Er-YAG Surgical Laser for Treatment of Vaginal Laxity – a RCT study

Anna Rosamilia0 个研究点目标入组 76 人开始时间: 2019年8月9日最近更新: 2019年8月26日

试验速览

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•All participants between the ages of 18-80 with subjective vaginal laxity as defined as a score of 3 or less on the vaginal laxity scale.
•Capable of providing informed consent and able to return for follow up.
•Normal Cervical screening test within last five years or Papanicolau Test within 2 years.

•Pregnant subjects or women less than 12-months post-partum
•Actively breastfeeding or ceased breastfeeding less than three menstrual cycles
•Any previous prolapse surgery
•Previous surgery in the treatment area in the last year
•Active genital infection
•Subject presenting with abnormal PAP result from the last three years with any of the findings according to the Bethesda (2001) system classification
•Systemic steroids use within the last 3 months
•Vaginal lubricants within 7 days prior to enrollment
•Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system
•Transvaginal mesh or sling implant
•Serious systemic disease or any chronic condition that could interfere with study compliance
•Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
•Other contraindications to laser treatment: UTI, injuries of bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder disorder or use of photosensitivity medications, abnormal scarring, scarring, excessive sun exposure, preoperative histology findings indicative of malignancy, anatomic findings consistent with the diagnosis

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