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

NCT06508788 | Recruiting

• 1 other identifier: ICPS010/24
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause

Keywords

Genitourinary Syndrome of Menopause; CO2 laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Security

  12 months

• Duration

  12 months

Study Arms (1)

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

Interventions

CO2 laser DEVICE

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

CO2 laser cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Carlos

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

RECRUITING

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 18, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)