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Completed

NCT Number: NCT02861391

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CO2 AcuPulse Laser

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

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.

Primary outcomes

  1. Pad weight test.

    Time frame: 15 months from recruitment.

    Pad weight results in grams.

Secondary outcomes

  1. Urinary distress index 6 questionnaire.

    Time frame: 15 months from recruitment.

    Total questionnaire score.

  2. Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.

    Time frame: 15 months from recruitment.

    Total questionnaire score.

  3. International Consultation of Incontinence questionnaire.

    Time frame: 15 months from recruitment.

    Total questionnaire score.

  4. Cough test

    Time frame: 15 months from recruitment.

    cough test results.

  5. Visual analogue scale.

    Time frame: 15 months from recruitment.

    Pain rated with the visual analogue score.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 10, 2016
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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