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

NCT05305209 | Unknown

• 1 other identifier: UMA _SGM_2022
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause

Keywords

GSM (genitourinary syndrome of menopause); laser treatment; postmenopausal condition; urinary incontinence; vulvovaginal atrophy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Vaginal pH

  During the physical examination a sample of the mucosa will be extracted to check the acidity of the pH. This is a marker of the health of the vaginal flora and abnormalities in pH values will be determined by hormonal imbalances of oestrogens. A pH\> 4.5 refers to a decrease in local vaginal defenses which predisposes to infections or inflammatory processes. The pH analysis is a valid tool to diagnose menopause equivalent to an analysis of the levels of the follicle-stimulating molecule (FSH) non-invasive and inexpensive.

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

• Change from Baseline in the deep musculature with the PERFECT protocol

  Digital evaluation is essential during the examination of the pelvic floor muscles. For this, digital palpation and a pressure gauge will be used. Digital assessment is performed by inserting the index and middle fingers into the distal 3 centimetres of the vagina in a frontal plane. The PERFECT protocol is described as an acronym for evaluating the main components of pelvic floor muscle contractility. The components are: P (power, score muscle strength according to the OXFORD scale), E (endurance, time the maximum contraction is maintained without loss of strength), R (repetitions, number of contractions with intervals of 4 to 10 seconds), F (number of fast contractions followed after a rest of 1 minute), ECT (every contraction timed: each contraction measured) that consists in evaluating each contraction before the beginning of the treatment, which allows individualizing the program.

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

• Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.

  FSFI questionnaire assesses sexual function in women with pelvic floor dysfunction. It consists of 6 domains and 19 items (Cronbach's alpha coefficient =0.85). The maximum score is 36.0 (high level of sexual functional) and minimum score is 2.0 (low level of sexual functional). The domains are: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), pain (3 items).

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

Secondary Outcomes (5)

• Analysis of the impact on QoL (Quality of life) with the SF-12 (Short Form) health questionnaire.

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

• Analysis of the impact on QoL (Quality of life) with Cervantes Scale

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

• Assessment of pain with the CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

• Evaluation of the impact of pelvic floor dysfunction symptoms with the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

• Assesment of menopausal symptoms with the Menopause Rating Scale (MSR).

  The evaluation will be done at baseline before treatment and 6 weeks post treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Intervention group

Control Group

PLACEBO COMPARATOR

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

Other: Control Group

Interventions

Intervention group 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.

Intervention group

Control Group 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.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaga: lead
• Antonia Maria Ruiz Moreno: collaborator
• María Dolores Martínez Colmena: collaborator
• María del Carmen Iniesta Moreno: collaborator
• María Lydia Serra Llosa: collaborator

Study Sites (1)

University of Málaga

Málaga, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rocío Martín-Valero, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocío Martín-Valero, PhD

CONTACT

34 951 952 858; rovalemas@uma.es

Rocío Martín-Valero, PhD

CONTACT

34 951 952 858

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 31, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 15, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)