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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHospital Universitari de Bellvitge

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with concomitant vulvovaginal pathology.

Patients with a diagnosis of pelvic organ prolapse grade II or greater.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CO2 laser

    Device

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CO2 laser cohort1 intervention

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

Security

To determine the safety (side effects) of vaginal laser therapy

Time frame
12 months
2

Duration

To determine the durability of the effects produced by vaginal laser therapy

Time frame
12 months

Other outcomes

Sponsors and contacts

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