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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00676273
Recruitment Status : Unknown
Verified May 2008 by Boston Urogynecology Associates.
Recruitment status was:  Recruiting
First Posted : May 13, 2008
Last Update Posted : May 13, 2008
Information provided by:
Boston Urogynecology Associates

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
Stress Urinary Incontinence Device: TVT-Obturator (TVT-O) Device: TVT-Secur (TVT-S) (Hammock method) 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Study Start Date : March 2007
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Device: TVT-Obturator (TVT-O)
sub urethral sling

Active Comparator: 2
Device: TVT-Secur (TVT-S) (Hammock method)
suburethral sling

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00676273

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

Responsible Party: Peter Rosenblatt, MD, Boston Urogynecology Associates Identifier: NCT00676273     History of Changes
Other Study ID Numbers: 28142
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: May 13, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders