NCT05417334

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum.

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum: Randomised Prospective Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 9 months postpartum.

Detailed description

Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum. There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP. The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 9 months.

Conditions

• Dyspareunia

Interventions

Type	Name	Description
DEVICE	Resistive Capicitive Monopolar Radiofrequency	5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home

Timeline

• Start date: 2021-03-18
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2022-06-14
• Last updated: 2025-12-09

Locations

1 site across 1 country: Spain