Clinical Trial

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

Recruiting
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Record status
This record was last updated April 16, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-03-26; most recent amendment 2026-04-13.
Trial Details
NCT Number NCT07504991
Lead Sponsor Institut Investigacio Sanitaria Pere Virgili
Conditions Dyspareunia
Enrollment 34 participants
Start Date 2026-04
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-16