Stress Urinary IncontinenceVECTORNCT03794206
Vesair Balloon Confirmatory Trial (VECTOR)
A study testing Vesair Balloon in people with Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 8 sites in United States.
Trial summary
Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Vesair Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Feb 2019to 28 Apr 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously treated with Vesair Balloon within the past 4 years
- Normal voiding function
- Has signed consent
- Willing to undergo cystoscopy
- Available for minimum of 12 months
Who cannot join
- Last Menstrual Period within past 4 years
- Systemic birth control medication (including implants) or systemic hormone replacement therapy (estrogen or progesterone) in the past 4 years.
- History of urosepsis, bladder infection, urinary tract infection or asymptomatic bacteriuria within the past 3 months.
- Urinary incontinence of neurogenic etiology.
- Prior pelvic surgery that may affect incontinence symptoms (including placement and/or removal of a suburethral sling) within the past 4 years.
- Noninvasive treatment for incontinence, such as nerve stimulation, Botox injections, biofeedback, formal pelvic floor muscle training, and/or vaginal laser therapy, within the past 3 months.
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- Taken medications other than anticholinergics that may affect SUI symptoms (such as enobosarm, duloxetine or imipramine) in the past 3 months.
- Taking other pharmacologic agents that may have a significant effect on bladder function unless on the therapy for at least 3 months and intending to continue the same dosage of the medication throughout the trial.
- History of recurrent (>1) kidney stones, or one kidney stone within the past 5 years.
- History of an artificial urinary sphincter.
- Presence of gross hematuria and/or blood clots in the urine.
- History of interstitial or follicular cystitis or other painful bladder syndrome.
- Cystocele verified as Stage 3 or higher by PoP-Q Classification.
- Local genital skin infection.
- Urethral or bladder inflammation and/or edema, or other hypersensitivity to cystoscopy or other urethral manipulations.
- Evidence of involuntary detrusor contractions and/or discomfort during bladder filling up to 300cc.
- Undergoing or anticipating a course of pelvic radiation therapy or with severe pelvic fibrosis from previous radiation therapy.
- Non-ambulatory, bedridden or physically unable to complete test exercises.
- History of recent alcoholism or illicit drug abuse within the last year.
- Immunologically suppressed or immunocompromised.
- History of any neurological disease that could impact bladder function including Parkinson's disease, multiple sclerosis or post-stroke sequelae.
- Uncontrolled diabetes (persistent A1C levels >9 percent).
- History of any malignancy (except non-melanoma skin cancer), unless the cancer was not in the urinary tract, the cancer was stage II or less, the cancer was treated with curative intent, AND there have been no clinical signs or symptoms of the malignancy for at least 2 years.
- Morbid obesity, defined as BMI ≥40.0.
- History of any autoimmune or connective tissue disease or disorder that could impact bladder function
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
WomanCare
Arlington Heights, Illinois, 60004
Chesapeake Urology
Hanover, Maryland, 21076
Washington Urology
Kirkland, Washington, 98034
Chesapeake Urology
Owings Mills, Maryland, 21117
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Women and Infants dept of Urogynecology
Providence, Rhode Island, 02903
Regional Urology
Shreveport, Louisiana, 71106
Urology of Virginia
Virginia Beach, Virginia, 23462
About this study
Official title: CD 1009 Rev A Page 1 of 44 23OCT2018 Vesair Balloon Confirmatory Trial (VECTOR) Use of the Next Generation Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Vesair Balloon
- 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.
Vesair BalloonDevice
Treatment with Vesair Balloon for one year
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Single-arm of subjects who receive treatment with Vesair Balloon Receives: Device: Vesair Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provocative Pad Weight
in-office Pad weight test
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 posted4 Jan 2019
- Study start11 Feb 2019
- Primary completion26 Aug 2019
- Study completion28 Apr 2022
Why it stopped: Company closure
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solace Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Rardin, M.D., Principal investigator, Women and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794206
- Sponsor's protocol ID
- CD1009
- Acronym
- VECTOR
- Status last verified
- Jun 2022
- First submitted
- 3 Jan 2019
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD 1009 Rev A Page 1 of 44 23OCT2018 Vesair Balloon Confirmatory Trial (VECTOR) Use of the Next Generation Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT03794206
- Acronym / sponsor ID
- VECTOR / CD1009
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company closure
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Solace Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 4 Jan 2019 (actual)
- 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.
Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Vesair BalloonSingle-arm of subjects who receive treatment with Vesair Balloon |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Previously treated with Vesair Balloon within the past 4 years
- Normal voiding function
- Has signed consent
- Willing to undergo cystoscopy
- Available for minimum of 12 months
Key exclusion criteria (25 listed)
- Last Menstrual Period within past 4 years
- Systemic birth control medication (including implants) or systemic hormone replacement therapy (estrogen or progesterone) in the past 4 years.
- History of urosepsis, bladder infection, urinary tract infection or asymptomatic bacteriuria within the past 3 months.
- Urinary incontinence of neurogenic etiology.
- Prior pelvic surgery that may affect incontinence symptoms (including placement and/or removal of a suburethral sling) within the past 4 years.
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 |
|---|---|---|
| Vesair BalloonTreatment with Vesair Balloon for one year | Device | Treatment Arm |
Primary outcome
Provocative Pad Weight
Time frame: 3 months
in-office Pad weight test
Results and safety
The study was stopped early (reason given: Company closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: 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
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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.
Charles Rardin, M.D. principal investigator
Women and Infants Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vesair Balloon in people with Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 8 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 5 inclusion and 25 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: stopped early, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 was stopped early (reason given: Company closure). Results are not available in the source record.
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?
Provocative Pad Weight (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 NCT03794206, 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 13 Jun 2022.