Clinical trial NCT05305209: Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: GSM (genitourinary syndrome of menopause)
laser treatment
postmenopausal condition
urinary incontinence
vulvovaginal atrophy
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Antonia Maria Ruiz Moreno
name: María Dolores Martínez Colmena
name: María del Carmen Iniesta Moreno
name: María Lydia Serra Llosa
First posted: 2022-03-31
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Women of any age with established menopause of 5 years or more who report genitourinary discomfort, dyspareunia, sequelae, genital atrophy, voiding discomfort, voiding urgency or urinary incontinence. Postmenopausal status is defined if patients have at least 12 continuous months of amenorrhea for no other apparent reason or permanently elevated follicle-stimulating hormone (FSH) blood levels (≥30 mIU/mL).
* Patients who have had cancer treatment already completed and in the process of remission.
* Sexually active
* Nulliparous or who have had vaginal deliveries or caesarean section
* That they do not receive hormone replacement therapy in any of its routes of administration. If you received HRT, 4 months must have elapsed since stopping treatment before starting the trial protocol.
* Motivated and committed to complete the trial

Exclusion Criteria:

* According to the pelvic organ prolapse quantification system \[POP-Q\], POP\>Stage 2, , severe urinary or fecal incontinence (FI) or any disease that could influence the study protocol. In addition, patients will be advised to refrain from vaginal practices for three days prior to each biopsy (one at the beginning and one at the end of treatment).
* Women who are not sexually active, do not have coital relationships, either with a partner or alone
* Women with recurrent cystitis or candidiasis
* Women with little motivation to participate in the trial
* Minors
* Patients who do not have the ability to comprehend or understand what participation in a clinical trial entail
* Patients with severe psychiatric pathology (depression, anxiety)
* Patients with degenerative neurological pathology: either cognitive impairment or ALS, MS, diabetic neuropathy, etc.
* Patients with neuropathic genital pain (neuralgia or pudendal nerve entrapment)
* Vulvodynia, hyperalgesia, or genital allodynia
* Post-pelvic surgery of less than 3 months

Primary outcomes:
measure: Change from Baseline in Vaginal pH
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
measure: Change from Baseline in the deep musculature with the PERFECT protocol
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
measure: Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Secondary outcomes:
measure: Analysis of the impact on QoL (Quality of life) with the SF-12 (Short Form) health questionnaire.
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
measure: Analysis of the impact on QoL (Quality of life) with Cervantes Scale
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
measure: Assessment of pain with the CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
measure: Evaluation of the impact of pelvic floor dysfunction symptoms with the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
measure: Assesment of menopausal symptoms with the Menopause Rating Scale (MSR).
timeFrame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: University of Málaga
Study officials:
affiliation: University of Malaga
name: Rocío Martín-Valero, PhD
role: PRINCIPAL_INVESTIGATOR
References: