Genitourinary Syndrome of MenopauseGSMLASERNCT06503003
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
An observational study of Genitourinary Syndrome of Menopause, run by University of Cagliari at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local… Read more about this study
- Who is it for?
- Ages 45 to 73 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Leonardo® Diode laser
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 73 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of post-menopausal women aged 45-73 years who are experiencing symptoms of Genitourinary Syndrome of Menopause (GSM). These women are sexually active and have experienced physiological amenorrhea for more than 12 months. The participants have not used lubricants or hormonal therapy in the previous six months. The study targets those who cannot use or have not benefited from local estrogen-based therapies.
Who may be able to join
- Post-menopausal women aged 45-73 years.
- 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.
Who cannot join
- Untreated uterine or vulvovaginal cancers.
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
Cagliari, CA, 09042
Stefano Angioni, +3907051093399, sangioni@yahoo.it
About this study
The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are:
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.
Read more
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.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Leonardo® Diode laser
- Keywords
- Genitourinary Syndrome of Menopause, Diode laser, Vaginal Atrophy, Menopause, Sexual Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leonardo® Diode laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Leonardo® Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Dryness
Measurement of the change in vaginal dryness scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse vaginal dryness.
Measured: Baseline, 3 months, 6 months after the final laser treatment
Change in Burning Sensation
Measurement of the change in burning sensation scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse burning sensation.
Measured: Baseline, 3 months, and 6 months after the final laser treatment
Change in Pain During Intercourse (Dyspareunia)
Measurement of the change in pain during intercourse scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse pain during intercourse.
Measured: Baseline, 3 months, and 6 months after the final laser treatment
Change in Vaginal Health Index Score (VHIS)
Measurement of the change in the Vaginal Health Index Score (VHIS), which examines five aspects of vaginal health: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each component is rated on a scale from 1 (indicating severe vaginal atrophy) to 5 (indicating no clinical signs of vaginal atrophy), with a total score below 15 confirming vaginal atrophy. Higher scores indicate better vaginal health.
Measured: Baseline, 3 months, and 6 months after the final laser treatment
Change in Sexual Function
Measurement of the change in sexual function scores using the Female Sexual Function Index-6 (FSFI-6). The FSFI-6 is a six-item version of the Female Sexual Function Index-19 (FSFI-19) and includes one item from each original domain: desire, arousal, lubrication, orgasm, satisfaction, and pain. Responses range from 0 (no sexual activity) to 5 (optimal function), with higher scores indicating better sexual function. An FSFI-6 score of 19.0 or less indicates sexual dysfunction.
Measured: Baseline, 3 months, and 6 months after the final laser treatment
Change in Sexual Quality of Life
Measurement of the change in scores on the Sexual Quality of Life-Female (SQOL-F) questionnaire. The SQOL-F questionnaire consists of 18 items that assess sexual self-esteem, emotional well-being, and relationship issues. Scores range from 18 to 108, with higher scores indicating better sexual quality of life.
Measured: Baseline, 3 months, and 6 months after the final laser treatment
Change in Sexual Function
Measurement of the change in sexual function scores using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The PISQ-12 is a 12-item questionnaire used to evaluate sexual function in patients suffering from urinary incontinence or pelvic organ prolapse. It explores three domains: behavioral-emotive, physical, and partner-related, scored on a 5-point Likert scale from 0 (always) to 4 (never), with reverse scoring for the first four items. Higher scores indicate better sexual function.
Measured: Baseline, 3 months, and 6 months after the final laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
- Investigators
- Stefano Angioni, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503003
- Sponsor's protocol ID
- NP/2022/4057
- Acronym
- GSMLASER
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31855563Aguiar 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.
PubMed 31990089Knight 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.
PubMed 32010212Samuels 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.
PubMed 29726916Karcher 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.
PubMed 28492016Eder 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.
PubMed 29795970Gambacciani 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.
PubMed 29436235Angioni 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.
PubMed 25426409Angioni 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.
PubMed 26390708Nappi 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.
PubMed 26359914Nappi 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.
PubMed 27632410Nappi 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.
PubMed 27834002Esteban 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.
