Stress Urinary IncontinenceNCT03619174

LIBERATE International

A study testing Viveve Treatment in people with Stress Urinary Incontinence, run by Viveve Inc. at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham. 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 Treatment
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 6 sitesCanada
Study dates: 8 Aug 2018to 5 Jul 2019
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

Signed and dated ICF
Pre-menopausal females
Documented diagnosis of SUI

Who cannot join

Pregnant or planning to become pregnant within the year
Undergone other SUI treatments (excluding Kegels)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Canada6 sites

LIBERATE Int'l Site
Burlington, Ontario
LIBERATE Int'l Site
London, Ontario
LIBERATE Int'l Site
Pointe-Claire, Montreal
LIBERATE Int'l Site
Sarnia, Ontario
LIBERATE Int'l Site
Toronto, Ontario
LIBERATE In't Site
Vancouver, British Columbia

Other trials in Canada

About this study

Official title: LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence

Read the detailed description

Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.

Conditions: Stress Urinary Incontinence
Being tested: Viveve Treatment
Keywords: incontinence, urine, urinary, pee, leak, SUI
Medical subject headings: Urinary Incontinence, Stress, Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Viveve TreatmentDevice
The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.

Study groups in NCT03619174
Study group	Role	What they receive
Active Treatment	Active comparator	Treatment dose Receives: Device: Viveve Treatment
Sham Treatment	Placebo comparator	Sub-therapeutic dose Receives: Device: Viveve Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

CFB in 1-hour Pad Weight Test
Change from baseline in the 1-hour pad weight test to 6 months post-treatment.
Measured: 6 months post-treatment

Secondary outcomes (1)

Safety and Adverse Event Reporting
Safety as assessed by Adverse Event reporting
Measured: 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 20185 Jul 2019

First posted7 Aug 2018
Study start8 Aug 2018
Primary completion5 Jul 2019
Study completion5 Jul 2019

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03619174
Sponsor's protocol ID: LIBERATE International
Status last verified: Jul 2019
First submitted: 26 Jul 2018
Last updated: 21 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stress Urinary Incontinence trials

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: LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT03619174
Acronym / sponsor ID: LIBERATE International
Conditions: Stress Urinary Incontinence
Keywords: incontinence, urine, urinary, pee, leak, SUI
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Viveve Inc.Industry (pharma, biotech, devices)
Study start: 8 Aug 2018 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 7 Aug 2018 (actual)
Results: Posted 18 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Treatment	Active comparator	Device: Viveve TreatmentTreatment dose
Sham Treatment	Placebo comparator	Device: Viveve TreatmentSub-therapeutic dose

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)

Signed and dated ICF
Pre-menopausal females
Documented diagnosis of SUI

Key exclusion criteria (2 listed)

Pregnant or planning to become pregnant within the year
Undergone other SUI treatments (excluding Kegels)

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 TreatmentThe Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.	Device	Active Treatment, Sham Treatment

Primary outcome

CFB in 1-hour Pad Weight Test
Time frame: 6 months post-treatment
Change from baseline in the 1-hour pad weight test to 6 months post-treatment.

1 secondary outcome

Safety and Adverse Event Reporting
Time frame: 6 months post-treatment

Results and safety

Results posted to the registry on 18 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	66	57
Sham Treatment	33	29

Primary outcome: CFB in 1-hour Pad Weight Test

Time frame: 6 months post-treatment. Median (Inter-Quartile Range). Unit: grams

Measure	Active n = 56	Sham n = 29
Value	-8.1 (-18.5 to -5.7)	-8.1 (-16.6 to -4.4)

Population analysed: Full Analysis Set: randomized subjects in the with non-missing values at the timepoint.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	2 of 66 (3%)	0 of 66 (0%)	0 of 66
Sham Treatment	1 of 33 (3%)	2 of 33 (6.1%)	0 of 33

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

Related trials for Stress Urinary Incontinence

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Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
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Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
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Active, not recruiting
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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.

Stacie Bell, PhD study director

Viveve Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Viveve Treatment in people with Stress Urinary Incontinence, run by Viveve Inc. at 6 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 2 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 6 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 18 Aug 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?

CFB in 1-hour Pad Weight Test (time frame: 6 months post-treatment). 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 NCT03619174.

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.