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NCT Number: NCT05097456

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 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. 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

carbon dioxide laser

Device

carbon dioxide laser

sham laser

Device

sham laser

Primary outcomes

  1. Pad weight test

    Time frame: From treatment up to 12 months post treatment

    Change in pad weight

Secondary outcomes

  1. Cough test

    Time frame: From treatment up to 12 months post treatment

    Positive cough test

  2. Urinary distress index questionnaire

    Time frame: From treatment up to 12 months post treatment

    Change in urinary distress index questionnaire scores

  3. International consultation on incontinence questionnaire-urinary incontinence

    Time frame: From treatment up to 12 months post treatment

    Change in international consultation on incontinence questionnaire-urinary incontinence scores

  4. Pelvic organ prolapse/urinary incontinence sexual questionnaire

    Time frame: From treatment up to 12 months post treatment

    Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2021
Registry last updated
Feb 7, 2022

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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