Back to resultsComparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Viveve - Active
Viveve - Cryogen-Alone
Viveve - Sham
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- Milestone Research
- Bluewater Clinical Research Group
- Devonshire Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Active treatment
Cryogen-Only
Sham
Arm Description
Radiofrequency and Cryogen
Crygen-Only
Sham comparator
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04206085
Brief Title
Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
Official Title
Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viveve Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Experimental
Arm Description
Radiofrequency and Cryogen
Arm Title
Cryogen-Only
Arm Type
Active Comparator
Arm Description
Crygen-Only
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham comparator
Intervention Type
Device
Intervention Name(s)
Viveve - Active
Intervention Description
Radiofrequency and Cryogen-Cooling
Intervention Type
Device
Intervention Name(s)
Viveve - Cryogen-Alone
Intervention Description
Cryogen-Cooling
Intervention Type
Device
Intervention Name(s)
Viveve - Sham
Intervention Description
Sham
Primary Outcome Measure Information:
Title
1-hour Pad Weight Test
Description
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.
Time Frame
Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Facility Information:
Facility Name
Milestone Research
City
London
State/Province
Ontario
Country
Canada
Facility Name
Bluewater Clinical Research Group
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Devonshire Clinical Research
City
Woodstock
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham Treatment for Stress Urinary Incontinence
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