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

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Dyspareunia

Treatments: Device: Resistive Capicitive Monopolar Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT05417334

HCB/2020/0484

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

ON Radiofrequency treatment

Active Comparator group

Description:

Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week.

Treatment:

Device: Resistive Capicitive Monopolar Radiofrequency

Sham Radiofrequency treatment

Sham Comparator group

Description:

Application of the technique in the intervention group (inactive resistive capacitive monopolar radiofrequency therapy): the intervention group will receive treatment with inactive RF, with the electrode at a medium intensity for 20 minutes per session during a total of 5 sessions, the 3 first ones held weekly and the 2 last ones every other week.

Treatment:

Device: Resistive Capicitive Monopolar Radiofrequency