Back to resultsCarbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
carbon dioxide laser
sham laser
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- Rambam health care campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Laser treatment
Sham treatment
Arm Description
carbon dioxide treatment
sham treatment
Outcomes
Primary Outcome Measures
Pad weight test
Change in pad weight
Secondary Outcome Measures
Cough test
Positive cough test
Urinary distress index questionnaire
Change in urinary distress index questionnaire scores
International consultation on incontinence questionnaire-urinary incontinence
Change in international consultation on incontinence questionnaire-urinary incontinence scores
Pelvic organ prolapse/urinary incontinence sexual questionnaire
Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores
Full Information
NCT ID
NCT05097456
First Posted
October 4, 2021
Last Updated
February 3, 2022
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT05097456
Brief Title
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms
Official Title
Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser treatment
Arm Type
Active Comparator
Arm Description
carbon dioxide treatment
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
sham treatment
Intervention Type
Device
Intervention Name(s)
carbon dioxide laser
Intervention Description
carbon dioxide laser
Intervention Type
Device
Intervention Name(s)
sham laser
Intervention Description
sham laser
Primary Outcome Measure Information:
Title
Pad weight test
Description
Change in pad weight
Time Frame
From treatment up to 12 months post treatment
Secondary Outcome Measure Information:
Title
Cough test
Description
Positive cough test
Time Frame
From treatment up to 12 months post treatment
Title
Urinary distress index questionnaire
Description
Change in urinary distress index questionnaire scores
Time Frame
From treatment up to 12 months post treatment
Title
International consultation on incontinence questionnaire-urinary incontinence
Description
Change in international consultation on incontinence questionnaire-urinary incontinence scores
Time Frame
From treatment up to 12 months post treatment
Title
Pelvic organ prolapse/urinary incontinence sexual questionnaire
Description
Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores
Time Frame
From treatment up to 12 months post treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam healthcare campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms
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