Stress Urinary IncontinenceVESICALNCT03082118
Vesair Continued Access Trial
A study of Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 7 sites in United States.
Trial summary
Single arm study of the Vesair Balloon in postmenopausal women. 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?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Mar 2017to 15 Jan 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
- Post-menopausal women with SUI or stress predominant mixed incontinence
- Maximum score on IQOL of 60
- Positive cough test for leakage
- Willing to undergo procedures
- Free from infection
- Have previously tried (and failed) noninvasive treatment for SUI
Who cannot join
- SUI due to SUI
- Urge-predominant mixed incontinence
- Incontinence of neurogenic etiology
- 2 or more UTIs in past year and 1 in past 3 months
- Surgery for SUI in the past 6 months
- taking medication that can be used to treat SUI
Show all 20Show fewer
- taking medication that affects urinary symptoms for less than 3 months
- undergoing biofeedback
- Grade 3 or worse cystocele
- last menstrual period within 12 months
- oral progesterone or estrogen in the past 12 months
- BMI > 40
- involuntary detrusor contractions or discomfort during bladder filling
- previous stage III or worse cancer
- previous cancer of the urinary tract
- previous symptoms for early stage cancer in the past 2 years
- anticoagulation therapy other than aspirin
- history of prosthetic heart valve
- neurological or connective tissue condition or disease affecting bladder function
- known allergy to device components
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Georgia Center for Women
Atlanta, Georgia, 30312
Kaiser Permanente Urology
Los Angeles, California, 90027
Riddle Hospital, Main Line Health
Media, Pennsylvania, 19063
West Penn Hospital, Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Kaiser Permanente Urogynecology
San Diego, California, 92110
Regional Urology
Shreveport, Louisiana, 71106
About this study
Official title: Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
Single arm study of the Vesair Balloon in postmenopausal women.
Read the detailed description
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Vesair Bladder Control System
- 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 Bladder Control SystemDevice
Also called Vesair Balloon
Intravesical balloon
| Study group | Role | What they receive |
|---|---|---|
| Vesair Arm | Experimental | Subjects treated with the Vesair Bladder Control System at enrollment. Receives: Device: Vesair Bladder Control System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on patient-reported outcomes
Improvement reported on questionnaires
Measured: 3-12 months
Secondary outcomes (1)
Reduction in leakage events
Reduction in leakage events reported on a voiding diary
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start9 Mar 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- All women enrolled are treated.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solace Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082118
- Sponsor's protocol ID
- CD1007
- Acronym
- VESICAL
- Status last verified
- Jul 2019
- First submitted
- 11 Mar 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03082118
- Acronym / sponsor ID
- VESICAL / CD1007
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Solace Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 17 Mar 2017 (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.
Single arm study of the Vesair Balloon in postmenopausal women.
Detailed description
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All women enrolled are treated.
| Arm | Type | Receives |
|---|---|---|
| Vesair Arm | Experimental | Device: Vesair Bladder Control SystemSubjects treated with the Vesair Bladder Control System at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post-menopausal women with SUI or stress predominant mixed incontinence
- Maximum score on IQOL of 60
- Positive cough test for leakage
- Willing to undergo procedures
- Free from infection
Key exclusion criteria (20 listed)
- SUI due to SUI
- Urge-predominant mixed incontinence
- Incontinence of neurogenic etiology
- 2 or more UTIs in past year and 1 in past 3 months
- Surgery for SUI in the past 6 months
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 Bladder Control SystemAlso: Vesair BalloonIntravesical balloon | Device | Vesair Arm |
Primary outcome
Improvement on patient-reported outcomes
Time frame: 3-12 months
Improvement reported on questionnaires
1 secondary outcome
Reduction in leakage events
Time frame: 3-12 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 5 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 7 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 6 inclusion and 20 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 5 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 7 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 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 on patient-reported outcomes (time frame: 3-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.