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Completed

NCT Number: NCT05417334

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 12 Months Postpartum.

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 12 months postpartum.

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Key information

Conditions

Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

About this study

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 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4-12 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
  • patients with a history of pelvic trauma

Treatment and study plan

Resistive Capicitive Monopolar Radiofrequency

Device

5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home

Primary outcomes

  1. Change of the baseline Level of pain during penetration and after 5 sessions

    Time frame: Baseline and after 7 weeks

    Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all.

Secondary outcomes

  1. Change of the baseline Sexual function and after 5 sessions

    Time frame: Baseline and after 7 weeks

    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).

  2. Change of the baseline muscle pain points and after 5 sessions

    Time frame: Baseline and after 7 weeks

    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.

  3. Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions

    Time frame: Baseline and after 7 weeks

    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).

  4. Change of the baseline affection on the quality of life and after 5 sessions

    Time frame: Baseline and after 7 weeks

    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)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 12 Months Postpartum: Randomised Prospective Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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