LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 07/31/2019 |
| První předloženo: | 05/19/2019 |
| Odhadovaná registrace vložena: | 07/31/2019 |
| První zveřejnění: | 08/04/2019 |
| Poslední aktualizace byla odeslána: | 07/31/2019 |
| Poslední aktualizace zveřejněna: | 08/04/2019 |
| Aktuální datum zahájení studie: | 08/04/2019 |
| Odhadované datum dokončení primární: | 07/31/2021 |
| Odhadované datum dokončení studie: | 07/31/2023 |
Stav nebo nemoc
Intervence / léčba
Procedure: LASER
Procedure: Micro Ablative Radiofrequency
Drug: Estriol
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Active Comparator: LASER The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 (carbon dioxide)LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days | Procedure: LASER Use of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured. |
| Active Comparator: Micro Ablative Radiofrequency The patients will receive 3 consecutive applications of intravaginal and vulvar MIcro ablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days | Procedure: Micro Ablative Radiofrequency Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured. |
| Active Comparator: Estriol The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use. | Drug: Estriol The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week. |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 40 Years Na 40 Years |
| Pohlaví způsobilá ke studiu | Female |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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. |
Výsledek
Primární výsledná opatření
1. Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol [The evaluation will be done 180 days after treatment]
2. Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol [The evaluation will be done 180 days after treatment]
Měření sekundárních výsledků
1. Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment]
2. Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment and 30, 90, 180 and 360 days after treatment]
3. Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment and 30 days after treatment]
4. Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment and 30 days after treatment]
5. Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment and 30 days after treatment]
6. Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment and 30 days after treatment]
7. Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. [The evaluation will occur pre treatment and 30 days after treatment]
8. Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. [The pictures will be taken before and 30 days and 180 days after treatment.]
