What is this study trying to find out about dyspareunia?

This study is investigating whether a treatment combining radiofrequency and ultrasound can reduce pain during sexual intercourse caused by scarring after vaginal delivery. The research focuses on women of childbearing age with postpartum dyspareunia. The goal is to provide evidence on this non-invasive therapy's impact on pain relief and quality of life.

Who may be eligible for this dyspareunia clinical trial?

Women aged 18 to 50 who have had at least one vaginal delivery and experience moderate to severe pain during penetrative sexual intercourse may be eligible. The study is for females with dyspareunia related to childbirth scarring and excludes those with medical conditions that prevent the use of the treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this dyspareunia clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, any personal travel expenses or other costs are not guaranteed to be covered and may vary. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 50Years

FEMALE

ID07504991

Evaluating BTL EXILIS Ultra 360 Device Combining Radiofrequency and Ultrasound to Treat Painful Intercourse Caused by Scarring After Vaginal Delivery in Women Aged 18 to 50

Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2026-04-16

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of combined monopolar radiofrequency and ultrasound technology BTL EXILIS Ultra 360 for treating dyspareunia, which is pain during sexual intercourse, caused by scarring after vaginal delivery. The study focuses on women of childbearing age who have experienced perineal trauma such as tears or episiotomies during childbirth. This non-randomized, quasi-experimental study aims to compare pain levels before and after treatment using a validated pain scale called the Visual Analogue Scale VAS.

CONDITIONS

Brief Title

Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia

Who Can Participate

Age: 18Years - 50Years

FEMALE

Eligibility Criteria

You may qualify if you...

Women of childbearing age
Medical history of at least one prior vaginal delivery
Persistent pain during penetrative sexual intercourse
Clinical diagnosis of dyspareunia
Moderate to severe pain level (VAS score of 4 or higher)
No restriction on time since last delivery

You will not qualify if you...

Medical conditions that prevent use of the study treatment
Dyspareunia not related to postpartum scarring

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 12 weeks

Participants receive up to three sessions of combined monopolar radiofrequency and ultrasound treatment using the BTL EXILIS Ultra 360™ device to reduce pain caused by postpartum scarring. After the first session, participants wait 4 to 6 weeks before the second session, followed by a pain assessment. If pain remains moderate to severe, a third session is offered, followed by a final assessment 4 to 6 weeks later.

2 to 3 treatment sessions and 2 to 3 follow-up assessments over 12 weeks

Research Team

LYS GARCIA VILAPLANA, Lead Researcher

CRISTINA REY REÑONES, DOCTORA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

Similar Trials

Comparing Womens Sexual Quality of Life After Benign Adnexal...

Gynecologic Disease

Actively Recruiting

1 location

Is Multimodal Physiotherapy andor Photobiomodulation Therapy...

Vulvodynia

Actively Recruiting

2 locations

Evaluating a New Hormone-Free Gel for Managing Menopause-Rel...

Vulvar Atrophy

Actively Recruiting

1 location

Comparing Womens Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES or Conventional Laparoscopy

Is Multimodal Physiotherapy andor Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia a Randomized Controlled Trial

Evaluating a New Hormone-Free Gel for Managing Menopause-Related Genitourinary Symptoms in Women Aged 40 to 70

Comparing Telerehabilitation and In-Person Physical Therapy to Improve Sexual Function and Reduce Pain in Menopausal Women with Dyspareunia

Evaluating BTL EXILIS Ultra 360 Device Combining Radiofrequency and Ultrasound to Treat Painful Intercourse Caused by Scarring After Vaginal Delivery in Women Aged 18 to 50

Study of Pre-Rehabilitation Pelvic Health Physical Therapy and Vaginal Dilator Education for Women Undergoing Pelvic Radiotherapy for Gynecological and Anal Cancers

Study of tDCS Stimulation to Improve Limb Function in Neurological Patients and Reduce Pain in Women with Gynaecological Conditions

Study Comparing a New Vibrating Pelvic Floor Device to Traditional Vaginal Dilators for Improving Sexual Function in Women with Genito-Pelvic Pain and Penetration Disorder

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

Published Research Related To This Trial

Randomized controlled clinical trial comparing guided bone regeneration of peri-implant defects with soft-type block versus particulate bone substitutes: Six-month results of hard-tissue changes.

Goran I Benic, Stefan P Bienz, Young Woo Song...

https://pubmed.ncbi.nlm.nih.gov/35191065/

Comments on management of the drug-seeking patient.

E C Covington

https://pubmed.ncbi.nlm.nih.gov/11327428/

Labial tissue rejuvenation and sexual function improvement using a novel noninvasive focused monopolar radio frequency device.

