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

NCT05417334 | Recruiting

• 1 other identifier: HCB/2020/0484
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia

Keywords

dyspareunia; radiofrequency; postpartum pain; perineal massage; episiotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of the baseline Sexual function and after 5 sessions

  Baseline and after 7 weeks

• Change of the baseline muscle pain points and after 5 sessions

  Baseline and after 7 weeks

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

  Baseline and after 7 weeks

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

  Baseline and after 7 weeks

Study Arms (2)

ON Radiofrequency treatment

ACTIVE COMPARATOR

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

Sham Radiofrequency treatment

SHAM COMPARATOR

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

Interventions

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

ON Radiofrequency treatment; Sham Radiofrequency treatment

Eligibility Criteria

• Gender Eligibility Details: postpartum women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• postpartum
• de novo dyspareunia after delivery
• obstetric injury
• Grant informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Carla E Box, PT, Msc

CONTACT

+34 699782115; cebox@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: March 18, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)