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

July 8, 2019 updated by: Solace Therapeutics, Inc.

Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Valley Urogynecology Associates
      • Tucson, Arizona, United States, 85715
        • Urological Associates of Southern Arizona
    • Colorado
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Urology Associates of Norwalk
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • WomanCare
      • Oak Lawn, Illinois, United States, 60453
        • Women's Health Institute of Illinois
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Chesapeake Urology
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Female Pelvic Medicine and Urogynecology Institute of Michigan
    • New York
      • Great Neck, New York, United States, 11021
        • North Shore LIJ
      • Newburgh, New York, United States, 12550
        • Premier Medical Group
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Urology
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
    • Virginia
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Vesair Balloon
Device: Solace Sham Treatment
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events
Time Frame: 3 Months
Site-reported adverse events designated as related to the treatment
3 Months
Severity of treatment-related adverse events
Time Frame: 3 Months
Site-reported adverse events designated as related to the treatment.
3 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
36 Months
Severity of all adverse events
Time Frame: 36 Months
Site-reported adverse events designated as related to the treatment.
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Solace Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Rovner, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CD1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual records will not be made available to honor contracts with Investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings