Radiofrequency combined with ultrasound for postpartum sexual pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.