Expired Study
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Cambridge, Massachusetts 02138


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Criteria: 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


NCT ID:

NCT00676273


Primary Contact:

Principal Investigator
Peter Rosenblatt, MD
Boston Urogynecology Associates


Backup Contact:

N/A


Location Contact:

Cambridge, Massachusetts 02138
United States

Lekha Hota, MD
Phone: 617-354-5452

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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