Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
Recruiting now · Not applicable
Conditions studied: Dyspareunia
In brief
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.
Key facts
- Study ID
- NCT07504991
- Run by
- Institut Investigacio Sanitaria Pere Virgili
- People needed
- 34
- Starts
- 2026-04-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women of childbearing age
- Medical history of at least one prior vaginal delivery
- Reported persistent pain during penetrative sexual intercourse
- Meeting the clinical criteria for dyspareunia
- Moderate to severe pain level, defined as a score of 4 or higher on the Visual Analogue Scale (VAS 0-10)
- Eligible patients must demonstrate a moderate to severe pain level, defined as a VAS score of 4 or higher
- No restriction on the time elapsed between the last delivery and the current clinical diagnosis.
You may not qualify if…
- Contraindications to the study treatment. Women with any medical condition that precludes the use of the study technology
- Non-postpartum dyspareunia
Where it is running
- Centro Procrear — Tarragona, TARRAGONA, Spain (enrolling)
Full record on ClinicalTrials.gov
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