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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspareunia
• Intervention / Treatment: Device: Resistive Capicitive Monopolar Radiofrequency

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla E Box, PT, Msc; Phone Number: +34 699782115; Email: cebox@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic Barcelona
    • Contact: Carla E Box, PT, Msc; Phone Number: +34699782115; Email: cebox@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ON Radiofrequency treatment; 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.	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
Sham Comparator: Sham Radiofrequency treatment; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the baseline Level of pain during penetration and after 5 sessions	Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all.	Baseline and after 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the baseline Sexual function and after 5 sessions	Using the Female Sexual Function Index (FSFI), where higher scores indicate higher degrees of sexual functioning of a total of 36 points (and lower pain).	Baseline and after 7 weeks
Change of the baseline muscle pain points and after 5 sessions	A physical evaluation held by the physical therapist seeking for pain points and asking the patient to score the amount of pain using the visual analogue scale (VAS) where 10 is the highest level of pain possible and 0 is no pain at all.	Baseline and after 7 weeks
Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions	Using the Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), in which the higher the score the greater the perceived impact that the pelvic floor dysfunction has on the patient's life (range 0 to 300 points).	Baseline and after 7 weeks
Change of the baseline affection on the quality of life and after 5 sessions	Using the EuroQuality of life-5D (EQ5D),where the maximum score of 1 indicates the best health state and therefore, higher scores indicate more severe or frequent problems (range from 0 to 10)	Baseline and after 7 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dyspareunia; episiotomy; radiofrequency; perineal massage; postpartum pain
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Dyspareunia
• Other Study ID Numbers: HCB/2020/0484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No