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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT05097456

Collaborator

(none)

125

Enrollment

Location

Arms

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: carbon dioxide laser Device: sham laser	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Nov 15, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pad weight test [From treatment up to 12 months post treatment]
Change in pad weight

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam health care campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Roy Lauterbach, MD, Rambam healthcare campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ROY LAUTERBACH MD, Principal investigator, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT05097456

Other Study ID Numbers:

0292-20-RMB

First Posted:

Oct 28, 2021

Last Update Posted:

Feb 7, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of Feb 7, 2022