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

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

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.

Study Overview

• Status: Completed
• Conditions: Exposure Laser
• Intervention / Treatment: Device: CO2 AcuPulse Laser; Device: Sham Laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CO2 AcuPulse Laser treatment; Subjects with USI as diagnosed by cough test intended to receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.	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 Comparator: Sham laser treatment; Subjects with USI as diagnosed by cough test intended to receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pad weight test.	Pad weight results in grams.	15 months from recruitment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary distress index 6 questionnaire.	Total questionnaire score.	15 months from recruitment.
Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.	Total questionnaire score.	15 months from recruitment.
International Consultation of Incontinence questionnaire.	Total questionnaire score.	15 months from recruitment.
Cough test	cough test results.	15 months from recruitment.
Visual analogue scale.	Pain rated with the visual analogue score.	15 months from recruitment.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Lior Lowenstein, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 0205-16-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No