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

NCT07504991 | Recruiting DMC FDA Device

• 1 other identifier: 029/2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this community-based, non-randomized, quasi-experimental study is to assess the effectiveness of BTL EXILIS technology-based on combined radiofrequency and ultrasound-in women of childbearing age from an industrialized country with a diagnosis of dyspareunia following vaginal delivery. The primary research question is: \- Do patients experience a resolution of pain during sexual intercourse after completing the treatment? The researcher will compare the level of pain during intercourse-following at least one vaginal delivery involving a tear or episiotomy-before and after exposure to the BTL Exilis treatment in the same individual. Participants:

• Assessment following childbirth with perineal involvement (tear or episiotomy) and presenting with dyspareunia.
• Verification of fulfillment of inclusion criteria.
• Decision on whether to undergo treatment, following a briefing by the researcher on the process and the signing of the informed consent form for study participation.
• Follow-up assessment one and a half months after completing the treatment.

Conditions

Dyspareunia

Keywords

vaginal delivery; dyspareunia; radiofrequency; perineum; Visual Analogue Scale; tear scar; episiotomy scar; woman; pain

Outcome Measures

Primary Outcomes (1)

• Change in pain Intensity During Sexual Intercourse

  Pain intensity measured using the Visual Analogue Scale (VAS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable". A higher score represents greater pain intensity

  Baseline, and at the end of the 1st, 2nd, and 3rd treatment sessions (approximately 12 weeks)

Secondary Outcomes (5)

• Obstetric History: Parity

  Baseline (Day 1)

• Time Since Last Delivery

  Baseline (Day 1)

• History of Prior Deliveries (Years)

  Baseline (Day 1)

• Presence of Perineal Scarring

  Baseline (Day 1)

• Patient Age

  Baseline (Day 1)

Study Arms (1)

Women with dyspareunia

EXPERIMENTAL

Participants who meet the inclusion criteria at the time of evaluation and who consent to the use of BTL Exilis technology.

Device: Combining radiofrequency and ultrasound. BTL Exilis

Interventions

Combining radiofrequency and ultrasound. BTL Exilis DEVICE

Following the first session, participants will wait 4-6 weeks before undergoing the second session. Four to six weeks after the second session, a new medical history (anamnesis) will be taken to re-evaluate and quantify the perceived pain during intercourse using the Visual Analogue Scale (VAS). If the score is equal to or greater than 4, an immediate third session will be offered. Four to six weeks after the third session of BTL EXILIS Ultra 360º (Ultrafemme version), if required, pain during intercourse will be assessed once more for a third quantification; this figure will be recorded as the final VAS score following the treatment.

Women with dyspareunia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of childbearing age
• Medical history of at least one prior vaginal delivery
• Reported persistent pain during penetrative sexual intercourse
• Meeting the clinical criteria for dyspareunia
• Moderate to severe pain level, defined as a score of 4 or higher on the Visual Analogue Scale (VAS 0-10)
• Eligible patients must demonstrate a moderate to severe pain level, defined as a VAS score of 4 or higher
• No restriction on the time elapsed between the last delivery and the current clinical diagnosis.

You may not qualify if:

• Contraindications to the study treatment. Women with any medical condition that precludes the use of the study technology
• Non-postpartum dyspareunia

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Centro Procrear

Tarragona, TARRAGONA, 43002, Spain

RECRUITING

Related Publications (14)

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  PMID: 28853967 BACKGROUND

• Vanaman Wilson MJ, Bolton J, Jones IT, Wu DC, Calame A, Goldman MP. Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device. Dermatol Surg. 2018 May;44(5):705-713. doi: 10.1097/DSS.0000000000001453.

  PMID: 29701623 BACKGROUND

• Dunbar SW, Goldberg DJ. Radiofrequency in Cosmetic Dermatology: An Update. J Drugs Dermatol. 2015 Nov;14(11):1229-38.

