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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-55
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Premenopausal women

Age 20-55 years

Reported symptoms of vaginal looseness with a score of at least 1 on The Vaginal Laxity Questionnaire (VLQ)

Sexually active (≥1 time/month)

Disqualifiers

- Presence of sexually transmitted diseases or active genital lesions

Currently pregnant or planning for conception during study period

Pelvic organ prolapse (POP ≥ Stage II)

Previous treatment for vaginal laxity with modalities other than pelvic floor muscle training

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fractional bipolar radiofrequency

    Device

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

  • Sham device

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Intervention (fractional bipolar radiofrequency therapy)Active comparator 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Vaginal Laxity Questionnaire (VLQ)

Subjective outcomes * The Vaginal Laxity Questionnaire (VLQ) will be used to assess patient-reported vaginal laxity. * A score of 1-3 indicates positive for vaginal laxity (1 = severe, 2 = moderate, 3 = mild symptom). * A score of 4-7 indicates no vaginal laxity, with 7 representing the greatest vaginal tightness. * A higher VLQ score post-treatment reflects improvement in vaginal laxity.

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Subjective outcomes: The Patient Global Impression of Improvement (PGI-I)

The Patient Global Impression of Improvement (PGI-I) will measure overall patient satisfaction with treatment outcomes. It is a global index used to assess the response of vaginal laxity to therapy. The PGI-I is a single-question transition scale asking patients to rate their vaginal laxity condition compared to before treatment, on a scale from 1 (very much better) to 7 (very much worse).

Time frame
From 4-week post-treatment to the end of the 12-week treatment period
2

Subjective outcome: Patient-reported adverse events

Patients will report any side effects or adverse events experienced during the study. * Pain or discomfort will be assessed using "a visual analog scale" from 0 to 10 (0 = no pain, 10 = worst pain). * Other adverse events, such as abnormal vaginal bleeding, abnormal vaginal discharge, vaginal burning sensation, and dyspareunia, will be reported as yes (if present) or no (if not present)

Time frame
From post-treatment to the end of the 12-week treatment period
3

Subjective outcome: The Thai version of the Female Sexual Function Index (FSFI)

The FSFI comprises of a 19-item questionnaire focused on sexual functioning. There are 6 domain scores (desire, arousal, lubrication, orgasm, satisfaction, pain) belonging to the FSFI and that are summed to obtain the overall score. The rule of thumb for the overall result is that scores equal to or below 26.55 are classed as indicating female sexual dysfunction (FSD). The domain scores are derived from the multiplication of the sum of domain items points and the domain factor. By adding the six domains, the final result can be obtained. Usually, for domains in which the score is zero, this is indicative of the subject having reported there was no sexual activity during the past 4 weeks.

Time frame
From enrollment to the end of treatment at 12 weeks
4

Subjective outcome: The Thai version of the Female Genital Self-Image Scale (FGSIS)

The FGSIS score stands for the Female Genital Self-Image Scale. It is used to assess how women perceive their genitalia and can provide insight into their satisfaction, body image, and how these factors may impact sexual function and health-related quality of life. The FGSIS includes a series of statements or questions, usually answered on a 4-point or 5-point Likert scale, with responses such as: * Strongly Disagree * Disagree * Neutral * Agree * Strongly Agree Total Score: • The responses are totaled to give an overall score. Interpretation of Scores: * Low Scores: These suggest a more negative or dissatisfied genital self-image. This may reflect concerns or dissatisfaction with the appearance, function, or health of the genital area, which could be related to emotional or sexual concerns. * High Scores: Higher scores indicate a more positive or satisfied genital self-image, suggesting greater confidence or comfort with one's body in this regard.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

InMode MD Ltd.

Collaborator

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