Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment

NCT04717245 | Completed

• 1 other identifier: CAI
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. The best treatment for increasing genital trophism is still estrogen. However, there are women who can not use this therapy or do not want it. Therefore, there is a need for alternatives, such as ablation techniques: use of CO2 LASER and fractional radiofrequency. The study was carried out at the outpatient clinic of Lower Genital Tract ambulatory of the Discipline of Gynecology, Department of Obstetrics and Gynecology, Clinical Hospital, Faculty of Medicine, University of São Paulo, involving 75 women who were divided after randomization in three groups: Group 1 - treatment with topical vaginal promestriene (n = 25 patients); Group 2 - treatment with fractional CO2 LASER (n = 25 patients); Group 3 - fractional microablative radiofrequency treatment (n = 25 patients). An evaluation of the complaints were be performed through questionnaires on sexuality, quality of life and urinary incontinence, as well as biopsies of the vaginal wall for histomorphometric, immunohistochemical and molecular biology study before and after six months of treatment. The duration of the study were fifteen months.

Conditions

Vaginal Atrophy

Keywords

genital atrophy; fractional CO2 laser; microablative fractional radiofrequency; quality of life; sexuality; promestriene; Menopause genitourinary syndrome

Outcome Measures

Primary Outcomes (1)

• Life's quality questionnaire

  It was acessed at the beginnig and in the end of the treatment. We used the Short Form Health Survey 36 questionnaire for this parameter. It contains 36 items measuring eight dimensions, that vary the pontuation between 1-5 to 1-6. All but one of the 36 items are used to score the SF-36 eight domains that are aggregated in two summary measures, Physical and Mental components. Among the eight domains, three scales (Physical Functioning, Role-Physical, and Bodily Pain) contributes mostly to the Physical Component Summary (PCS) and three (Mental Health, Role-Emotional, and Social Functioning) contributes to the Mental Component Summary. The domains Vitality, General Health, and Social Functioning present noteworthy correlations with both summary componentNormalized scores below 50 are interpreted as below the generals population. The better is to have a higher pontuation.

  3-4 months

Secondary Outcomes (3)

• Sexuality questionnaire - Female Sexual Function Index

  3-4 months

• pH values

  3-4 months

• score symptoms

  3-4 months

Study Arms (3)

Fractional CO2 LASER

ACTIVE COMPARATOR

Vaginal fractional CO2 LASER 3 sessions applications

Other: Fractional CO2 LASER

Microablative fractional radiofrequency

ACTIVE COMPARATOR

Vaginal Microablative fractional radiofrequency 3 sessions application

Other: Microablative Fractional radiofrequency

Promestriene Vaginal

ACTIVE COMPARATOR

Promestriene vaginal use during 3 months

Drug: Promestriene Vaginal

Interventions

Promestriene Vaginal DRUG

Patients used promestriene vaginal cream for 3 months. The use was recommended to be diary fot the first 2 weeks, and then, repeat every 3 days.

Also known as: Promestrieno

Promestriene Vaginal

Fractional CO2 LASER OTHER

LASER treatment with fractional CO2 Laser was performed in 3 sessions with intervals of 4 weeks between them. Before each session, the patients underwent specular examination. Fractional CO2 LASER was applied following these parameters, fixed in all sessions: vagina wall - power40 W, dwel time 1000 mcs, spacing 1000 mcm and stack 2, vestibule - power 10W, dwel time 500mcs, spacing 300mcg and satck 1

Fractional CO2 LASER

Microablative Fractional radiofrequency OTHER

Microablative fractional radiofrequency was performed with the equipment calibrated in FRAXX mode, 45W, Low Energy program 40 milliseconds in the vaginal and introitus wall. Lidocaine spray was applied to vaginal introitus before the procedure. The patient was in the gynecological position. The vaginal speculum was placed and, afterwards, the vaginal antisepsis was performed with aqueous chlorhexidine and cleaning with 0.9% saline solution. All liquid contents were wiped off before beginning the procedure. The fractured tip will be pressed lightly and as perpendicular as possible into the vulvar or vaginal surface, ensuring full contact of all points in the tissue, starting at the lateral vaginal walls and from the proximal to the distal third.

Microablative fractional radiofrequency

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or superior to 40 years and under 65 years
• Clinical menopause - last menstrual period from 1 to 5 years from the date of recruitment
• FSH measurement\> 25 IU / ml, estrogen \<20 æg / ml
• Patients with vaginal atrophy and clinical and / or sexual symptoms
• Patients without hormonal treatment for at least five years

You may not qualify if:

• Whole Hymen
• Altered oncology cytology of the cervix and / or vagina
• Vaginal infections
• Connective tissue diseases
• Immunosuppression
• Coagulation change
• Diabetes Mellitus
• Thyroid diseases
• Use of systemic or local feminine hormones
• Use of other substances with estrogenic properties

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Disciplina de ginecologia - departamento de ginecologia e obstetrícia - faculdade de medicina da USP

São Paulo, 01246-100, Brazil

Location

Related Publications (1)

• Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.

  PMID: 38714422 DERIVED

MeSH Terms

Conditions

Sexuality

Interventions

promestriene

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Jose Maria Soares Junior, PHD

  Universidade de São Paulo departamento de ginecologia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, 75 patients were included, divided into these three groups: Group 1 - Treatment with topical vaginal promestriene - 25 patients were included in this group Group 2 - Treatment with fractional CO2 LASER - 25 patients were included in this group Group 3 - Treatment with microablative fractional radiofrequency - 25 patients were included in this group

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: January 22, 2021
• Study Start: October 25, 2018
• Primary Completion: March 7, 2019
• Study Completion: February 18, 2020
• Last Updated: January 25, 2021

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)