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Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women

NCT06872281 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-03-17

No results posted yet for this study

Summary

Knowledge gap: Lack of randomized controlled trials evaluating the efficacy of fractional bipolar radiofrequency therapy compared to a sham treatment for vaginal laxity in premenopausal women.

Primary outcomes

* Subjective outcomes: The Vaginal Laxity Questionnaire (VLQ) Secondary outcomes
* Subjective outcomes

* The Thai version of the Female Sexual Function Index (FSFI) will be administered to evaluate sexual function.
* The Thai version of the Female Genital Self-Image Scale (FGSIS)
* The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), validated in Thai
* The Patient Global Impression of Improvement (PGI-I)
* Patients will report any side effects or adverse events experienced during the study.
* Objective outcomes - Vaginal wall thickness will be assessed using 3D transvaginal ultrasound imaging, following the standardized protocol established in previous studies.

PICO:

P (Population): Premenopausal women with clinically diagnosed vaginal laxity who are sexually active.

I (Intervention): Fractional bipolar radiofrequency therapy (single treatment)

C (Comparison): Sham treatment (placebo).

O (Outcomes):

* Primary Outcome: Improvement in vaginal laxity as assessed by the Vaginal Laxity Questionnaire (VLQ).
* Secondary Outcomes: Patient satisfaction with treatment (measured by the Patient Global Impression of Improvement - PGI-I)., Changes in sexual function (assessed using the Thai version of the Female Sexual Function Index - FSFI).

Perception of genital self-image (evaluated using the Thai version of the Female Genital Self-Image Scale - FGSIS)., Evaluation of vaginal symptoms (using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms - ICIQ-VS), Objective assessment of vaginal wall thickness through 3D transvaginal ultrasound, Recording of any side effects or adverse events associated with the treatment.

Study Design:

A double-blind, randomized controlled trial (RCT) conducted at the Female Pelvic Medicine and Reconstructive Surgery clinic in Ramathibodi Hospital.

Conditions

  • Vaginal Laxity

Interventions

DEVICE

Fractional bipolar radiofrequency

The treatment group will receive a single treatment of intravaginal fractional bipolar radiofrequency therapy.

DEVICE

Sham device

The sham group will receive treatment with a specialized sham device that mimics the treatment group's equipment. There are no differences in the design of the tip device, the auditory signal (beeping), or the pulse count display.

Sponsors & Collaborators

  • InMode MD Ltd.

    collaborator INDUSTRY

  • Mahidol University

    lead OTHER

Principal Investigators

  • Suthanud Premchit, MD · Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-10-31
Completion
2025-11-30
FDA Device
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06872281 on ClinicalTrials.gov