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

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.

Study Overview

• Status: Recruiting
• Conditions: Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: CO2 laser

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Spain
  • Cataluña
    • Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Recruiting
      • Carlos
      • Contact: Carlos Ortega-Expósito; Phone Number: 6814 932607500; Email: cortegae@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: CO2 laser; Application of CO2 vulvo-vaginal laser according to standard therapy and moisturizing gels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	To 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security	To determine the safety (side effects) of vaginal laser therapy	12 months
Duration	To determine the durability of the effects produced by vaginal laser therapy	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: CO2 laser; Genitourinary Syndrome of Menopause
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: ICPS010/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No