Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.

Exposure Laser Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861391
• Other study ID #: 0205-16-RMB
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Exposure Laser
• Urinary Incontinence, Stress

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.