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

Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02861391

Enrollment

125

Registered

2016-08-10

Start date

2019-10-04

Completion date

2022-01-30

Last updated

2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure Laser

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.

Interventions

DEVICECO2 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.

DEVICESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Pad weight test.	15 months from recruitment.	Pad weight results in grams.

Secondary

Measure	Time frame	Description
Urinary distress index 6 questionnaire.	15 months from recruitment.	Total questionnaire score.
Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.	15 months from recruitment.	Total questionnaire score.
International Consultation of Incontinence questionnaire.	15 months from recruitment.	Total questionnaire score.
Cough test	15 months from recruitment.	cough test results.
Visual analogue scale.	15 months from recruitment.	Pain rated with the visual analogue score.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026