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

Not Applicable

Completed

• Conditions: Exposure Laser
• Interventions: Device: Sham Laser; Device: CO2 AcuPulse Laser

• Registration Number: NCT02861391
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

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 Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Study Start: 2019-10-04
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham laser treatment	Sham Laser	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.
CO2 AcuPulse Laser treatment	CO2 AcuPulse Laser	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.

Primary Outcome Measures

Name	Time	Method
Pad weight test.	15 months from recruitment.	Pad weight results in grams.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel