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

NCT ID: NCT05097456

Last Updated: 2022-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser treatment

carbon dioxide treatment

Group Type ACTIVE_COMPARATOR

carbon dioxide laser

Intervention Type DEVICE

carbon dioxide laser

Sham treatment

sham treatment

Group Type SHAM_COMPARATOR

sham laser

Intervention Type DEVICE

sham laser

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

carbon dioxide laser

carbon dioxide laser

Intervention Type DEVICE

sham laser

sham laser

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ROY LAUTERBACH MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam healthcare campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam health care campus

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0292-20-RMB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.