Stress Urinary Incontinence
Conditions
Brief summary
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.
Detailed description
Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronic files.
Interventions
DEVICEcarbon dioxide laser
carbon dioxide laser
DEVICEsham laser
sham laser
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Negative urine analysis. * Normal Pap smear test from the recent 3 years. * No previous gynecological laser treatments. * Able and willing to comply with the treatment/follow-up schedule and requirements.
Exclusion criteria
* Active genital infection. * Subject presenting abnormal Pap result from the last three years. * Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year). * Transvaginal mesh implant. * Serious systemic disease or any chronic condition that could interfere with study compliance. * Any vaginal bleeding of unknown reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pad weight test | From treatment up to 12 months post treatment | Change in pad weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough test | From treatment up to 12 months post treatment | Positive cough test |
| Urinary distress index questionnaire | From treatment up to 12 months post treatment | Change in urinary distress index questionnaire scores |
| International consultation on incontinence questionnaire-urinary incontinence | From treatment up to 12 months post treatment | Change in international consultation on incontinence questionnaire-urinary incontinence scores |
| Pelvic organ prolapse/urinary incontinence sexual questionnaire | From treatment up to 12 months post treatment | Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores |
Countries
Israel
Outcome results
None listed