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

Primary Purpose

Exposure Laser

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CO2 AcuPulse Laser
Sham Laser
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exposure Laser

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Negative urine culture.
  • Positive for USI in urodynamic testing.
  • Normal Papanicolaou (PAP) test from the recent year.
  • Negative for vaginal wall prolapse.
  • Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

  • Pregnant subjects.
  • Subjects with repeated urinary tract infections or repeated infections with Candida or Herpes (more than twice a year).
  • Previous surgery in the treatment area in the previous 9 months.
  • Unexplained vaginal bleeding.

Sites / Locations

  • Rambam health care campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CO2 AcuPulse Laser treatment

Sham laser treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pad weight test.
Pad weight results in grams.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2016
Last Updated
January 12, 2023
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02861391
Brief Title
Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.
Official Title
Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
January 30, 2022 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exposure Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO2 AcuPulse Laser treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham laser treatment
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CO2 AcuPulse Laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pad weight test.
Description
Pad weight results in grams.
Time Frame
15 months from recruitment.
Secondary Outcome Measure Information:
Title
Urinary distress index 6 questionnaire.
Description
Total questionnaire score.
Time Frame
15 months from recruitment.
Title
Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.
Description
Total questionnaire score.
Time Frame
15 months from recruitment.
Title
International Consultation of Incontinence questionnaire.
Description
Total questionnaire score.
Time Frame
15 months from recruitment.
Title
Cough test
Description
cough test results.
Time Frame
15 months from recruitment.
Title
Visual analogue scale.
Description
Pain rated with the visual analogue score.
Time Frame
15 months from recruitment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lior Lowenstein, MD
Organizational Affiliation
Rambam Health Care 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

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

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