Stress Urinary IncontinenceSUCCESSNCT02210273
Solace Stress Urinary inContinence Control Efficacy and Safety Study
A study of Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 20 sitesUnited States
- Study dates
- 11 Aug 2014to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
WomanCare
Arlington Heights, Illinois, 60004
MUSC Urology
Charleston, South Carolina, 29425
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Chesapeake Urology
Glen Burnie, Maryland, 21061
Female Pelvic Medicine and Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49503
North Shore LIJ
Great Neck, New York, 11021
Integrity Medical Research
Mountlake Terrace, Washington, 98043
Premier Medical Group
Newburgh, New York, 12550
Urology Associates of Norwalk
Norwalk, Connecticut, 06850
Women's Health Institute of Illinois
Oak Lawn, Illinois, 60453
Chesapeake Urology
Owings Mills, Maryland, 21117
Valley Urogynecology Associates
Phoenix, Arizona, 85016
Premier Medical Group
Poughkeepsie, New York, 12601
Women and Infants Hospital
Providence, Rhode Island, 02905
Virginia Women's Center
Richmond, Virginia, 23233
Regional Urology
Shreveport, Louisiana, 71106
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Urology of Virginia
Virginia Beach, Virginia, 23462
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Solace Bladder Control (Vesair) Balloon, Solace Sham Treatment
- Keywords
- Stress Urinary Incontinence, SUI
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solace Bladder Control (Vesair) BalloonDevice
Also called Vesair Balloon
Subjects may undergo treatment every 12 months until study completion.
Solace Sham TreatmentDevice
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0 Receives: Device: Solace Bladder Control (Vesair) Balloon |
| Solace Sham Treatment | Sham comparator | Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months Receives: Device: Solace Bladder Control (Vesair) Balloon; Device: Solace Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Months
Secondary outcomes (2)
Incidence of treatment-related adverse events
Site-reported adverse events designated as related to the treatment
Measured: 3 Months
Severity of treatment-related adverse events
Site-reported adverse events designated as related to the treatment.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start11 Aug 2014
- Primary completion18 Dec 2015
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solace Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Rovner, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210273
- Sponsor's protocol ID
- CD1001
- Acronym
- SUCCESS
- Status last verified
- Jul 2019
- First submitted
- 4 Aug 2014
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual records will not be made available to honor contracts with Investigators.
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.
PubMed 29095516
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02210273
- Acronym / sponsor ID
- SUCCESS / CD1001
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, SUI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Solace Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2014 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Solace Bladder Control (Vesair) BalloonSubjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0 |
| Solace Sham Treatment | Sham comparator | Device: Solace Bladder Control (Vesair) Balloon, Device: Solace Sham TreatmentSubjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solace Bladder Control (Vesair) BalloonAlso: Vesair BalloonSubjects may undergo treatment every 12 months until study completion. | Device | Solace Sham Treatment, Treatment |
| Solace Sham TreatmentSham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon | Device | Solace Sham Treatment |
Primary outcome
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
2 secondary outcomes
Incidence of treatment-related adverse events
Time frame: 3 Months
Severity of treatment-related adverse events
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Derived from this study: PubMed 29095516McCammon 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.
- Individual participant dataSharing planned: No. Individual records will not be made available to honor contracts with Investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Rovner, MD principal investigator
Medical University of South Carolina
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.