Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
NCT ID: NCT06503003
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-09-01
2025-01-01
Brief Summary
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Does non-ablative dual-wavelength diode laser therapy improve vaginal dryness, burning sensation, and dyspareunia in post-menopausal women? What is the impact of this therapy on the vaginal health index and sexual function? Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM.
Participants will:
Undergo three monthly sessions of dual-wavelength diode laser therapy. Participate in follow-up evaluations at three and six months post-treatment. Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up.
This study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM, addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Laser Therapy Group
Participants will receive non-ablative dual-wavelength diode laser therapy for Genitourinary Syndrome of Menopause (GSM). The intervention includes three monthly sessions using the Leonardo® Diode laser (Biolitec®) with wavelengths of 980 nm and 1470 nm. Each session lasts about 20 minutes and involves 8 pulses per centimeter along the vaginal canal. Local lidocaine gel is used as an anesthetic. Evaluations occur at baseline, 3 months, and 6 months post-treatment.
Leonardo® Diode laser
The intervention involves non-ablative dual-wavelength diode laser therapy for treating Genitourinary Syndrome of Menopause (GSM). This includes three monthly sessions of the Leonardo® Diode laser (Biolitec®), with wavelengths of 980 nm and 1470 nm, delivering 8 pulses per centimeter along the vaginal canal, using local lidocaine gel as an anesthetic. Evaluations are conducted at baseline, 3 months, and 6 months post-treatment.
Interventions
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Leonardo® Diode laser
The intervention involves non-ablative dual-wavelength diode laser therapy for treating Genitourinary Syndrome of Menopause (GSM). This includes three monthly sessions of the Leonardo® Diode laser (Biolitec®), with wavelengths of 980 nm and 1470 nm, delivering 8 pulses per centimeter along the vaginal canal, using local lidocaine gel as an anesthetic. Evaluations are conducted at baseline, 3 months, and 6 months post-treatment.
Eligibility Criteria
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Inclusion Criteria
* Sexually active.
* Experiencing physiological amenorrhea for more than 12 months.
* Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).
* Not using lubricants or hormonal therapy in the previous 6 months.
* Able to provide written informed consent.
Exclusion Criteria
* Pacemaker or other implanted electrode carriers.
* Severe multi-organ or neurological diseases.
* Active sexually transmitted infections.
* Moderate to severe uterine prolapse.
* Active urinary tract infections.
* Acute or chronic dermatological conditions in the vulvar or vaginal area.
* Active genital herpes.
* Active high-risk Human Papillomavirus (HPV).
* Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.
* Recent unhealed invasive or ablative surgeries.
* Bleeding disorders or anticoagulant therapy.
* Immunodeficiencies.
* Uncontrolled diabetes.
45 Years
73 Years
FEMALE
No
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Stefano Angioni
Professor
Principal Investigators
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Stefano Angioni
Role: PRINCIPAL_INVESTIGATOR
University of Cagliari
Locations
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Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
Cagliari, CA, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Elia D, Gambacciani M, Berreni N, Bohbot JM, Druckmann R, Geoffrion H, Haab F, Heiss N, Rygaloff N, Russo E. Genitourinary syndrome of menopause (GSM) and laser VEL: a review. Horm Mol Biol Clin Investig. 2019 Dec 19;41(1):/j/hmbci.2020.41.issue-1/hmbci-2019-0024/hmbci-2019-0024.xml. doi: 10.1515/hmbci-2019-0024.
Aguiar LB, Politano CA, Costa-Paiva L, Juliato CRT. Efficacy of Fractional CO2 Laser, Promestriene, and Vaginal Lubricant in the Treatment of Urinary Symptoms in Postmenopausal Women: A Randomized Clinical Trial. Lasers Surg Med. 2020 Oct;52(8):713-720. doi: 10.1002/lsm.23220. Epub 2020 Jan 28.
Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019.
Samuels JB, Garcia MA. Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women. Aesthet Surg J. 2019 Jan 1;39(1):83-93. doi: 10.1093/asj/sjy087.
Karcher C, Sadick N. Vaginal rejuvenation using energy-based devices. Int J Womens Dermatol. 2016 Jun 21;2(3):85-88. doi: 10.1016/j.ijwd.2016.05.003. eCollection 2016 Sep.
