Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum.

Dyspareunia Clinical Trial

Official title:

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum: Randomised Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417334
• Other study ID #: HCB/2020/0484
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: Hospital Clinic of Barcelona
• Contact: Carla E Box, PT, Msc
• Phone: +34 699782115
• Email: cebox[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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