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

Boston Urogynecology Associates

Status and phase

Unknown

Phase 4

Conditions

Stress Urinary Incontinence

Treatments

Device: TVT-Obturator (TVT-O)

Device: TVT-Secur (TVT-S) (Hammock method)

Study type

Interventional

Funder types

Other

Identifiers

NCT00676273

28142

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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