Actively Recruiting
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum: Randomised Prospective Trial
Led by Hospital Clinic of Barcelona · Updated on 2025-12-09
110
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of resistive capacitive monopolar radiofrequency therapy combined with Thiele massage on treating new onset dyspareunia, a type of pain during vaginal penetration, in women 4 to 9 months after giving birth. This condition can affect quality of life and sexual wellbeing, especially following childbirth injuries like episiotomy, tearing, or difficult labor. The study aims to evaluate whether radiofrequency therapy can help reduce pain associated with this postpartum condition. Participants will be randomly assigned to one of two groups: one receiving active radiofrequency therapy and the other a sham (inactive) treatment. Both groups will undergo five 20-minute sessions; the first three sessions will be weekly, and the last two every other week. The therapy targets the abdominal area, vulva, and pelvic floor, and participants also perform daily Thiele massage at home. Throughout the study, researchers will assess changes in pain levels during penetration, sexual function, muscle pain points, pelvic floor dysfunction, and quality of life at the start and after seven weeks. Participants will be monitored during the treatment period to evaluate these outcomes and the overall impact of the therapy. The study is double-blinded and randomized, ensuring objective results over the planned treatment sessions.
CONDITIONS
Brief Title
Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 4 to 9 months postpartum
- New onset dyspareunia after delivery
- History of obstetric injury
- Able to give informed consent
You will not qualify if you...
- Contraindications to radiofrequency therapy such as pacemaker, active infection, or pregnancy
- Having had a cesarean section
- Dyspareunia before labor
- Previous vulvo-vaginal pathologies
- Postpartum depression
- History of pelvic region cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks
Participants receive 5 radiofrequency therapy sessions including treatment of the abdominal region, vulva, pelvic floor tissue, and perform Thiele massage daily at home.
5 treatment sessions: first 3 weekly, last 2 every other week
Trial Site Locations
Total: 1 location
1
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
Research Team
C
Carla E Box, PT, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here