LASER and Radiofrequency as Alternative Treatment of Vaginal Vulvar Atrophy in Women Treated for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Clinical Improvement of signs and symptoms of vulvovaginal atrophy with intravaginal LASER, Micro Ablative Radiofrequency, and topic promestriene
研究概览
简要总结
This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.
详细描述
Women treated for breast cancer 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 Promestriene. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the promestriene group, the application will be done by the patient, daily for 2 weeks and then twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the promestriene 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 promestriene; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by promestriene, LASER and radiofrequency; quality of life, sexual dysfunctions and complains before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
the outcomes assessor will not have access to the treatment that was used in each patient.
the investigator will not have acess to the treatment that was used in each group
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy
- •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 vulvovaginal atrophy:
- •Discomfort
- •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.
- •Absence of vaginal surgical procedure in the last year
- •Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0
排除标准
- •Active genital infection
- •Active infection of HPV (human papillomavirus) or Herpes
- •users of medications with estrogenic effect (digoxin and other chemicals)
- •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
研究组 & 干预措施
LASER
The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days
干预措施: LASER (Procedure)
Micro Ablative Radiofrequency
The patients will receive 3 consecutive applications of intravaginal and vulvar MIcroablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days
干预措施: Micro Ablative Radiofrequency (Procedure)
Promestriene
The patient will use intravaginal promestriene, 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 promestriene tube to verify the correct use.
干预措施: Promestriene (Drug)
结局指标
主要结局
Clinical Improvement of signs and symptoms of vulvovaginal atrophy with intravaginal LASER, Micro Ablative Radiofrequency, and topic promestriene
时间窗: The evaluation will be done 90 days after treatment]
Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared
Satisfaction with treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic promestriene for women treated for breast cancer, with genitourinary atrophy syndrome
时间窗: The evaluation will be done 90 days after treatment
Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared
次要结局
- Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.(The evaluation will occur pre-treatment and 30 and 180 days after treatment])
- Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic promestriene(The evaluation will occur pre-treatment 30, 90 , 180 and 360 days after treatment])
- Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.(The evaluation will occur pre-treatment and 30 and 180 days after treatment)
- Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.(The evaluation will occur pre-treatment and 30 and 180 and 360 days after treatment])
- Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.(The evaluation will occur pre-treatment and 30 180 and 360 days after treatment)
- Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.(The evaluation will occur pre-treatment and 30 and 180 days after treatment)
- Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic promestriene(The evaluation will occur pre-treatment and 30, 90, 180 and 360 days after treatment)
- Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.(The pictures will be taken before and 30 days and 180 days after treatment.])
研究者
Ana Maria Homem de Mello Bianchi
Principal investigador
Federal University of São Paulo