Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vul… (NCT04511260) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
United States20 participantsStarted 2020-10-16
Plain-language summary
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
Who can participate
Age range35 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women age between 35 to 60
* Last vaginal delivery is at least 12 months prior to enrollment
* Self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the Vaginal Laxity Questionnaire (VLQ)
* Sexual activity≥ once per month, with a same partner
* Willing to use contraception for the duration of the study
* Negative urine analysis
* Negative pregnancy test
* Patient is not pregnant nor planning to become pregnant throughout the duration of the study
* Willing to improve vaginal lips / genitals appearance (optional)
* Normal gynecological exam from the recent year
* If taking probiotics and/or any other supplement or suppository as part of daily regimen, willing to maintain same regimen throughout the entire duration of the study
* Able and willing to comply with the treatment/follow-up schedule and requirements ·
* Willing to sign an informed consent
Exclusion Criteria:
* Previous pelvic floor reconstructive surgery with mesh.
* Pelvic organ prolapse (POP) \>II according to the pelvic organ prolapse quantification system
* Pregnant or lactating
* Women in post-menopausal stage for more than five years.
* Active genital infection or sexually transmitted diseases
* Subject presenting abnormal Pap smear result from the last five years with any of the following findings according to the Bethesda System (2001) classification: A.. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion B. Aty…
What they're measuring
1
Safety and Efficacy of the NuEra small area handpiece