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

Rambam Health Care Campus

Status: Completed

Conditions: Exposure Laser

Treatments: Device: CO2 AcuPulse Laser; Device: Sham Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02861391

0205-16-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

CO2 AcuPulse Laser treatment

Experimental group

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.

Treatment:

Device: CO2 AcuPulse Laser

Sham laser treatment

Sham Comparator group

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.

Treatment:

Device: Sham Laser