Trial Outcomes & Findings for Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence (NCT NCT04206085)

NCT ID: NCT04206085

Last Updated: 2022-09-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

Change in 1 hour Pad Weight Test Values at 5 Months from Baseline

Results posted on

2022-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Active Treatment Radiofrequency and Cryogen Viveve - Active: Radiofrequency and Cryogen-Cooling	Cryogen-Only Crygen-Only Viveve - Cryogen-Alone: Cryogen-Cooling	Sham Sham comparator Viveve - Sham: Sham
Overall Study STARTED	13	13	12
Overall Study COMPLETED	13	12	11
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment Radiofrequency and Cryogen Viveve - Active: Radiofrequency and Cryogen-Cooling	Cryogen-Only Crygen-Only Viveve - Cryogen-Alone: Cryogen-Cooling	Sham Sham comparator Viveve - Sham: Sham
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

12 in cryogen alone arm analyzed in full analysis set. 11 in sham arm analyzed in full analysis set.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=13 Participants Radiofrequency and Cryogen Viveve - Active: Radiofrequency and Cryogen-Cooling	Cryogen-Only n=13 Participants Crygen-Only Viveve - Cryogen-Alone: Cryogen-Cooling	Sham n=12 Participants Sham comparator Viveve - Sham: Sham	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants	13 Participants n=13 Participants	12 Participants n=12 Participants	38 Participants n=38 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Age, Continuous	42.6 years STANDARD_DEVIATION 9.02 • n=13 Participants • 12 in cryogen alone arm analyzed in full analysis set. 11 in sham arm analyzed in full analysis set.	42.6 years STANDARD_DEVIATION 7.38 • n=12 Participants • 12 in cryogen alone arm analyzed in full analysis set. 11 in sham arm analyzed in full analysis set.	43.3 years STANDARD_DEVIATION 6.50 • n=11 Participants • 12 in cryogen alone arm analyzed in full analysis set. 11 in sham arm analyzed in full analysis set.	42.8 years STANDARD_DEVIATION 7.56 • n=36 Participants • 12 in cryogen alone arm analyzed in full analysis set. 11 in sham arm analyzed in full analysis set.
Sex: Female, Male Female	13 Participants n=13 Participants	13 Participants n=13 Participants	12 Participants n=12 Participants	38 Participants n=38 Participants
Sex: Female, Male Male	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Black or African American	0 Participants n=13 Participants	0 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=38 Participants
Race (NIH/OMB) White	13 Participants n=13 Participants	13 Participants n=13 Participants	11 Participants n=12 Participants	37 Participants n=38 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=38 Participants
Region of Enrollment Canada	13 participants n=13 Participants	13 participants n=13 Participants	12 participants n=12 Participants	38 participants n=38 Participants

PRIMARY outcome

Timeframe: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline

Population: Full analysis set used.

Outcome measures

Outcome measures
Measure	Active Treatment n=13 Participants Radiofrequency and Cryogen Viveve - Active: Radiofrequency and Cryogen-Cooling	Cryogen-Only n=12 Participants Crygen-Only Viveve - Cryogen-Alone: Cryogen-Cooling	Sham n=11 Participants Sham comparator Viveve - Sham: Sham
1-hour Pad Weight Test	-9.0 Grams Interval -10.1 to -5.8	-6.3 Grams Interval -20.6 to -1.8	-4.4 Grams Interval -5.0 to 2.8

Adverse Events

Active Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cryogen Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Vice President, Clinical & Medical Affairs

Viveve

Phone: 720-696-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active Arm n=13 participants at risk 90 J/cm2 radiofrequency, 35 ms pulse cryogen cooling)	Cryogen Arm n=13 participants at risk \<1 J/cm2 radiofrequency, 35 ms pulse cryogen cooling	Sham Arm n=12 participants at risk Completely inert tip
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	8.3% 1/12 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
General disorders Medical device site irritation	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Immune system disorders Asthma	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Immune system disorders Hypersensitivity	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Infections and infestations Nasopharyngitis	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Infections and infestations Bronchitis	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	8.3% 1/12 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Infections and infestations Urinary Tract Infection	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Injury, poisoning and procedural complications Fall	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	8.3% 1/12 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Nervous system disorders Tension headache	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Renal and urinary disorders Pollakiuria	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	8.3% 1/12 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Reproductive system and breast disorders Pelvic Pain	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Reproductive system and breast disorders Vulvovaginal discomfort	7.7% 1/13 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/12 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.
Reproductive system and breast disorders Pelvic Discomfort	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	0.00% 0/13 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.	8.3% 1/12 • Number of events 1 • For each subject, adverse event collection occurred from treatment initiation at the randomization visit until the completion of the month 5 visit. The duration was 5 months.