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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active Comparator | Treatment dose |
|
| Sham Treatment | Placebo Comparator | Sub-therapeutic dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viveve Treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CFB in 1-hour Pad Weight Test | Change from baseline in the 1-hour pad weight test to 6 months post-treatment. | 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Event Reporting | Safety as assessed by Adverse Event reporting | 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Key Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie Bell, PhD | Viveve Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LIBERATE In't Site | Vancouver | British Columbia | Canada | |||
| LIBERATE Int'l Site |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Treatment dose Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse). |
| FG001 | Sham Treatment | Sub-therapeutic dose Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (<1 J/cm2) and Cryogen Cooling (35 ms pulse). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse). |
| BG001 | Sham | Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (<1 J/cm2) and Cryogen Cooling (35 ms pulse). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years, including full years and tenths of years was collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CFB in 1-hour Pad Weight Test | Change from baseline in the 1-hour pad weight test to 6 months post-treatment. | Full Analysis Set: randomized subjects in the with non-missing values at the timepoint. | Posted | Median | Inter-Quartile Range | grams | 6 months post-treatment |
|
Treatment Emergent Adverse Events reporting occurred from the treatment procedure to study completion (up to 6 months post treatment) for each subject.
Treatment emergent adverse events were evaluated in 66 Active Treatment subjects and 33 Sham Treatment subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Treatment dose Viveve Active Treatment: comprised of therapeutic levels of Radiofrequency (90 J/cm2) and Cryogen Cooling (35 ms pulse). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Non-systematic Assessment | Subject received active treatment. Experienced a right ankle fracture 50 days after treatment that resulted in hospitalization. The event was coded as unrelated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical & Medical Affairs | Viveve | 720-696-8173 | clinicalaffairs@viveve.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2018 | Apr 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2019 | Apr 7, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2018 | Jun 7, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 6 months post-treatment |
| ICIQ-UI-SF | Validated urinary incontinence questionnaire titled International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) | 6 months post-treatment |
| I-QOL | Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL) | 6 months post-treatment |
| FSFI | Validated questionnaire titled The Female Sexual Function Index (FSFI) | 6 months post-treatment |
| Voiding Episodes Per Day | Voiding episodes per day tracked via daily voiding diary. | 6 months post-treatment |
| Pointe-Claire |
| Montreal |
| Canada |
| LIBERATE Int'l Site | Burlington | Ontario | Canada |
| LIBERATE Int'l Site | London | Ontario | Canada |
| LIBERATE Int'l Site | Sarnia | Ontario | Canada |
| LIBERATE Int'l Site | Toronto | Ontario | Canada |
| Pregnancy |
|
| Discomfort during treatment |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 1 Hour Pad Weight | The 1-hour Pad Weight Test was published by Khrut in 2014). It is a 60 minute procedure that measures the severity of urinary incontinence. It consists of the following:
The weight of the pad is measured to determine the amount of leakage. | Median | Inter-Quartile Range | grams |
|
| Urinary Distress Inventory (UDI6) | 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 scores indicate higher disability. | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Safety and Adverse Event Reporting | Safety as assessed by Adverse Event reporting | Adverse events are reported in the AE section. | Posted | Count of Participants | Participants | 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. | Full Analysis Set: randomized subjects non-missing values at the timepoint. | Posted | Median | Inter-Quartile Range | units on a scale | 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) | Not Posted | 6 months post-treatment | Participants |
| Other Pre-specified | I-QOL | Validated urinary incontinence questionnaire titled Incontinence Quality of Life (I-QOL) | Not Posted | 6 months post-treatment | Participants |
| Other Pre-specified | FSFI | Validated questionnaire titled The Female Sexual Function Index (FSFI) | Not Posted | 6 months post-treatment | Participants |
| Other Pre-specified | Voiding Episodes Per Day | Voiding episodes per day tracked via daily voiding diary. | Not Posted | 6 months post-treatment | Participants |
| 0 |
| 66 |
| 2 |
| 66 |
| 0 |
| 66 |
| EG001 | Sham Treatment | Sub-therapeutic dose Viveve Sham Treatment: comprised of non-therapeutic level of Radiofrequency (<1 J/cm2) and Cryogen Cooling (35 ms pulse). | 0 | 33 | 1 | 33 | 2 | 33 |
|
| Angina Pectoris | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment | Subject received active treatment. Experienced Angina Pectoris 108 days after treatment which resulted in hospitalization. Event coded as not related. |
|
| Freeman-Sheldon Syndrome | Congenital, familial and genetic disorders | MedDRA Version 22.0 | Systematic Assessment | Subject was treated with Sham. Became pregnant during the trial and delivered a child with Freeman-Sheldon Syndrome. Pregnancy occurred approximately 60 days post treatment and was coded as not related. |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |