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

Primary Purpose

Dyspareunia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Resistive Capicitive Monopolar Radiofrequency
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring dyspareunia, radiofrequency, postpartum pain, perineal massage, episiotomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Clinic BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ON Radiofrequency treatment

Sham Radiofrequency treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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).
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)

Full Information

First Posted
June 2, 2022
Last Updated
June 9, 2022
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05417334
Brief Title
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum.
Official Title
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum: Randomised Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia
Keywords
dyspareunia, radiofrequency, postpartum pain, perineal massage, episiotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ON Radiofrequency treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham Radiofrequency treatment
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Resistive Capicitive Monopolar Radiofrequency
Intervention Description
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Primary Outcome Measure Information:
Title
Change of the baseline Level of pain during penetration and after 5 sessions
Description
Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all.
Time Frame
Baseline and after 7 weeks
Secondary Outcome Measure Information:
Title
Change of the baseline Sexual function and after 5 sessions
Description
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).
Time Frame
Baseline and after 7 weeks
Title
Change of the baseline muscle pain points and after 5 sessions
Description
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.
Time Frame
Baseline and after 7 weeks
Title
Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions
Description
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).
Time Frame
Baseline and after 7 weeks
Title
Change of the baseline affection on the quality of life and after 5 sessions
Description
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)
Time Frame
Baseline and after 7 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
postpartum women
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla E Box, PT, Msc
Phone
+34 699782115
Email
cebox@clinic.cat
Facility Information:
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla E Box, PT, Msc
Phone
+34699782115
Email
cebox@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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