Clinical trial · Interventional
Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
RF-Vaginale : Randomised Phase III Trial Evaluating the Efficacy and Safety of Vaginal Radiofrequency in the Management of Vulvovaginal Atrophy and Dryness in Patients Treated for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer. Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment: The first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators. The second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Vaginal Dryness | — | UNRESOLVED | — |
| Vulvovaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GynWave-360 | Device | — | UNRESOLVED |
| Local hydratation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaginal radiofrequency treatment
- description
- The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultationsup to 6 months, M0, M3 and M6). The blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for patients in the control group who are not sufficiently relieved.
- interventionNames
- Device: GynWave-360
- Other: Local hydratation
- type
- ACTIVE_COMPARATOR
- label
- Reference treatment
- description
- Local hydration: hyaluronic acid-based treatment, 3 applications per week Possibility of resorting to associated measures chosen by the investigator (physical therapy, vaginal dilators, etc.), excluding physical treatments (vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection, or lipomodelling).
- interventionNames
- Other: Local hydratation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
INCLUSION CRITERIA : * Patient over 40 years * Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3 * Patient undergoing adjuvant treatment for breast cancer * Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months * Patient affiliated to a social security organization * Patient having signed the informed consent for the present study EXCLUSION CRITERIA: * Contraindications related to the radiofrequency technique: * Ongoing urinary tract infection * Pacemaker * IUD intrauterine device * Pregnancy * Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc. * Neurodegenerative disease with perineal involvement * Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling. * Pregnant or breast-feeding women * Patients under guardianship or trusteeship.
References
Publications (53)
- BACKGROUNDFaubion SS, Sood R, Kapoor E. Genitourinary Syndrome of Menopause: Management Strategies for the Clinician. Mayo Clin Proc. 2017 Dec;92(12):1842-1849. doi: 10.1016/j.mayocp.2017.08.019. PMID 29202940
- BACKGROUNDPortman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329. PMID 25160739
- BACKGROUNDMoral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7. PMID 29411644
- BACKGROUNDSimon JA, Davis SR, Althof SE, Chedraui P, Clayton AH, Kingsberg SA, Nappi RE, Parish SJ, Wolfman W. Sexual well-being after menopause: An International Menopause Society White Paper. Climacteric. 2018 Oct;21(5):415-427. doi: 10.1080/13697137.2018.1482647. Epub 2018 Jul 10. PMID 29987939
- BACKGROUNDNappi RE, Cucinella L, Martella S, Rossi M, Tiranini L, Martini E. Female sexual dysfunction (FSD): Prevalence and impact on quality of life (QoL). Maturitas. 2016 Dec;94:87-91. doi: 10.1016/j.maturitas.2016.09.013. Epub 2016 Sep 28. PMID 27823751
- BACKGROUNDKaur N, Gupta A, Sharma AK, Jain A. Survivorship issues as determinants of quality of life after breast cancer treatment: Report from a limited resource setting. Breast. 2018 Oct;41:120-126. doi: 10.1016/j.breast.2018.07.003. Epub 2018 Jul 11. PMID 30029054
- BACKGROUNDOyarzun MFG, Castelo-Branco C. Local hormone therapy for genitourinary syndrome of menopause in breast cancer patients: is it safe? Gynecol Endocrinol. 2017 Jun;33(6):418-420. doi: 10.1080/09513590.2017.1290076. Epub 2017 Feb 21.