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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

Resource links provided by NLM:


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
Active Comparator: 1
TVTO
Device: TVT-Obturator (TVT-O)
sub urethral sling
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on August 26, 2014