TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Status unconfirmed · Phase 4
Conditions studied: Stress Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT00676273
- Run by
- Boston Urogynecology Associates
- People needed
- 140
- Starts
- 2007-03-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2008-05-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Boston Urogynecology Associates — Cambridge, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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