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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treatment | Active Comparator | carbon dioxide treatment |
|
| Sham treatment | Sham Comparator | sham treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon dioxide laser | Device | carbon dioxide laser |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pad weight test | Change in pad weight | From treatment up to 12 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cough test | Positive cough test | From treatment up to 12 months post treatment |
| Urinary distress index questionnaire | Change in urinary distress index questionnaire scores |
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Inclusion Criteria:
Exclusion Criteria:
Female patients
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| Name | Affiliation | Role |
|---|---|---|
| Roy Lauterbach, MD | Rambam healthcare campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| sham laser |
| Device |
sham laser |
|
| From treatment up to 12 months post treatment |
| International consultation on incontinence questionnaire-urinary incontinence | Change in international consultation on incontinence questionnaire-urinary incontinence scores | From treatment up to 12 months post treatment |
| Pelvic organ prolapse/urinary incontinence sexual questionnaire | Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores | From treatment up to 12 months post treatment |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |