Rambam health care campus
Haifa, Israel
NCT Number: NCT02861391
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.
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Notify Me18 year–70 year
Female
Interventional
Not applicable
Haifa, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 15 months from recruitment.
Pad weight results in grams.
Time frame: 15 months from recruitment.
Total questionnaire score.
Time frame: 15 months from recruitment.
Total questionnaire score.
Time frame: 15 months from recruitment.
Total questionnaire score.
Time frame: 15 months from recruitment.
cough test results.
Time frame: 15 months from recruitment.
Pain rated with the visual analogue score.
Rambam Health Care Campus
Other
Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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