Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT07504991

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

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

34

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objective of this community-based, non-randomized, quasi-experimental study is to assess the effectiveness of BTL EXILIS technology-based on combined radiofrequency and ultrasound-in women of childbearing age from an industrialized country with a diagnosis of dyspareunia following vaginal delivery. The primary research question is: \- Do patients experience a resolution of pain during sexual intercourse after completing the treatment? The researcher will compare the level of pain during intercourse-following at least one vaginal delivery involving a tear or episiotomy-before and after exposure to the BTL Exilis treatment in the same individual. Participants: * Assessment following childbirth with perineal involvement (tear or episiotomy) and presenting with dyspareunia. * Verification of fulfillment of inclusion criteria. * Decision on whether to undergo treatment, following a briefing by the researcher on the process and the signing of the informed consent form for study participation. * Follow-up assessment one and a half months after completing the treatment.

CONDITIONS

Official 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
  • History of at least one vaginal delivery
  • Persistent pain during penetrative sexual intercourse
  • Clinical diagnosis of dyspareunia
  • Moderate to severe pain with a VAS score of 4 or higher
  • No limit 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

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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

CONTACT

C

CRISTINA REY REÑONES, DOCTORA

CONTACT

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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