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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Boston Urogynecology Associates.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Boston Urogynecology Associates
ClinicalTrials.gov Identifier:
NCT00676273
First received: November 16, 2007
Last updated: May 12, 2008
Last verified: May 2008

November 16, 2007
May 12, 2008
March 2007
March 2009   (final data collection date for primary outcome 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00676273 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stress Urinary Incontinence
  • Device: TVT-Obturator (TVT-O)
    sub urethral sling
  • Device: TVT-Secur (TVT-S) (Hammock method)
    suburethral sling
  • Active Comparator: 1
    TVTO
    Intervention: Device: TVT-Obturator (TVT-O)
  • Active Comparator: 2
    TVTS
    Intervention: Device: TVT-Secur (TVT-S) (Hammock method)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2009
March 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
United States
 
NCT00676273
28142
No
Peter Rosenblatt, MD, Boston Urogynecology Associates
Boston Urogynecology Associates
Not Provided
Principal Investigator: Peter Rosenblatt, MD Boston Urogynecology Associates
Study Director: Lekha Hota, MD Boston Urogynecology Associates
Boston Urogynecology Associates
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP