TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Study Details
Study Description
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 in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 TVTO |
Device: TVT-Obturator (TVT-O)
sub urethral sling
|
| Active Comparator: 2 TVTS |
Device: TVT-Secur (TVT-S) (Hammock method)
suburethral sling
|
Outcome Measures
Primary Outcome Measures
- To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test. [1 year]
Secondary Outcome Measures
- To describe or assess known side effects or complications,post-operative pain, time of return to daily activities of living, improvement in patient quality of life, change in Q-tip test [1 year]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Urogynecology Associates | Cambridge | Massachusetts | United States | 02138 |
Sponsors and Collaborators
- Boston Urogynecology Associates
Investigators
- Principal Investigator: Peter Rosenblatt, MD, Boston Urogynecology Associates
- Study Director: Lekha Hota, MD, Boston Urogynecology Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 28142