jul 10, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Solace Therapeutics, Inc.
    Stress Urinary Incontinence
    SUI
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Jul 10, 2019