CO2 Surgical Laser for Treatment of Stress Urinary Incontinence in Women – a RCT study

Monash Health, Pelvic Floor Clinic0 个研究点目标入组 200 人开始时间: 2017年1月18日最近更新: 2019年2月4日

适应症

试验速览

暂无简介。

•All participants with symptoms of stress urinary incontinence
•between the ages of 18-80 years with objective stress urinary incontinence (based on one of three objective measures of either positive cough stress test or urodynamic stress incontinence or positive 24h pad weigh test (>4g))
•desire conservative management
•Participants will have had supervised pelvic floor muscle therapy in the last 12 months
•Capable of providing informed consent and able to return for follow up.
•Negative urinalysis
•Normal Papanicolaou (PAP) test within the last 2 years

•Pregnant subjects
•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
•Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year)
•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

发起方

Monash Health, Pelvic Floor Clinic