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.
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
Contraindications to the study treatment. Women with any medical condition that precludes the use of the study technology
Non-postpartum dyspareunia
Single group
Combining radiofrequency and ultrasound. BTL Exilis
DeviceFollowing 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.
Change in pain Intensity During Sexual Intercourse
Pain intensity measured using the Visual Analogue Scale (VAS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable". A higher score represents greater pain intensity
Obstetric History: Parity
Total number of previous deliveries (parity) to evaluate its correlation with baseline dyspareunia severity
Time Since Last Delivery
Number of months elapsed from the last childbirth to the diagnosis of dyspareunia
History of Prior Deliveries (Years)
Recording the specific years of the first, second, and third deliveries to establish the patient's reproductive timeline
Presence of Perineal Scarring
Assessment of the presence or absence of perineal scars (categorical: Yes/No) resulting from previous deliveries (e.g., episiotomy or tears)
Click on the lead sponsor to view all of their trials.
