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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Solace Bladder Control (Vesair) Balloon
Solace Sham Treatment
Sponsored by
Solace Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, SUI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Valley Urogynecology Associates
  • Urological Associates of Southern Arizona
  • Genitourinary Surgical Consultants
  • Urology Associates of Norwalk
  • WomanCare
  • Women's Health Institute of Illinois
  • Regional Urology
  • Chesapeake Urology
  • Chesapeake Urology
  • Female Pelvic Medicine and Urogynecology Institute of Michigan
  • North Shore LIJ
  • Premier Medical Group
  • Premier Medical Group
  • Lyndhurst Clinical Research
  • Women and Infants Hospital
  • MUSC Urology
  • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
  • Virginia Women's Center
  • Urology of Virginia
  • Integrity Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Solace Sham Treatment

Arm Description

Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0

Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months

Outcomes

Primary Outcome Measures

Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
Comparison of increases in pad weight test and patient reported outcomes on questionnaires

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2014
Last Updated
July 8, 2019
Sponsor
Solace Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02210273
Brief Title
Solace Stress Urinary inContinence Control Efficacy and Safety Study
Acronym
SUCCESS
Official Title
Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 11, 2014 (Actual)
Primary Completion Date
December 18, 2015 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solace Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress Urinary Incontinence, SUI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
Arm Title
Solace Sham Treatment
Arm Type
Sham Comparator
Arm Description
Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months
Intervention Type
Device
Intervention Name(s)
Solace Bladder Control (Vesair) Balloon
Other Intervention Name(s)
Vesair Balloon
Intervention Description
Subjects may undergo treatment every 12 months until study completion.
Intervention Type
Device
Intervention Name(s)
Solace Sham Treatment
Intervention Description
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
Primary Outcome Measure Information:
Title
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
Description
Comparison of increases in pad weight test and patient reported outcomes on questionnaires
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Incidence of treatment-related adverse events
Description
Site-reported adverse events designated as related to the treatment
Time Frame
3 Months
Title
Severity of treatment-related adverse events
Description
Site-reported adverse events designated as related to the treatment.
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
Description
Comparison of increases in pad weight test and patient reported outcomes on questionnaires
Time Frame
36 Months
Title
Severity of all adverse events
Description
Site-reported adverse events designated as related to the treatment.
Time Frame
36 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Rovner, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Urogynecology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Urological Associates of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Urology Associates of Norwalk
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
WomanCare
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Women's Health Institute of Illinois
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Female Pelvic Medicine and Urogynecology Institute of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
North Shore LIJ
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Premier Medical Group
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Premier Medical Group
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
MUSC Urology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Integrity Medical Research
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual records will not be made available to honor contracts with Investigators.
Citations:
PubMed Identifier
29095516
Citation
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.
Results Reference
derived

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Solace Stress Urinary inContinence Control Efficacy and Safety Study

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