None listed
Conditions
Brief summary
Stress urinary incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Management of stress urinary incontinence includes both conservative therapy and more invasive surgical intervention. The current main conservative approach to treatment of stress urinary incontinence is pelvic floor muscle therapy (PMFT). PFMT improves stress incontinence symptoms by 56 %. However, pelvic floor muscle therapy has poor long term compliance and women then choose more invasive surgical treatment. Fractionated CO2 laser has been established for use in dermatological and dental applications to stimulate collagen neogenesis and skin and tissue remodeling. Recently, use of fractionated CO2 laser has been introduced and has been successfully used for vulvovaginal atrophy. The rationale for the use of CO2 laser for treatment of SUI is to trigger tissue remodeling and regeneration to improve urethral support. Women may prefer to vaginal CO2 laser treatment as a conservative option to treat SUI over surgical intervention due to the morbidity of surgical intervention. The aim of this study is to evaluate the use of fractionated CO2 laser treatment in combination with physiotherapy as a potential treatment for women with stress urinary incontinence over physiotherapy alone.
Interventions
Fractionated CO2 surgical laser using the Lumenis Acupulse CO2 laser system and the AcuScan 120 microscanner to provide fractional treatment, delivered by a consultant urogynaecologist
Mode of delivery will be face to face and will be provided individually. Through the use of the scanner, the laser energy is delivered in a fractional manner, from 7.5-12.5 millijoule with a 5-25% density, a penetration depth of 600 micro millimeter from the 10o’clock to 2 o’clock position, starting at the top of
Fractionated CO2 surgical laser using the Lumenis Acupulse CO2 laser system and the AcuScan 120 microscanner to provide fractional treatment, delivered by a consultant urogynaecologist Mode of delivery will be face to face and will be provided individually. Through the use of the scanner, the laser energy is delivered in a fractional manner, from 7.5-12.5 millijoule with a 5-25% density, a penetration depth of 600 micro millimeter from the 10o’clock to 2 o’clock position, starting at the top of the vagina up to 5mm from the introitus. (Lumenis protocol). This will be delivered over 3x 5minute sessions, once every 4 weeks over 3 months and be performed in an urban urogynaecological clinic.
Sponsors
Monash Health, Pelvic Floor Clinic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed