Stress Urinary Incontinence
Conditions
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.
Interventions
DEVICEViveve - Active
Radiofrequency and Cryogen-Cooling
DEVICEViveve - Cryogen-Alone
Cryogen-Cooling
DEVICEViveve - Sham
Sham
Sponsors
Viveve Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-hour Pad Weight Test | 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 leakage. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Radiofrequency and Cryogen
Viveve - Active: Radiofrequency and Cryogen-Cooling | 13 |
| Cryogen-Only Crygen-Only
Viveve - Cryogen-Alone: Cryogen-Cooling | 13 |
| Sham Sham comparator
Viveve - Sham: Sham | 12 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cryogen-Only | Sham | Total | Active Treatment |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 38 Participants | 13 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 7.38 | 43.3 years STANDARD_DEVIATION 6.5 | 42.8 years STANDARD_DEVIATION 7.56 | 42.6 years STANDARD_DEVIATION 9.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 11 Participants | 37 Participants | 13 Participants |
| Region of Enrollment Canada | 13 participants | 12 participants | 38 participants | 13 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 38 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 8 / 13 | 2 / 13 | 4 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 12 |
Outcome results
Primary
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.
Time frame: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
Population: Full analysis set used.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Treatment | 1-hour Pad Weight Test | -9.0 Grams |
| Cryogen-Only | 1-hour Pad Weight Test | -6.3 Grams |
| Sham | 1-hour Pad Weight Test | -4.4 Grams |