Status:
UNKNOWN
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Lead Sponsor:
Boston Urogynecology Associates
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 i...
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-operati...
Eligibility Criteria
Inclusion
- Are at least 18 years of age
- Demonstrate a positive cough stress test during complex multi-channel urodynamic testing
- Demonstrate impact of stress urinary incontinence on quality of life questionnaire
- Are able to comprehend and sign a written informed consent
- Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations
- Are psychologically stable and suitable for interventions determined by the investigator
- Are ambulatory and able to use a toilet independently
Exclusion
- Patients:
- Who are pregnant or planning to become pregnant during the study or in the future
- With a elevated post-void residual (defined as PVR \> 100cc)
- With a bleeding condition or on anti-coagulant therapy
- With immunosuppression (i.e. HIV, lymphoma)
- With multiple sclerosis or other progressive neurological disease
- With evidence of a local or systemic infection, including urinary tract infection
- With evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of \<20 cm H2O
- Previous sub-urethral sling
- Predominant overactive bladder symptoms
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00676273
Start Date
March 1 2007
End Date
December 1 2009
Last Update
May 13 2008
Active Locations (1)
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1
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138