Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID07504991

Effectiveness of Combined Monopolar Radiofrequency and Ultrasound (BTL EXILIS ULTRA 360) for Improving Dyspareunia Caused by Postpartum Scarring in Women of Childbearing Age

Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2026-04-16

34

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of combined monopolar radiofrequency and ultrasound technology (BTL EXILIS Ultra 360) for treating dyspareunia, which is pain during sexual intercourse, caused by scarring after vaginal delivery. The study focuses on women of childbearing age who have experienced perineal trauma such as tears or episiotomies during childbirth. This non-randomized, quasi-experimental study aims to compare pain levels before and after treatment using a validated pain scale called the Visual Analogue Scale (VAS).

CONDITIONS

Brief Title

Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women of childbearing age
  • Medical history of at least one prior vaginal delivery
  • Persistent pain during penetrative sexual intercourse
  • Clinical diagnosis of dyspareunia
  • Moderate to severe pain level (VAS score of 4 or higher)
  • No restriction on time since last delivery
Not Eligible

You will not qualify if you...

  • Medical conditions that prevent use of the study treatment
  • Dyspareunia not related to postpartum scarring

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 12 weeks

Participants receive up to three sessions of combined monopolar radiofrequency and ultrasound treatment using the BTL EXILIS Ultra 360™ device to reduce pain caused by postpartum scarring. After the first session, participants wait 4 to 6 weeks before the second session, followed by a pain assessment. If pain remains moderate to severe, a third session is offered, followed by a final assessment 4 to 6 weeks later.

2 to 3 treatment sessions and 2 to 3 follow-up assessments over 12 weeks

Trial Site Locations

Total: 1 location

1

Centro Procrear

Tarragona, TARRAGONA, Spain, 43002

Actively Recruiting

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Research Team

L

LYS GARCIA VILAPLANA, Lead Researcher

C

CRISTINA REY REÑONES, DOCTORA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device.

Monique J Vanaman Wilson, Joanna Bolton, Isabela T Jones...

https://pubmed.ncbi.nlm.nih.gov/29701623

Efficacy and Safety of Laser Therapy for the Treatment of Genitourinary Syndrome of Menopause: A Protocol for Systematic Review and Meta-Analysis of Clinical Trials.

Lisieux de Lourdes Martins Nóbrega Pessoa, Ayane Cristine Alves Sarmento, Kleyton Santos Medeiros...

https://pubmed.ncbi.nlm.nih.gov/36304041

The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis.

Melle A Spruijt, Wenche M Klerkx, Johannes C Kelder...

https://pubmed.ncbi.nlm.nih.gov/35362767

Randomized controlled clinical trial comparing guided bone regeneration of peri-implant defects with soft-type block versus particulate bone substitutes: Six-month results of hard-tissue changes.

Goran I Benic, Stefan P Bienz, Young Woo Song...

https://pubmed.ncbi.nlm.nih.gov/35191065

[Effectiveness of multimodal rehabilitation (biofeedback plus capacitive-resistive radiofrequency) on chronic pelvic pain and dyspareunia: prospective study and literature review].

M E Fernández-Cuadros, S G Kazlauskas, M J Albaladejo-Florin...

https://pubmed.ncbi.nlm.nih.gov/32441260