Zeljka Clark

https://pubmed.ncbi.nlm.nih.gov/28853967/

Dyspareunia in Women.

D Ashley Hill, Chantel A Taylor

https://pubmed.ncbi.nlm.nih.gov/33983001/

Absorbable suture materials for primary repair of episiotomy and second degree tears.

Christine Kettle, Therese Dowswell, Khaled Mk Ismail

https://pubmed.ncbi.nlm.nih.gov/20556745/

The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis.

Melle A Spruijt, Wenche M Klerkx, Johannes C Kelder...

https://pubmed.ncbi.nlm.nih.gov/35362767/

Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy.

Yuki Sekiguchi, Yukari Utsugisawa, Yoko Azekosi...

https://pubmed.ncbi.nlm.nih.gov/23952177/

Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies.

Yona Tadir, Adrian Gaspar, Ahinoam Lev-Sagie...

https://pubmed.ncbi.nlm.nih.gov/28220946/

Efficacy and Safety of Laser Therapy for the Treatment of Genitourinary Syndrome of Menopause: A Protocol for Systematic Review and Meta-Analysis of Clinical Trials.

Lisieux de Lourdes Martins Nóbrega Pessoa, Ayane Cristine Alves Sarmento, Kleyton Santos Medeiros...

https://pubmed.ncbi.nlm.nih.gov/36304041/

Obstetric Lacerations: Prevention and Repair.

Michael J Arnold, Kerry Sadler, KelliAnn Leli

https://pubmed.ncbi.nlm.nih.gov/34128615/

Evaluating BTL EXILIS Ultra 360 Device Combining Radiofrequency and Ultrasound to Treat Painful Intercourse Caused by Scarring After Vaginal Delivery in Women Aged 18 to 50

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Comparing Womens Sexual Quality of Life After Benign Adnexal...

Is Multimodal Physiotherapy andor Photobiomodulation Therapy...

Evaluating a New Hormone-Free Gel for Managing Menopause-Rel...

Frequently Asked Questions

What is this study trying to find out about dyspareunia?

Who may be eligible for this dyspareunia clinical trial?

Is there any cost to participate in this dyspareunia clinical trial?

Will I receive the BTL EXILIS treatment or a placebo?

How will the study measure changes in pain during sexual intercourse?

What happens after this dyspareunia clinical trial ends?

Can I leave this dyspareunia clinical trial if I change my mind?

Not the Right Trial for You?

Published Research Related To This Trial

Randomized controlled clinical trial comparing guided bone regeneration of peri-implant defects with soft-type block versus particulate bone substitutes: Six-month results of hard-tissue changes.

Comments on management of the drug-seeking patient.

Labial tissue rejuvenation and sexual function improvement using a novel noninvasive focused monopolar radio frequency device.

Dyspareunia in Women.

Absorbable suture materials for primary repair of episiotomy and second degree tears.

The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis.

Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy.

Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies.

Efficacy and Safety of Laser Therapy for the Treatment of Genitourinary Syndrome of Menopause: A Protocol for Systematic Review and Meta-Analysis of Clinical Trials.

Obstetric Lacerations: Prevention and Repair.

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Comparing Womens Sexual Quality of Life After Benign Adnexal...

Is Multimodal Physiotherapy andor Photobiomodulation Therapy...

Evaluating a New Hormone-Free Gel for Managing Menopause-Rel...

Frequently Asked Questions

What is this study trying to find out about dyspareunia?

Who may be eligible for this dyspareunia clinical trial?

Is there any cost to participate in this dyspareunia clinical trial?

Will I receive the BTL EXILIS treatment or a placebo?

How will the study measure changes in pain during sexual intercourse?

What happens after this dyspareunia clinical trial ends?

Can I leave this dyspareunia clinical trial if I change my mind?

Published Research Related To This Trial

Randomized controlled clinical trial comparing guided bone regeneration of peri-implant defects with soft-type block versus particulate bone substitutes: Six-month results of hard-tissue changes.

Comments on management of the drug-seeking patient.

Labial tissue rejuvenation and sexual function improvement using a novel noninvasive focused monopolar radio frequency device.

Dyspareunia in Women.

Absorbable suture materials for primary repair of episiotomy and second degree tears.

The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis.

Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy.

Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies.

Efficacy and Safety of Laser Therapy for the Treatment of Genitourinary Syndrome of Menopause: A Protocol for Systematic Review and Meta-Analysis of Clinical Trials.

Obstetric Lacerations: Prevention and Repair.

Sponsors