VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness (NCT02261974) | Clinical Trial Compass
CompletedNot Applicable
VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
Canada, Italy186 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 range18 Years – 65 Years
SexFEMALE
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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.
✓. Subject must be willing to engage in vaginal intercourse at least once per month.
Exclusion criteria
✕. 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
✕
What they're measuring
1
Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score
✕. 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