CompletedNot Applicable

VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Canada, Italy, Japan186 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score

Timeframe: 6 months

Reporting Adverse Events (AEs)

Timeframe: 6 months

Trial details

NCT IDNCT02261974

SponsorViveve Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2017-03-27

View on ClinicalTrials.gov More Vaginal Laxity Following Childbirth trials

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV.

VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria