Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatments solace bladder control balloon, solace sham treatment
Sponsor Solace Therapeutics, Inc.
Start date August 2014
End date August 2016
Trial size 220 participants
Trial identifier NCT02210273, CD1001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects undergoing treatment with the Solace Bladder Control Balloon on day 0
solace bladder control balloon
Subjects may undergo treatment every 12 months until study completion.
(Sham Comparator)
Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control Balloon at 3 months
solace bladder control balloon
Subjects may undergo treatment every 12 months until study completion.
solace sham treatment
Sham treatment that resembles treatment with the Solace Bladder Control Balloon

Primary Outcomes

Measure
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
time frame: 3 Months

Secondary Outcomes

Measure
Incidence of treatment-related adverse events
time frame: 3 Months
Severity of treatment-related adverse events
time frame: 3 Months

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
Principal investigator Eric Rovner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Solace Therapeutics, Inc..