Trial Outcomes & Findings for LIBERATE International (NCT NCT03619174)

NCT ID: NCT03619174

Last Updated: 2022-09-21

Results Overview

Change from baseline in the 1-hour pad weight test to 6 months post-treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

99 participants

Primary outcome timeframe

6 months post-treatment

Results posted on

2022-09-21

Participant Flow

Subjects completed prescreening and screening visits to assess their level of SUI, perform physical exam to assess their condition and collected initial patient reported outcome data.

Participant milestones

Participant milestones
Measure	Active Treatment Treatment dose Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham Treatment Sub-therapeutic dose Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
Overall Study STARTED	66	33
Overall Study COMPLETED	57	29
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment Treatment dose Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham Treatment Sub-therapeutic dose Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	4	3
Overall Study Pregnancy	1	1
Overall Study Discomfort during treatment	1	0

Baseline Characteristics

LIBERATE International

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=66 Participants Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham n=33 Participants Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).	Total n=99 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 5.51 • n=5 Participants	42.3 years STANDARD_DEVIATION 4.67 • n=7 Participants	42.6 years STANDARD_DEVIATION 5.22 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	33 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	30 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	66 participants n=5 Participants	33 participants n=7 Participants	99 participants n=5 Participants
1 Hour Pad Weight	12.8 grams n=5 Participants	12.9 grams n=7 Participants	12.9 grams n=5 Participants
Urinary Distress Inventory (UDI6)	55.6 units on a scale n=5 Participants	55.6 units on a scale n=7 Participants	55.6 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-treatment

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

Change from baseline in the 1-hour pad weight test to 6 months post-treatment.

Outcome measures

Outcome measures
Measure	Active n=56 Participants Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham n=29 Participants Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
CFB in 1-hour Pad Weight Test	-8.1 grams Interval -18.5 to -5.7	-8.1 grams Interval -16.6 to -4.4

SECONDARY outcome

Timeframe: 6 months post-treatment

Population: Adverse events are reported in the AE section.

Safety as assessed by Adverse Event reporting

Outcome measures

Outcome measures
Measure	Active n=66 Participants Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham n=33 Participants Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
Safety and Adverse Event Reporting	24 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-treatment

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

Validated urinary incontinence questionnaire titled Urogenital Distress Inventory-6 (UDI-6). UDI-6 contains 6 items about urinary problems. Each item is scored between 0 (no problem) to 3 (bothered greatly). All scores are summed, divided by 18 and then multiplied by 100 for the scale score. Minimum scale score is 0 and maximum is 100. Higher score indicates higher disability. Efficacy measure of change from baseline to 3- and 6- months post-treatment in UDI-6.

Outcome measures

Outcome measures
Measure	Active n=56 Participants Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham n=29 Participants Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
UDI-6	-22.2 units on a scale Interval -38.9 to -5.6	-16.7 units on a scale Interval -33.3 to -5.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-treatment

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Treatment n=66 participants at risk Treatment dose Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham Treatment n=33 participants at risk Sub-therapeutic dose Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
Injury, poisoning and procedural complications Right Ankle Fracture	1.5% 1/66 • Number of events 1 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.	0.00% 0/33 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.
Cardiac disorders Angina Pectoris	1.5% 1/66 • Number of events 1 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.	0.00% 0/33 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.
Congenital, familial and genetic disorders Freeman-Sheldon Syndrome	0.00% 0/66 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.	3.0% 1/33 • Number of events 1 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.

Other adverse events

Other adverse events
Measure	Active Treatment n=66 participants at risk Treatment dose Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse).	Sham Treatment n=33 participants at risk Sub-therapeutic dose Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse).
Gastrointestinal disorders Abdominal Pain	0.00% 0/66 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.	6.1% 2/33 • Number of events 33 • Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject. Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.

Additional Information

Vice President, Clinical & Medical Affairs

Viveve

Phone: 720-696-8173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place