Stress Urinary IncontinenceNCT04206085
Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
A study testing Viveve - Active and Viveve - Cryogen-Alone in people with Stress Urinary Incontinence, run by Viveve Inc. at 3 sites in Canada.
Trial summary
This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Viveve - Active and Viveve - Cryogen-Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jan 2020to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.
- Subjects with a BMI of ≤ 35 kg/m².
- 1-hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight
Who cannot join
- Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
- Subjects who are pregnant or plan to become pregnant during the course of the study.
- Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).
- Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].
- Subjects who have started or changed dose of local vaginal hormones <6 weeks before Screening.
- Subjects who have started pelvic floor physical therapy within the last 3 months.
- Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including the Viveve Treatment or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure, and previous dilation and cuterage within 12 months of the subject's Pre-Screening Visit).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Milestone Research
London, Ontario
Bluewater Clinical Research Group
Sarnia, Ontario
Devonshire Clinical Research
Woodstock, Ontario
About this study
This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Viveve - Active, Viveve - Cryogen-Alone, Viveve - Sham
- 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.
Viveve - ActiveDevice
Radiofrequency and Cryogen-Cooling
Viveve - Cryogen-AloneDevice
Cryogen-Cooling
Viveve - ShamDevice
Sham
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Radiofrequency and Cryogen Receives: Device: Viveve - Active |
| Cryogen-Only | Active comparator | Crygen-Only Receives: Device: Viveve - Cryogen-Alone |
| Sham | Sham comparator | Sham comparator Receives: Device: Viveve - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-hour Pad Weight Test
Brief description of test:
- Subject puts on one standardized, pre-weighed pad without voiding.
- Subject drinks 500 mL of sodium-free liquid in < 15 min while sitting or resting.
- 15 - 45 Minutes:
- Subject walks for 30 minutes, including climbing one flight of stairs (up and down).
- 45 - 60 Minutes:
- Subject performs the following activities Standing up from sitting (10 times) Coughing vigorously (10 times) (Subject should be standing) Running on the spot (1 min) Bending to pick up an object from the floor (5 times) • The weight of the pad is measured to determine the amount of leakage.
Measured: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jan 2020
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viveve Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206085
- Sponsor's protocol ID
- VI-19-01
- Status last verified
- May 2020
- First submitted
- 10 Dec 2019
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04206085
- Acronym / sponsor ID
- VI-19-01
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Viveve Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Viveve - ActiveRadiofrequency and Cryogen |
| Cryogen-Only | Active comparator | Device: Viveve - Cryogen-AloneCrygen-Only |
| Sham | Sham comparator | Device: Viveve - ShamSham comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.
- Subjects with a BMI of ≤ 35 kg/m².
- 1-hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight
Key exclusion criteria (7 listed)
- Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
- Subjects who are pregnant or plan to become pregnant during the course of the study.
- Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).
- Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].
- Subjects who have started or changed dose of local vaginal hormones <6 weeks before Screening.
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 |
|---|---|---|
| Viveve - ActiveRadiofrequency and Cryogen-Cooling | Device | Active treatment |
| Viveve - Cryogen-AloneCryogen-Cooling | Device | Cryogen-Only |
| Viveve - ShamSham | Device | Sham |
Primary outcome
1-hour Pad Weight Test
Time frame: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
Brief description of test: * Subject puts on one standardized, pre-weighed pad without voiding. * Subject drinks 500 mL of sodium-free liquid in < 15 min while sitting or resting. • 15 - 45 Minutes: * Subject walks for 30 minutes, including climbing one flight of stairs (up and down). • 45 - 60 Minutes: * Subject performs the following activities Standing up from sitting (10 times) Coughing vigorously (10 times) (Subject should be standing) Running on the spot (1 min) Bending to pick up an object from the floor (5 times) • The weight of the pad is measured to determine the amount of leakage.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viveve - Active and Viveve - Cryogen-Alone in people with Stress Urinary Incontinence, run by Viveve Inc. at 3 sites in Canada.
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 3 inclusion and 7 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
1-hour Pad Weight Test (time frame: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline). 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 21 Sep 2022.