A Comparative Study Minisling Versus Transobturator (TOT)Sling

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01094353
• Date of registration: 24/03/2010
• Primary sponsor: Federal University of São Paulo
• Public title: A Comparative Study Minisling Versus Transobturator (TOT)Sling sui
• Scientific title: Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
• Date of first enrolment: June 2008
• Target sample size: 50
• Recruitment status: Enrolling by invitation
• URL: http://clinicaltrials.gov/show/NCT01094353
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Brazil

Contacts

• Name: Lucyana m djehdian, Pg
• Affiliation: Federal University of São Paulo

Key inclusion & exclusion criteria

Inclusion Criteria:

- clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years

Exclusion Criteria:

- postvoid residual urine volume more than 100 ml, coagulation disorders, current
urinary tract infection, sequelae of previous radiation therapy of the pelvis,
anticoagulant therapy, vulvovaginitis, and anesthesia contraindication



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Female Stress Urinary Incontinence

Intervention(s)

Procedure: minisling ophira™

Primary Outcome(s)

to assess efficacy between tot with minisling in cure in women with stress urinary incontinence [Time Frame: one year]

Secondary ID(s)

ophira

Source(s) of Monetary Support

Please refer to primary and secondary sponsors