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Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.

NCT02981654 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-12-06

No results posted yet for this study

Summary

This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).

Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.

Conditions

  • Female Stress Urinary Incontinence

Interventions

DEVICE

Alma Lasers Pixel carbon dioxide laser system

The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.

Sponsors & Collaborators

  • The Baruch Padeh Medical Center, Poriya

    collaborator OTHER_GOV

  • Kaplan Medical Center

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Menachem Alcalay, MD · Head, Urogynecology Unit, Chaim Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-05-31
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981654 on ClinicalTrials.gov