NCT00676273

TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Boston Urogynecology Associates · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.

Detailed description

Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	TVT-Obturator (TVT-O)	sub urethral sling
DEVICE	TVT-Secur (TVT-S) (Hammock method)	suburethral sling

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-03-01
• Completion: 2009-12-01
• First posted: 2008-05-13
• Last updated: 2008-05-13

Locations

1 site across 1 country: United States