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

NCT ID: NCT02861391

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2022-01-30

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.

Conditions

Exposure Laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CO2 AcuPulse Laser treatment

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.

Group Type: EXPERIMENTAL

CO2 AcuPulse Laser

Intervention Type: DEVICE

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.

Sham laser 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.

Group Type: SHAM_COMPARATOR

Sham Laser

Intervention Type: DEVICE

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.

Interventions

CO2 AcuPulse Laser

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

Sham Laser

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

ROY LAUTERBACH MD

Dr. Roy Lauterbach

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lior Lowenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam health care campus

Haifa, , Israel

Countries

Israel

Other Identifiers

0205-16-RMB

Identifier Type: -

Identifier Source: org_study_id