vaginal laxity Multi-
Conditions
Interventions
Treatment group received treatment at an RF energy level up to 55% and a target therapeutic temperature level of 40-
41°C for the proximal (closest to the applicator base) pair of electrodes while for the mid and distal (furthest from the applicator base) pairs of electrodes the energy level was adjusted to 65% a
45°C.Duration of each treatment was approximately 15 minutes. ,Sham group received treatment at an RF energy level 0% for all three pairs of electrodes. Duration of each treatment was approximately
(multipolar RF with PEMF) treatment ,Sham treatment.
Sponsors
Division of Dermatology, Ramathibodi Hospital
Division of Dermatology,
Ramathibodi Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria consisted of self-reported of vaginal laxity defined as “very looseâ€, “moderately looseâ€, or “slightly loose†assessed by Vaginal Laxity Questionnaire (VLQ) score, normal Papanicolou smear cytology, negative pregnancy test within 2 months, willingness to participate in vaginal intercourse at least two times per month and be either surgically sterilized or willing to use an acceptable method of birth control at least one month before screening and throughout the duration of study
Exclusion criteria
Exclusion criteria: Women were excluded from the trial if they had evidence of pelvic organ prolapse beyond the hymenal ring, an active sexually transmitted disease, urinary tract infection, those with clinically active lesion around vagina, cervix, labia majora, labia minora and clitoris, those with history of surgical vaginal repair, those taking medications known to affect collagen remodeling and healing process (eg. NSAIDS, steroid) within 1 month prior to treatment. However, those subjects who were on oral contraceptives prior to enrollment continued to take these pills throughout the study were not excluded. All pregnant and breastfeeding women, severe or uncontrolled underlying disease, unable to follow-up according to the study protocol led to exclusion of candidates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal laxity 12 weeks (Vaginal Laxity Questionnaire; VLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| vaginal laxity 12 weeks Brink scale, perineometer, Female Sexual Function Index Questionnaire, Visual Analog Scale, 10-poi | — |
Countries
Thailand
Contacts
Public ContactPenpun Wattanakrai
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed