Recruiting

TVT-Secur vs. TVT-Obturator

Sponsor:

Boston Urogynecology Associates

Code:

NCT00676273

Conditions

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

TVT-Obturator (TVT-O)

TVT-Secur (TVT-S) (Hammock method)

Study Details

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.

Conditions

Stress Urinary Incontinence

Study ID

NCT00676273

Start date

Mar, 2007

Status verified date

May, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Mar, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

TVTO

active comparator: 2

TVTS

Interventions

TVT-Obturator (TVT-O)

sub urethral sling

TVT-Secur (TVT-S) (Hammock method)

suburethral sling

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 ]

Central Contacts and Locations

Locations

Boston Urogynecology Associates

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Lekha Hota, MD

617-354-5452

Principal Investigator:

Peter Rosenblatt, MD

More Information

Sponsor

Boston Urogynecology Associates

Last update posted

May 13, 2008

Last verified

May, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Urogynecology Associates on 2008-05-13.