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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210273
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 4, 2014
First Posted Date  ICMJE August 6, 2014
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE August 11, 2014
Actual Primary Completion Date December 18, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
  • Incidence of treatment-related adverse events [ Time Frame: 3 Months ]
    Site-reported adverse events designated as related to the treatment
  • Severity of treatment-related adverse events [ Time Frame: 3 Months ]
    Site-reported adverse events designated as related to the treatment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 15, 2017)
  • 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
  • Severity of all adverse events [ Time Frame: 36 Months ]
    Site-reported adverse events designated as related to the treatment.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Solace Stress Urinary inContinence Control Efficacy and Safety Study
Official Title  ICMJE Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE
  • Device: Solace Bladder Control (Vesair) Balloon
    Subjects may undergo treatment every 12 months until study completion.
    Other Name: Vesair Balloon
  • Device: Solace Sham Treatment
    Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
Study Arms  ICMJE
  • Experimental: Treatment
    Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
    Intervention: Device: Solace Bladder Control (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
    Interventions:
    • Device: Solace Bladder Control (Vesair) Balloon
    • Device: Solace Sham Treatment
Publications * McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
221
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date December 18, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02210273
Other Study ID Numbers  ICMJE CD1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual records will not be made available to honor contracts with Investigators.
Current Responsible Party Solace Therapeutics, Inc.
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Solace Therapeutics, Inc.
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Rovner, MD Medical University of South Carolina
PRS Account Solace Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP