Stress Urinary Incontinence
Conditions
Keywords
incontinence, urine, urinary, pee, leak, SUI
Brief summary
This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.
Detailed description
Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.
Interventions
DEVICEViveve Treatment
The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
Sponsors
Viveve Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Signed and dated ICF * Pre-menopausal females * Documented diagnosis of SUI
Exclusion criteria
* Pregnant or planning to become pregnant within the year * Undergone other SUI treatments (excluding Kegels)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CFB in 1-hour Pad Weight Test | 6 months post-treatment | Change from baseline in the 1-hour pad weight test to 6 months post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Event Reporting | 6 months post-treatment | Safety as assessed by Adverse Event reporting |
Other
| Measure | Time frame | Description |
|---|---|---|
| I-QOL | 6 months post-treatment | Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL) |
| UDI-6 | 6 months post-treatment | 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. |
| Voiding Episodes Per Day | 6 months post-treatment | Voiding episodes per day tracked via daily voiding diary. |
| FSFI | 6 months post-treatment | Validated questionnaire titled The Female Sexual Function Index (FSFI) |
| ICIQ-UI-SF | 6 months post-treatment | Validated urinary incontinence questionnaire titled International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) |
Countries
Canada
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Active Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse). | 66 |
| Sham Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (\<1 J/cm2) and Cryogen Cooling (35 ms pulse). | 33 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discomfort during treatment | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Sham | Active |
|---|---|---|---|
| 1 Hour Pad Weight | 12.9 grams | 12.9 grams | 12.8 grams |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 5.22 | 42.3 years STANDARD_DEVIATION 4.67 | 42.8 years STANDARD_DEVIATION 5.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 89 Participants | 30 Participants | 59 Participants |
| Region of Enrollment Canada | 99 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 99 Participants | 33 Participants | 66 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Urinary Distress Inventory (UDI6) | 55.6 units on a scale | 55.6 units on a scale | 55.6 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 33 |
| other Total, other adverse events | 0 / 66 | 2 / 33 |
| serious Total, serious adverse events | 2 / 66 | 1 / 33 |
Outcome results
Primary
CFB in 1-hour Pad Weight Test
Change from baseline in the 1-hour pad weight test to 6 months post-treatment.
Time frame: 6 months post-treatment
Population: Full Analysis Set: randomized subjects in the with non-missing values at the timepoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active | CFB in 1-hour Pad Weight Test | -8.1 grams |
| Sham | CFB in 1-hour Pad Weight Test | -8.1 grams |
Secondary
Safety and Adverse Event Reporting
Safety as assessed by Adverse Event reporting
Time frame: 6 months post-treatment
Population: Adverse events are reported in the AE section.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Safety and Adverse Event Reporting | 24 Participants |
| Sham | Safety and Adverse Event Reporting | 14 Participants |
Other Pre-specified
FSFI
Validated questionnaire titled The Female Sexual Function Index (FSFI)
Time frame: 6 months post-treatment
Other Pre-specified
ICIQ-UI-SF
Validated urinary incontinence questionnaire titled International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
Time frame: 6 months post-treatment
Other Pre-specified
I-QOL
Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL)
Time frame: 6 months post-treatment
Other Pre-specified
UDI-6
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.
Time frame: 6 months post-treatment
Population: Full Analysis Set: randomized subjects non-missing values at the timepoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active | UDI-6 | -22.2 units on a scale |
| Sham | UDI-6 | -16.7 units on a scale |
Other Pre-specified
Voiding Episodes Per Day
Voiding episodes per day tracked via daily voiding diary.
Time frame: 6 months post-treatment