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

NCT ID: NCT05305209

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-12-15

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).

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

They will receive the k-laser treatment with the k-laser Cube Plus 30 device

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: OTHER

The patients will receive 12 minutes of intravaginal application with an average power of 1 watios and total applied energy of 720J and an extracavitary application for 4 minutes with an average power of 3 watios and a total dose of 720J with all effects at 200%, twice a week for 6 weeks.

Control Group

They will receive a sham treatment with the k-laser Cube Plus 30 device turned off

Group Type: PLACEBO_COMPARATOR

Control Group

Intervention Type: OTHER

The patients will receive 12 minutes of intravaginal application and 4 minutes of extracavitary application, twice a week for 6 weeks. The difference compared to the intervention of group 1 is that the device will be off and therefore will not emit energy.

Interventions

Intervention group

The patients will receive 12 minutes of intravaginal application with an average power of 1 watios and total applied energy of 720J and an extracavitary application for 4 minutes with an average power of 3 watios and a total dose of 720J with all effects at 200%, twice a week for 6 weeks.

Intervention Type: OTHER

Control Group

The patients will receive 12 minutes of intravaginal application and 4 minutes of extracavitary application, twice a week for 6 weeks. The difference compared to the intervention of group 1 is that the device will be off and therefore will not emit energy.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Antonia Maria Ruiz Moreno

UNKNOWN

Sponsor Role: collaborator

María Dolores Martínez Colmena

UNKNOWN

Sponsor Role: collaborator

María del Carmen Iniesta Moreno

UNKNOWN

Sponsor Role: collaborator

María Lydia Serra Llosa

UNKNOWN

Sponsor Role: collaborator

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Rocío Martín Valero

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rocío Martín-Valero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

University of Málaga

Málaga, , Spain

Countries

Spain

Central Contacts

Rocío Martín-Valero, PhD

Role: CONTACT

rovalemas@uma.es

34 951 952 858

Rocío Martín-Valero, PhD

Role: CONTACT

34 951 952 858

Other Identifiers

UMA _SGM_2022

Identifier Type: -

Identifier Source: org_study_id