Carbon dioxide (CO2) Surgical Laser for Treatment of Stress Urinary Incontinence in Women – a RCT study

Not Applicable

Recruiting

• Conditions: stress urinary incontinence; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12617000099325
• Lead Sponsor: Monash Health, Pelvic Floor Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-18
• Last Update Posted: 4 February 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the subjective cure rate (positive answer to leaks when you cough or sneeze or leaks when physically active/exercising on ICIQ-UI) of the CO2 surgical laser against sham [3 months after laser treatment of female stress incontinence]