Using radiofrequency to treat postpartum pain during intercourse
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum: Randomised Prospective Trial
This study is testing if a new treatment using radiofrequency therapy can help women who are 4 to 9 months postpartum with pain during intercourse feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Sex | Female |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05417334 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of resistive capacitive monopolar radiofrequency therapy combined with Thiele massage in treating de novo dyspareunia in women 4 to 9 months postpartum. Dyspareunia, or pain during vaginal penetration, can significantly impact a woman's quality of life and sexual wellbeing, particularly following childbirth. The study aims to assess whether radiofrequency can alleviate pain associated with this condition, which is often linked to obstetric injuries such as episiotomy or perineal tearing. The research is novel as there is limited evidence regarding the use of radiofrequency for this specific type of pain in postpartum women.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum women aged 4 to 9 months who are experiencing new onset dyspareunia following delivery.
Not a fit: Patients who had dyspareunia prior to labor, those with a history of vulvo-vaginal pathology, or those with contraindications to radiofrequency treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for postpartum women experiencing dyspareunia.
How similar studies have performed: While there is limited evidence specifically for postpartum dyspareunia, previous studies have shown potential benefits of radiofrequency in treating scar tissue, indicating a promising but untested approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 4-9 postpartum * de novo dyspareunia after delivery * obstetric injury * Grant informed consent Exclusion Criteria: * radiofrequency contraindications (pacemaker, active infection or pregnancy) * cesarean section * dyspareunia previous to labour * previous vulvo-vaginal pathology * patients with postpartum depression * patients with a pelvic region oncological history
Where this trial is running
Barcelona
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Carla E Box, PT, Msc
- Email: cebox@clinic.cat
- Phone: +34 699782115
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.