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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.

Study Description
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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
Stress Urinary Incontinence Device: Solace Bladder Control (Vesair) Balloon Device: Solace Sham Treatment Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 11, 2014
Actual Primary Completion Date : December 18, 2015
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Vesair Balloon

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of treatment-related adverse events [ Time Frame: 3 Months ]
    Site-reported adverse events designated as related to the treatment

  2. Severity of treatment-related adverse events [ Time Frame: 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 [ Time Frame: 36 Months ]
    Comparison of increases in pad weight test and patient reported outcomes on questionnaires

  2. Severity of all adverse events [ Time Frame: 36 Months ]
    Site-reported adverse events designated as related to the treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210273


Locations
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Sponsors and Collaborators
Solace Therapeutics, Inc.
Investigators
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Principal Investigator: Eric Rovner, MD Medical University of South Carolina
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02210273    
Other Study ID Numbers: CD1001
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual records will not be made available to honor contracts with Investigators.

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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:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders