Vaginal Laxity Following ChildbirthVIVEVE INCT02261974
VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
A study testing Active Treatment Viveve in people with Vaginal Laxity Following Childbirth and Sexual Function Following Childbirth, run by Viveve Inc. at 9 sites in 4 countries.
Trial summary
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginal Laxity Following Childbirth, Sexual Function Following Childbirth
- What is being tested?
- Active Treatment Viveve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign the informed consent form
- Pre-menopausal and ≥ 18 years of age
- At least one full term vaginal delivery (> 37 completed weeks gestation) at least 12 months prior to enrollment date
- Experiences vaginal looseness (laxity) during vaginal intercourse
- Subject must have a screening blood count and metabolic panel including FSH level of <35 mIU/mL (35 IU/L).
- Subject must have a normal pelvic exam at baseline and negative chlamydia and gonorrhea cultures during the screening period.
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- Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV.
- Subject must be willing to engage in vaginal intercourse at least once per month.
- Subject must be in a monogamous, heterosexual relationship for at least six months prior to screening visit with a partner who is sexually functional and available at least 50% of the time.
- Subject is surgically sterilized, or is willing to use an acceptable method of birth control that was begun at least 3 month prior to screening and to be continued or throughout the duration of the study [i.e., barrier method (e.g., diaphragm), hormonal therapy (subcutaneous, injectable, or oral contraceptive) intrauterine device], or partner is surgically sterilized
Who cannot join
- Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months.
- Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator, or history of a fourth degree laceration during screening physical exam
- Clinically significant pelvic organ prolapse
- Currently meets the criteria for a female sexual disorder, including DSM V, FSAD, FOD, Genitopelvic Pain, Sexual Aversion, Dyspareunia, or Vaginismus, and has not been treated for this condition within the past 12 months
- Beck Depression Inventory score > 14
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- DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms
- Taking SSNRI or SSRI drugs
- Not willing to abstain from vaginal intercourse or use of tampons until 10-day follow-up visit completed
- Evidence of active sexually transmitted disease upon vaginal exam that precludes treatment
- History of genital herpes
- Clinically significant abnormalities in clinical chemistry or hematology at the time of screening
- Currently taking prescribed medications, OTC products or supplements that may impact or enhance sexual function (e.g., antihypertensive, psychotropic, chemotherapeutic agent, PD5 Inhibitors) as assessed by the investigator
- Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy
- Has an implantable pacemaker, an automatic implantable cardioverter/defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency fields or current
- Has undergone the Viveve Procedure previously
- Has medical condition that in investigator's opinion may interfere with wound healing response
- Has an acute or a chronic vaginal or vulvar disorder (e.g., vaginal atrophy, pain including vulvodynia, vulvar vestibulitis dysethetic vulvodynia or vulvar dystrophy, current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis lichen planus, tinea cruris, lichen sclerosis, seborrhea dermatitis, contact or irritant dermatitis, lichen simplex, eczema) or bullous dermatoses or systemic diseases with potential involvement of vulva)
- Has Irritable Bowel Syndrome or Crohn's Disease
- Has dyspareunia defined as recurrent or persistent painful intercourse that affects sexual activity
- Has been in another clinical study within four weeks of screening, or is not willing to abstain from enrolling in other clinical studies for duration of trial
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Canada4 sites
Allan Centre
Calgary, Alberta, AB T2 7G9
Complexe Medical St-Laurent
Montreal, Quebec, H4R 0B7
Les Cours Medical Centre
Montreal, Quebec, QC H3 A1 T5
Exogenia Institute of Anti-Aging and Regenerative Medicine
Sherbrooke
Japan2 sites
Yokohama Motomachi Jyosei Iryou Clinic Luna
Kanagawa
Naoe Beauty Clinic
Tokyo
Spain2 sites
Instituto Palacios, Salud de la Mujer
Madrid
Unidad de Gestión Clínica de Obstetricia y Ginecología. Hospital Universitario Araba
Vitoria-Gasteiz
Italy1 site
Research Center of Reproductive Medicine. - IRCCS Policlinico San Matteo Hospital
Pavia
About this study
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design
The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.
Read the detailed description
A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is planned. This study is designed to demonstrate that the active treatment (i.e., Viveve Procedure) is superior to the sham treatment for the primary effectiveness and safety endpoints.
Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active treatment group or sham group. The active treatment group will receive a treatment dose of 90 J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.
Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post treatment.
Final data will be reported at 6 months for active and sham treatments.
- Being tested
- Active Treatment Viveve, Sham Treatment Viveve
- Keywords
- Vaginal laxity, Sexual Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Treatment ViveveDevice
Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus
Sham Treatment ViveveDevice
Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
| Study group | Role | What they receive |
|---|---|---|
| Active Viveve Treatment | Active comparator | Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Receives: Device: Active Treatment Viveve |
| Sham Viveve Treatment | Placebo comparator | Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Receives: Device: Sham Treatment Viveve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score
The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.
Measured: 6 months
Reporting Adverse Events (AEs)
Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.
Measured: 6 months
Secondary outcomes (3)
Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score
Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity ("looseness") and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.
Measured: 6 months
Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)
Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = "Very Loose" and 7 = "Very Tight". The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.
Measured: 6 months
Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)
The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a "worse outcome". The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginal Laxity Following ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viveve Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debbie Wilkerson, PhD, Study director, Viveve Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261974
- Sponsor's protocol ID
- (OUS) V-013
- Acronym
- VIVEVE I
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2014
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
- ClinicalTrials.gov ID
- NCT02261974
- Acronym / sponsor ID
- VIVEVE I / (OUS) V-013
- Keywords
- Vaginal laxity, Sexual Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Viveve Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 27 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design
The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.
Detailed description
A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is planned. This study is designed to demonstrate that the active treatment (i.e., Viveve Procedure) is superior to the sham treatment for the primary effectiveness and safety endpoints.
Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active treatment group or sham group. The active treatment group will receive a treatment dose of 90 J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.
Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post treatment.
Final data will be reported at 6 months for active and sham treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Viveve Treatment | Active comparator | Device: Active Treatment ViveveIntervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus |
| Sham Viveve Treatment | Placebo comparator | Device: Sham Treatment ViveveIntervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to understand and voluntarily sign the informed consent form
- Pre-menopausal and ≥ 18 years of age
- At least one full term vaginal delivery (> 37 completed weeks gestation) at least 12 months prior to enrollment date
- Experiences vaginal looseness (laxity) during vaginal intercourse
- Subject must have a screening blood count and metabolic panel including FSH level of <35 mIU/mL (35 IU/L).
Key exclusion criteria (21 listed)
- Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months.
- Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator, or history of a fourth degree laceration during screening physical exam
- Clinically significant pelvic organ prolapse
- Currently meets the criteria for a female sexual disorder, including DSM V, FSAD, FOD, Genitopelvic Pain, Sexual Aversion, Dyspareunia, or Vaginismus, and has not been treated for this condition within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Treatment ViveveSubject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus | Device | Active Viveve Treatment |
| Sham Treatment ViveveSubject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus | Device | Sham Viveve Treatment |
Primary outcome
Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score
Time frame: 6 months
The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.
Reporting Adverse Events (AEs)
Time frame: 6 months
Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.
3 secondary outcomes
Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score
Time frame: 6 months
Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)
Time frame: 6 months
Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie Wilkerson, PhD study director
Viveve Inc.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Treatment Viveve in people with Vaginal Laxity Following Childbirth and Sexual Function Following Childbirth, run by Viveve Inc. at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, Japan, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.