NCT04206085

Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence

Completed NA Results posted Last updated 21 September 2022

What this trial tests

NA trial testing Viveve - Active in Stress Urinary Incontinence in 38 participants. Completed in 30 August 2020.

Timeline

1 January 2020

Primary endpoint
30 August 2020

30 August 2020

Quick facts

Lead sponsor	Viveve Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	38
Start date	1 January 2020
Primary completion	30 August 2020
Estimated completion	30 August 2020
Sites	3 locations across Canada

Drugs / interventions tested

• Viveve - Active
• Viveve - Cryogen-Alone
• Viveve - Sham

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Viveve Inc.

Who can join

18 and older, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

1-hour Pad Weight Test Primary · 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 le

Group	Value	95% CI
Active Treatment	-9.0	-10.1 – -5.8
Cryogen-Only	-6.3	-20.6 – -1.8
Sham	-4.4	-5.0 – 2.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Arm

Serious: 0/13 (0%)

Deaths: 0/13

Cryogen Arm

Serious: 0/13 (0%)

Deaths: 0/13

Sham Arm

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (16 terms — click to expand)

Reaction	System	Active Arm	Cryogen Arm	Sham Arm
Diarrhoea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—
Medical device site irritation	General disorders	—	—	—
Asthma	Immune system disorders	—	—	—
Hypersensitivity	Immune system disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	—	—	—
Tension headache	Nervous system disorders	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—
Pelvic Pain	Reproductive system and breast disorders	—	—	—
Vulvovaginal discomfort	Reproductive system and breast disorders	—	—	—
Pelvic Discomfort	Reproductive system and breast disorders	—	—	—

Data from ClinicalTrials.gov NCT04206085 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.