Efficacy of a combined multi-polar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, controlled trial

Phase 4

Completed

• Conditions: vaginal laxity; Multi- polar; Radiofrequency; Pulsed Electromagnetic Field Technology; Vaginal Laxity

• Registration Number: TCTR20200803002
• Lead Sponsor: Division of Dermatology, Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-29
• Study Start: 2020-08-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Inclusion criteria consisted of self-reported of vaginal laxity defined as “very loose”, “moderately loose”, 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vaginal laxity 12 weeks (Vaginal Laxity Questionnaire; VLQ)

Secondary Outcome Measures

Name	Time	Method
vaginal laxity 12 weeks Brink scale, perineometer, Female Sexual Function Index Questionnaire, Visual Analog Scale, 10-poi