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

Female Stress Urinary Incontinence Clinical Trial

Official title: Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Improvement in SUI symptoms as measured by the following parameters:

Objective parameters:

• Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:

• Number of incontinence episodes per day

• Number of pads used per day

• Change from baseline in 1 hour pad test 1, 2, 6 and 12 months

• Change from baseline as assessed with Vaginal Biopsy

Subjective parameters:

• Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1, 2, 6 and 12 months

• Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2, 6 and 12 months

• Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) - at 1, 2, 6 and 12 months

• Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12 months ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

• NCT number: NCT02981654
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Yair Leopld
• Phone: 972-54-4847271
• Email: Yair.Leopold@almasurgical.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2016
• Completion date: May 2018