Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia (NCT07504991) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
Spain34 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain Intensity During Sexual Intercourse
Timeframe: Baseline, and at the end of the 1st, 2nd, and 3rd treatment sessions (approximately 12 weeks)
Trial details
NCT IDNCT07504991
SponsorInstitut Investigacio Sanitaria Pere Virgili