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

Sponsored by:	Boston Urogynecology Associates
Information provided by:	Boston Urogynecology Associates
ClinicalTrials.gov Identifier:	NCT00676273

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.

Condition	Intervention	Phase
Stress Urinary Incontinence	Device: TVT-Obturator (TVT-O) Device: TVT-Secur (TVT-S) (Hammock method)	Phase IV

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

Further study details as provided by Boston Urogynecology Associates:

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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator TVTO	Device: TVT-Obturator (TVT-O) sub urethral sling
2: Active Comparator TVTS	Device: TVT-Secur (TVT-S) (Hammock method) suburethral sling

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676273

Locations

United States, Massachusetts
Boston Urogynecology Associates	Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Lekha Hota, MD 617-354-5452
Principal Investigator: Peter Rosenblatt, MD
Sub-Investigator: Lekha Hota, MD
Sub-Investigator: Eman Elkadry, MD
Sub-Investigator: Anthony Disciullo, MD

Sponsors and Collaborators

Boston Urogynecology Associates

Investigators

Principal Investigator:	Peter Rosenblatt, MD	Boston Urogynecology Associates
Study Director:	Lekha Hota, MD	Boston Urogynecology Associates

More Information

Responsible Party:	Boston Urogynecology Associates ( Peter Rosenblatt, MD )
Study ID Numbers:	28142
Study First Received:	November 16, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00676273
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009