Eder SE. Early effect of fractional CO2 laser treatment in Post-menopausal women with vaginal atrophy. Laser Ther. 2018 Mar 31;27(1):41-47. doi: 10.5978/islsm.18-OR-04.
Gambacciani M, Levancini M, Russo E, Vacca L, Simoncini T, Cervigni M. Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause. Climacteric. 2018 Apr;21(2):148-152. doi: 10.1080/13697137.2018.1436538. Epub 2018 Feb 13.
Angioni S, Mais V, Pontis A, Peiretti M, Nappi L. First case of prophylactic salpingectomy with single port access laparoscopy and a new diode laser in a woman with BRCA mutation. Gynecol Oncol Case Rep. 2014 May 19;9:21-3. doi: 10.1016/j.gynor.2014.05.002. eCollection 2014 Aug.
Angioni S, Pontis A, Sorrentino F, Nappi L. Bilateral salpingo-oophorectomy and adhesiolysis with single port access laparoscopy and use of diode laser in a BRCA carrier. Eur J Gynaecol Oncol. 2015;36(4):479-81.
Nappi L, Angioni S, Sorrentino F, Cinnella G, Lombardi M, Greco P. Anti-Mullerian hormone trend evaluation after laparoscopic surgery of monolateral endometrioma using a new dual wavelengths laser system (DWLS) for hemostasis. Gynecol Endocrinol. 2016;32(1):34-7. doi: 10.3109/09513590.2015.1068754. Epub 2015 Aug 28.
Nappi L, Pontis A, Sorrentino F, Greco P, Angioni S. Hysteroscopic metroplasty for the septate uterus with diode laser: a pilot study. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:32-35. doi: 10.1016/j.ejogrb.2016.08.035. Epub 2016 Aug 31.
Nappi L, Sorrentino F, Angioni S, Pontis A, Litta P, Greco P. Feasibility of hysteroscopic endometrial polypectomy using a new dual wavelengths laser system (DWLS): preliminary results of a pilot study. Arch Gynecol Obstet. 2017 Jan;295(1):3-7. doi: 10.1007/s00404-016-4232-5. Epub 2016 Nov 11.
Esteban Manchado B, Lopez-Yarto M, Fernandez-Parra J, Rodriguez-Oliver A, Gonzalez-Paredes A, Lagana AS, Garzon S, Haimovich S. Office hysteroscopic metroplasty with diode laser for septate uterus: a multicenter cohort study. Minim Invasive Ther Allied Technol. 2022 Mar;31(3):441-447. doi: 10.1080/13645706.2020.1837181. Epub 2020 Oct 22.
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Maasoumi R, Lamyian M, Montazeri A, Azin SA, Aguilar-Vafaie ME, Hajizadeh E. The sexual quality of life-female (SQOL-F) questionnaire: translation and psychometric properties of the Iranian version. Reprod Health. 2013 May 5;10:25. doi: 10.1186/1742-4755-10-25.
Fahndrich E, Linden M. [Reliability and validity of the Visual Analogue Scale (VAS) (author's transl)]. Pharmacopsychiatria. 1982 May;15(3):90-4. doi: 10.1055/s-2007-1019515. German.
Bachmann GA, Phillips NA. Vaginal health prescription: possible next step in the management of genitourinary syndrome of menopause. Menopause. 2015 Feb;22(2):127-8. doi: 10.1097/GME.0000000000000414. No abstract available.
Dargie E, Holden RR, Pukall CF. The Vulvar Pain Assessment Questionnaire: Factor Structure, Preliminary Norms, Internal Consistency, and Test-Retest Reliability. J Sex Med. 2017 Dec;14(12):1585-1596. doi: 10.1016/j.jsxm.2017.10.072.
Vitale SG, Saponara S, Succu AG, Sicilia G, Martsidis K, D'Alterio MN, Angioni S. Efficacy and Safety of Non-Ablative Dual Wavelength Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Single-Center Prospective Study. Adv Ther. 2024 Dec;41(12):4617-4627. doi: 10.1007/s12325-024-03004-7. Epub 2024 Oct 29.
Other Identifiers
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NP/2022/4057
Identifier Type: -
Identifier Source: org_study_id
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