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

NCT07504991 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-16

No results posted yet for this study

Summary

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

  • Dyspareunia

Interventions

DEVICE

Combining radiofrequency and ultrasound. BTL Exilis

Following the first session, participants will wait 4-6 weeks before undergoing the second session. Four to six weeks after the second session, a new medical history (anamnesis) will be taken to re-evaluate and quantify the perceived pain during intercourse using the Visual Analogue Scale (VAS). If the score is equal to or greater than 4, an immediate third session will be offered. Four to six weeks after the third session of BTL EXILIS Ultra 360º (Ultrafemme version), if required, pain during intercourse will be assessed once more for a third quantification; this figure will be recorded as the final VAS score following the treatment.

Sponsors & Collaborators

  • Institut Investigacio Sanitaria Pere Virgili

    lead OTHER

Principal Investigators

  • LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT · UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-07-01
Completion
2026-12-31
FDA Device
Yes

Countries

  • Spain

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 NCT07504991 on ClinicalTrials.gov