Clinical trial NCT00676273: TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Official title: TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Lead sponsor: Boston Urogynecology Associates
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Boston Urogynecology Associates
state: Massachusetts
Study officials:
affiliation: Boston Urogynecology Associates
name: Peter Rosenblatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Urogynecology Associates
name: Lekha Hota, MD
role: STUDY_DIRECTOR
References: