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

NCT06872281 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: COA.No. MURA2025/130
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fractional bipolar radiofrequency therapy

Outcome Measures

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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (6)

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

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

• Subjective outcome: Patient-reported adverse events

  From post-treatment to the end of the 12-week treatment period

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

  From enrollment to the end of treatment at 12 weeks

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

  From enrollment to the end of treatment at 12 weeks

• Subjective outcome: The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Intervention (fractional bipolar radiofrequency therapy)

ACTIVE COMPARATOR

A single treatment with intravaginal device for fractional bipolar radiofrequency therapy. Using the EmpowerRF platform with the Morpheus8V applicator, RF energy was applied via 24 microneedles, to release the radiofrequency energy to the vaginal mucosa

Device: Fractional bipolar radiofrequency

Sham group

SHAM COMPARATOR

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.

Device: Sham device

Interventions

Fractional bipolar radiofrequency DEVICE

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

Intervention (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.

Sham group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Willing to undergo vaginal energy-based treatment and attend follow-up visits 3 months after treatment

You may not qualify if:

• \- 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
• Currently using intrauterine devices for contraception
• Presence of any active electrical implant such as pacemaker, internal defibrillator
• Current condition of genital cancer

Sponsors & Collaborators

• Mahidol University: lead
• InMode MD Ltd.: collaborator

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (6)

• Abdelaziz A, Blusewicz TA, Coley KP, Karram M. Safety, tolerability and short-term efficacy of transvaginal fractional bipolar radiofrequency therapy for symptoms of stress and or mixed incontinence in conjunction with genitourinary syndrome of menopause. Neurourol Urodyn. 2023 Apr;42(4):807-813. doi: 10.1002/nau.25170. Epub 2023 Mar 4.

  PMID: 36870045 RESULT

• Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010 Sep;7(9):3088-95. doi: 10.1111/j.1743-6109.2010.01910.x.

  PMID: 20584127 RESULT

• Wattanakrai P, Limpjaroenviriyakul N, Thongtan D, Wattanayingcharoenchai R, Manonai J. The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial. Lasers Med Sci. 2022 Apr;37(3):1829-1842. doi: 10.1007/s10103-021-03438-3. Epub 2021 Oct 14.

  PMID: 34647191 RESULT

• Polland A, Duong V, Furuya R, Fitzgerald JJ, Wang H, Iwamoto A, Bradley S, Iglesia CB. Description of Vaginal Laxity and Prolapse and Correlation With Sexual Function (DeVeLoPS). Sex Med. 2021 Dec;9(6):100443. doi: 10.1016/j.esxm.2021.100443. Epub 2021 Oct 8.

  PMID: 34629323 RESULT

• Dayan E. Noninvasive Vulvar and Intravaginal Treatments. Clin Plast Surg. 2022 Oct;49(4):505-508. doi: 10.1016/j.cps.2022.07.004.

  PMID: 36162945 RESULT

• Krychman ML. Vaginal Laxity Issues, Answers and Implications for Female Sexual Function. J Sex Med. 2016 Oct;13(10):1445-7. doi: 10.1016/j.jsxm.2016.07.016. Epub 2016 Aug 23. No abstract available.

  PMID: 27567072 RESULT

Study Officials

• Suthanud Premchit, MD

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthanud Premchit, MD

CONTACT

(66)+954575848; dai_suthanud@hotmail.com

Orawee Chinthakanan, Assoc.Prof.

CONTACT

(66)+19522215; orawee.chi@mahidol.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study employs a double-blind design to minimize bias by blinding both the patients and evaluators. All patients, regardless of group, will remain blinded. 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. The physician managing the allocation, will not be involved in the treatment procedures or the assessment process. Subjective outcomes, such as questionnaires (VLQ, FSFI, FGSIS, ICIG-VS, PGI-I), will be assessed by a research assistant from the urogynecology clinic who is blinded to the group assignments, ensuring she is unaware of which patients received the actual treatment and which received the sham.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment was performed using the Empower RF Morpheus8V device (InMode), * Insert device into vaginal * Do not need for anesthesia * Applying fractional bipolar RF energy in a stamping method * 50% overlap along the entire length of the vagina to the introitus, At intervals of 9, 10:30, 12, 1:30, 3, 4:30, 6, and 7:30. * Two passes were made at depths of 1, 2, and 3 mm.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 12, 2025
• Study Start: April 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)