Clinical trial NCT04045379: LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Official title: LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postmenopausal Atrophic Vaginitis
Postmenopausal Symptoms
Genitourinary Symptoms
Keywords: postmenopause
atrophic vaginitis
vulvovaginal atrophy
treatment
LASER
Radiofrequency
estriol
strogen therapy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-08-05
Enrollment: 195
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.

Detailed description: Post menopause women with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study.

The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Estriol. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the estriol group, the application will be done by the patient, daily for 2 weeks and them twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube, to verify the correct use.

The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment.

Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or estriol; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by estrogen, LASER and radiofrequency; quality of life, sexual dysfunctions and complaints before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.

Eligibility criteria: Inclusion Criteria:

1. Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
2. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of of vulvovaginal atrophy:

   * Burning
   * Discomfort
   * Dryness
   * Cracks
   * Pruritus
   * Lack of vaginal lubrication
   * Penetration dyspareunia that began at the menopausal or postmenopausal transition
   * Decreased vaginal epithelium turgor and trophism
   * Deletion of mucous and skin folds.

The Exclusion criteria will be:

1. Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)
2. Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.

Primary outcomes:
measure: Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol
timeFrame: The evaluation will be done 180 days after treatment
measure: Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol
timeFrame: The evaluation will be done 180 days after treatment
Secondary outcomes:
measure: Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment
measure: Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment and 30, 90, 180 and 360 days after treatment
measure: Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment and 30 days after treatment
measure: Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment and 30 days after treatment
measure: Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment and 30 days after treatment
measure: Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment and 30 days after treatment
measure: Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The evaluation will occur pre treatment and 30 days after treatment
measure: Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
timeFrame: The pictures will be taken before and 30 days and 180 days after treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Unifesp
state: SP
Study officials:
affiliation: Professor
name: Zsuzsanna IK Jarmy - di Bella, PhD
role: STUDY_CHAIR
References: