Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women (LASER_2022)

Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women (LASER_2022)

ClinicalTrials.gov ID: NCT05305209
Sponsor: University of Malaga
Information provided by: Rocío Martín Valero, University of Malaga (Responsible Party)
Last Update Posted: 2022-05-18

Brief Summary:
This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol.

The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women.

The study population is female subjects > 18 years old with symptoms of genitourinary syndrome of menopause (GSM) who have not menstruated for at least 5 years.

Detailed Description:
The clinical data will be analysed by comparing post-treatment data with the baseline data (clinical history, compliance with selection, inclusion and exclusion requirements, assessment of the muscle and pH, and questionnaires). The follow-up is for 6 weeks after the procedure, a physical examination will be passed again to assess whether the effects on the tissue are maintained once the treatment is finished (coloration, hydration, and mobility of the tissue). Two biopsies will be taken, once at the beginning of treatment and another at the end.

The symptoms of SGM worsen as the age of the subject advances, which is why a treatment is required that improves the symptoms in the long term and maintains them once the treatment is finished. For this reason, the objective is to carry out a randomized control study with a new K-Laser Cube device that minimizes the possible risks of conventional vaginal laser therapy.

The hypothesis is that women who will undergo vaginal K-Laser treatment will report an improvement not only in SGM, but also in pelvic floor dysfunctions. The objective in this pilot study will be to evaluate the effects of K-laser treatment on pelvic floor dysfunctions using validated and commonly used questionnaires.

Changes in vaginal pH measured by FSFI (Female Sexual Function Index) questionnaire and changes in the deep musculature with the PERFECT protocol and the OXFORD scale will be the primary endpoints of the study. The secondary endpoints include quality of life changes with the SF-12 (Short Form) health questionnaire and Cervantes Scale, CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire, PFDI-20 (Pelvic Floor Distress Inventory) questionnaire and the Menopause Rating Scale (MSR).

Official Title:
Efficacy of K-laser as a Therapeutic Treatment of the Symptoms of Genitourinary Syndrome of Menopause (SGM) in Postmenopausal Women: a Randomized Clinical Trial

Intervention / Treatment:
- Other: Intervention group
- Other: Control Group

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