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

Recruiting

• Conditions: Genitourinary Syndrome of Menopause
• Interventions: Device: CO2 laser

• Registration Number: NCT06508788
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-18
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CO2 laser cohort	CO2 laser	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

Primary Outcome Measures

Name	Time	Method
Effectiveness	12 months	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

Secondary Outcome Measures

Name	Time	Method
Duration	12 months	To determine the durability of the effects produced by vaginal laser therapy
Security	12 months	To determine the safety (side effects) of vaginal laser therapy

Trial Locations

Locations (1)

Carlos; 🇪🇸 Hospitalet de Llobregat, Cataluña, Spain