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Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients

Combinación Del láser Vaginal Con un Gel Niosomal Hidratante y Reparador en el Tratamiento Del síndrome Genitourinario en Pacientes oncológicas

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06508788
Enrollment
30
Registered
2024-07-18
Start date
2024-07-01
Completion date
2026-07-01
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary Syndrome of Menopause

Keywords

Genitourinary Syndrome of Menopause, CO2 laser

Brief summary

Vaginal laser together with the use of moisturizing and repairing gels could be an effective therapy for the treatment of genitourinary syndrome in women with a history of neoplasia in whom the use of estrogens is not recommended. The purpose of this study is to evaluate the effectiveness of vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in this group of patients.

Interventions

DEVICECO2 laser

Application of CO2 vulvo-vaginal laser according to standard therapy and moisturizing gels

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with an established SGM diagnosis. * Patients with a history of neoplasia in whom the use of estrogens as the first alternative for the treatment of GMS is not recommended.

Exclusion criteria

* Patients with concomitant vulvovaginal pathology. * Patients with a diagnosis of pelvic organ prolapse grade II or greater.

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness12 monthsTo evaluate the effectiveness of CO2 vaginal laser together with adjuvant treatment with a hydrating and repairing niosomal gel as a beneficial treatment in patients with a history of neoplasia in whom the use of estrogens is not recommended

Secondary

MeasureTime frameDescription
Security12 monthsTo determine the safety (side effects) of vaginal laser therapy
Duration12 monthsTo determine the durability of the effects produced by vaginal laser therapy

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026