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

• ClinicalTrials.gov Identifier: NCT02210273
• Recruitment Status: Completed
• First Posted: August 6, 2014
• Last Update Posted: July 10, 2019
• Sponsor: Solace Therapeutics, Inc.
• Information provided by (Responsible Party): Solace Therapeutics, Inc.

Tracking Information

• First Submitted Date: August 4, 2014
• First Posted Date: August 6, 2014
• Last Update Posted Date: July 10, 2019
• Actual Study Start Date: August 11, 2014
• Actual Primary Completion Date: December 18, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: 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: Solace Stress Urinary inContinence Control Efficacy and Safety Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stress Urinary Incontinence

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 2, 2019): 221
• Original Enrollment: Not Provided
• Actual Study Completion Date: March 30, 2019
• Actual Primary Completion Date: December 18, 2015 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02210273
• Other Study ID Numbers: 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

• 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: Solace Therapeutics, Inc.
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

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

• PRS Account: Solace Therapeutics, Inc.
• Verification Date: July 2019