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

NCT ID: NCT06508788

Last Updated: 2024-07-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Genitourinary Syndrome of Menopause

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CO2 laser cohort

Patients with a history of oncology and for whom a diagnosis of genitourinary syndrome is established and who are not eligible for treatment with hormonal therapy

CO2 laser

Intervention Type DEVICE

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

Interventions

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CO2 laser

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Carlos Ortega-Expósito

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carlos

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Carlos Ortega-Expósito

Role: primary

932607500 ext. 6814

Other Identifiers

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ICPS010/24

Identifier Type: -

Identifier Source: org_study_id

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