Radiofrequency combined with ultrasound for postpartum sexual pain
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
This study will try a combined radiofrequency and ultrasound treatment (BTL Exilis) to reduce pain during sex in women who developed dyspareunia after a vaginal delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili Academic / other |
| Locations | 1 site (Tarragona, TARRAGONA) |
| Trial ID | NCT07504991 on ClinicalTrials.gov |
What this trial studies
This is a community-based, non-randomized, quasi-experimental study delivering monopolar radiofrequency combined with ultrasound (BTL Exilis) to women with dyspareunia following at least one vaginal delivery that involved a tear or episiotomy. Pain during penetrative intercourse will be measured before and after treatment in the same individuals using the Visual Analogue Scale (VAS), with moderate-to-severe pain defined as VAS ≥4. There is no randomized control group; the primary outcome is resolution or reduction of pain during sexual intercourse after completing the treatment. The trial is conducted at Centro Procrear in Tarragona and requires informed consent and clinical confirmation of postpartum dyspareunia.
Who should consider this trial
Good fit: Women of childbearing age with at least one prior vaginal delivery involving a tear or episiotomy, persistent moderate-to-severe dyspareunia (VAS ≥4), and no contraindications to radiofrequency/ultrasound are ideal candidates.
Not a fit: Patients with non-postpartum causes of dyspareunia, mild pain (VAS <4), underlying pelvic pathology causing pain, or medical contraindications to the device are unlikely to benefit.
Why it matters
Potential benefit: If successful, the treatment could reduce or eliminate pain during intercourse and improve sexual function and quality of life for affected women.
How similar studies have performed: Energy-based vaginal therapies including radiofrequency have been used for vaginal laxity and sexual symptoms with mixed and limited high-quality evidence, and specific data for postpartum dyspareunia are sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tarragona, TARRAGONA
- Centro Procrear — Tarragona, Tarragona, Spain (Recruiting)
Study contacts
- Principal investigator: Lys Garcia Vilaplana, Midwife. Phd Student — Universitat Rovira I Virgili. Procrear Medical Center
- Study coordinator: LYS GARCIA VILAPLANA, Lead Researcher
- Email: lys@procrear.es
- Phone: +34619357158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.