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

RecruitingNAAges 18 Years - 50 YearsFemaleInstitut Investigacio Sanitaria Pere Virgili
NCT07504991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Contraindications to the study treatment. Women with any medical condition that precludes the use of the study technology * Non-postpartum dyspareunia
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What it tests

  • Combining radiofrequency and ultrasound. BTL Exilis
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Where

1 site
Centro Procrear
Tarragona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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