Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.

Study Overview
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Brief Summary
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The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Detailed Description
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Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronical files.

Official Title
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Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.

Conditions
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Exposure Laser

Intervention / Treatment
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* Device: CO2 AcuPulse Laser
* Device: Sham Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Negative urine culture. Positive cough test. Normal Papanicolaou (PAP) test from the past 3 years. Exclusion Criteria: signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence. Overactive bladder. Previous bulking injections. Previous transvaginal mesh implant. Previous surgery for stress urinary incontinence. Presence of pelvic organ prolapse. Presence of an active or recurring genital infection or urinary tract infection. Previous laser-based or other energy-based treatments for gynecological indications. Vaginal bleeding of unknown reason. Pregnancy. Current pelvic floor physiotherapy. Current treatment with local or systemic hormone replacement therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 AcuPulse Laser treatment<br>Subjects with USI as diagnosed by cough test intended to receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. | Device: CO2 AcuPulse Laser<br>* Each subject will receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.<br>|
| Sham Comparator: Sham laser treatment<br>Subjects with USI as diagnosed by cough test intended to receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. | Device: Sham Laser<br>* Each subject will receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad weight test. | Pad weight results in grams. | 15 months from recruitment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary distress index 6 questionnaire. | Total questionnaire score. | 15 months from recruitment. | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire. | Total questionnaire score. | 15 months from recruitment. | 
| International Consultation of Incontinence questionnaire. | Total questionnaire score. | 15 months from recruitment. | 
| Cough test | cough test results. | 15 months from recruitment. | 
| Visual analogue scale. | Pain rated with the visual analogue score. | 15 months from recruitment. |