Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927548
• Other study ID #: IRB 15 01 06
• Status: Completed
• Phase: N/A
• First received: September 14, 2016
• Last updated: October 6, 2016
• Start date: January 2005
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 29 Years to 89 Years

Eligibility

Inclusion Criteria:

• patient who received the laying of a strip ADVANTAGE between 1/1/2015 and 1/6/2012

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient global improvement scale		6 years	No
Primary	Complications		6 years	No
Primary	Urinary symptom questionnaire		6 years	No