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Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
Sponsor: Institut Investigacio Sanitaria Pere Virgili
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.
Official title: Effectiveness of Combined Monopolar Radiofrequency and Ultrasound (BTL EXILIS ULTRA 360™) for the Improvement of Dyspareunia Caused by Postpartum Scarring in Women of Childbearing Age: A Study Protoco
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-02
Completion Date
2026-12
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Centro Procrear
Tarragona, TARRAGONA, Spain