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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02861391
Other study ID # 0205-16-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2019
Est. completion date January 30, 2022

Study information

Verified date January 2023
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CO2 AcuPulse Laser
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.
Sham Laser
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.

Locations

Country Name City State
Israel Rambam health care campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

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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