PubMed 33090039Rosen 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.
PubMed 10782451Maasoumi 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.
PubMed 23642126
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact
- ClinicalTrials.gov ID
- NCT06503003
- Acronym / sponsor ID
- GSMLASER / NP/2022/4057
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- Genitourinary Syndrome of Menopause, Diode laser, Vaginal Atrophy, Menopause, Sexual Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Therapy Group | – | Device: Leonardo® Diode laserParticipants 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. |
Who may qualify
- Ages
- 45 to 73 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of post-menopausal women aged 45-73 years who are experiencing symptoms of Genitourinary Syndrome of Menopause (GSM). These women are sexually active and have experienced physiological amenorrhea for more than 12 months. The participants have not used lubricants or hormonal therapy in the previous six months. The study targets those who cannot use or have not benefited from local estrogen-based therapies.
Key inclusion criteria (6 listed)
- Post-menopausal women aged 45-73 years.
- 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.
Key exclusion criteria (14 listed)
- Untreated uterine or vulvovaginal cancers.
- Pacemaker or other implanted electrode carriers.
- Severe multi-organ or neurological diseases.
- Active sexually transmitted infections.
- Moderate to severe uterine prolapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leonardo® Diode laserThe 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. | Device | Laser Therapy Group |
Primary outcome
Change in Vaginal Dryness
Time frame: Baseline, 3 months, 6 months after the final laser treatment
Measurement of the change in vaginal dryness scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse vaginal dryness.
Change in Burning Sensation
Time frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in burning sensation scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse burning sensation.
Change in Pain During Intercourse (Dyspareunia)
Time frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in pain during intercourse scores using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating worse pain during intercourse.
Change in Vaginal Health Index Score (VHIS)
Time frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in the Vaginal Health Index Score (VHIS), which examines five aspects of vaginal health: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each component is rated on a scale from 1 (indicating severe vaginal atrophy) to 5 (indicating no clinical signs of vaginal atrophy), with a total score below 15 confirming vaginal atrophy. Higher scores indicate better vaginal health.
Change in Sexual Function
Time frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in sexual function scores using the Female Sexual Function Index-6 (FSFI-6). The FSFI-6 is a six-item version of the Female Sexual Function Index-19 (FSFI-19) and includes one item from each original domain: desire, arousal, lubrication, orgasm, satisfaction, and pain. Responses range from 0 (no sexual activity) to 5 (optimal function), with higher scores indicating better sexual function. An FSFI-6 score of 19.0 or less indicates sexual dysfunction.
Change in Sexual Quality of Life
Time frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in scores on the Sexual Quality of Life-Female (SQOL-F) questionnaire. The SQOL-F questionnaire consists of 18 items that assess sexual self-esteem, emotional well-being, and relationship issues. Scores range from 18 to 108, with higher scores indicating better sexual quality of life.
Change in Sexual Function
Time frame: Baseline, 3 months, and 6 months after the final laser treatment
Measurement of the change in sexual function scores using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The PISQ-12 is a 12-item questionnaire used to evaluate sexual function in patients suffering from urinary incontinence or pelvic organ prolapse. It explores three domains: behavioral-emotive, physical, and partner-related, scored on a 5-point Likert scale from 0 (always) to 4 (never), with reverse scoring for the first four items. Higher scores indicate better sexual function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 31855563Elia 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.
- Background: PubMed 31990089Aguiar 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.
- Background: PubMed 32010212Knight 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.
- Background: PubMed 29726916Samuels 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.
- Background: PubMed 28492016Karcher 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.
- Background: PubMed 29795970Eder 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.
- Background: PubMed 29436235Gambacciani 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.
- Background: PubMed 25426409Angioni 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.
- Background: PubMed 26390708Angioni 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.
- Background: PubMed 26359914Nappi 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.
- Background: PubMed 27632410Nappi 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.
- Background: PubMed 27834002Nappi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Angioni principal investigator
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary Syndrome of Menopause, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Angioni (+3907051093399, sangioni@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaginal Dryness (time frame: Baseline, 3 months, 6 months after the final laser treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06503003, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.