  PMID: 26580871 BACKGROUND

• Tadir Y, Gaspar A, Lev-Sagie A, Alexiades M, Alinsod R, Bader A, Calligaro A, Elias JA, Gambaciani M, Gaviria JE, Iglesia CB, Selih-Martinec K, Mwesigwa PL, Ogrinc UB, Salvatore S, Scollo P, Zerbinati N, Nelson JS. Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies. Lasers Surg Med. 2017 Feb;49(2):137-159. doi: 10.1002/lsm.22637. Epub 2017 Feb 21.

  PMID: 28220946 BACKGROUND

• Pessoa LLMN, Sarmento ACA, Medeiros KS, Costa APF, Goncalves AK, Cobucci RN. 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. Front Reprod Health. 2021 Oct 26;3:772690. doi: 10.3389/frph.2021.772690. eCollection 2021.

  PMID: 36304041 BACKGROUND

• Spruijt MA, Klerkx WM, Kelder JC, Kluivers KB, Kerkhof MH. The efficacy of botulinum toxin a injections in pelvic floor muscles in chronic pelvic pain patients: a systematic review and meta-analysis. Int Urogynecol J. 2022 Nov;33(11):2951-2961. doi: 10.1007/s00192-022-05115-7. Epub 2022 Apr 1.

  PMID: 35362767 BACKGROUND

• Benic GI, Bienz SP, Song YW, Cha JK, Hammerle CHF, Jung UW, Jung RE. 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. J Clin Periodontol. 2022 May;49(5):480-495. doi: 10.1111/jcpe.13606. Epub 2022 Mar 8.

  PMID: 35191065 BACKGROUND

• Fernandez-Cuadros ME, Kazlauskas SG, Albaladejo-Florin MJ, Robles-Lopez M, Laborda-Delgado A, de la Cal-Alvarez C, Perez-Moro O. [Effectiveness of multimodal rehabilitation (biofeedback plus capacitive-resistive radiofrequency) on chronic pelvic pain and dyspareunia: prospective study and literature review]. Rehabilitacion (Madr). 2020 Jul-Sep;54(3):154-161. doi: 10.1016/j.rh.2020.02.005. Epub 2020 May 6. Spanish.

  PMID: 32441260 BACKGROUND

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  PMID: 11327428 BACKGROUND

• Hill DA, Taylor CA. Dyspareunia in Women. Am Fam Physician. 2021 May 15;103(10):597-604.

  PMID: 33983001 BACKGROUND

• Lalji S, Lozanova P. Evaluation of the safety and efficacy of a monopolar nonablative radiofrequency device for the improvement of vulvo-vaginal laxity and urinary incontinence. J Cosmet Dermatol. 2017 Jun;16(2):230-234. doi: 10.1111/jocd.12348. Epub 2017 May 29.

  PMID: 28556393 BACKGROUND

• Sekiguchi Y, Utsugisawa Y, Azekosi Y, Kinjo M, Song M, Kubota Y, Kingsberg SA, Krychman ML. Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt). 2013 Sep;22(9):775-81. doi: 10.1089/jwh.2012.4123. Epub 2013 Aug 16.

  PMID: 23952177 BACKGROUND

• Kettle C, Dowswell T, Ismail KM. Absorbable suture materials for primary repair of episiotomy and second degree tears. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD000006. doi: 10.1002/14651858.CD000006.pub2.

  PMID: 20556745 BACKGROUND

• Arnold MJ, Sadler K, Leli K. Obstetric Lacerations: Prevention and Repair. Am Fam Physician. 2021 Jun 15;103(12):745-752.

  PMID: 34128615 BACKGROUND

MeSH Terms

Conditions

Dyspareunia; Pain

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT

  UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LYS GARCIA VILAPLANA, Lead Researcher

CONTACT

+34619357158; lys@procrear.es

CRISTINA REY REÑONES, DOCTORA

CONTACT

+34686853715; cristina.rey@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MIDWIFE

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)