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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: TVT-Obturator (TVT-O); Device: TVT-Secur (TVT-S) (Hammock method)

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
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Recruiting
      • Boston Urogynecology Associates
      • Contact: Lekha Hota, MD; Phone Number: 617-354-5452
      • Sub-Investigator: Lekha Hota, MD
      • Sub-Investigator: Eman Elkadry, MD
      • Sub-Investigator: Anthony Disciullo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Boston Urogynecology Associates
• Investigators: Principal Investigator: Peter Rosenblatt, MD, Boston Urogynecology Associates; Study Director: Lekha Hota, MD, Boston Urogynecology Associates

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ANTICIPATED): March 1, 2009
• Study Completion (ANTICIPATED): December 1, 2009

Study Registration Dates

• First Submitted: November 16, 2007
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (ESTIMATE): May 13, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2008
• Last Update Submitted That Met QC Criteria: May 12, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 28142