Exposure Laser Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
Verified date | January 2023 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | January 30, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam health care campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pad weight test. | Pad weight results in grams. | 15 months from recruitment. | |
Secondary | Urinary distress index 6 questionnaire. | Total questionnaire score. | 15 months from recruitment. | |
Secondary | Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire. | Total questionnaire score. | 15 months from recruitment. | |
Secondary | International Consultation of Incontinence questionnaire. | Total questionnaire score. | 15 months from recruitment. | |
Secondary | Cough test | cough test results. | 15 months from recruitment. | |
Secondary | Visual analogue scale. | Pain rated with the visual analogue score. | 15 months from recruitment. |
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