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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 AcuPulse Laser treatment | Experimental | 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. |
|
| Sham laser treatment | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 AcuPulse Laser | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pad weight test. | Pad weight results in grams. | 15 months from recruitment. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lior Lowenstein, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| Sham Laser | Device | 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. |
|
| 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. |