Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms

Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: carbon dioxide laser; Device: sham laser

Detailed Description

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic 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: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Negative urine analysis.
• Normal Pap smear test from the recent 3 years.
• No previous gynecological laser treatments.
• Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

• Active genital infection.
• Subject presenting abnormal Pap result from the last three years.
• Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
• Transvaginal mesh implant.
• Serious systemic disease or any chronic condition that could interfere with study compliance.
• Any vaginal bleeding of unknown reason.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laser treatment; carbon dioxide treatment	Device: carbon dioxide laser; carbon dioxide laser
Sham Comparator: Sham treatment; sham treatment	Device: sham laser; sham laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pad weight test	Change in pad weight	From treatment up to 12 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough test	Positive cough test	From treatment up to 12 months post treatment
Urinary distress index questionnaire	Change in urinary distress index questionnaire scores	From treatment up to 12 months post treatment
International consultation on incontinence questionnaire-urinary incontinence	Change in international consultation on incontinence questionnaire-urinary incontinence scores	From treatment up to 12 months post treatment
Pelvic organ prolapse/urinary incontinence sexual questionnaire	Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores	From treatment up to 12 months post treatment

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 0292-20-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