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

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TVT-Obturator (TVT-O)
TVT-Secur (TVT-S) (Hammock method)
Sponsored by
Boston Urogynecology Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Urogynecology AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

TVTO

TVTS

Outcomes

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.

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

Full Information

First Posted
November 16, 2007
Last Updated
May 12, 2008
Sponsor
Boston Urogynecology Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00676273
Brief Title
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Official Title
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Urogynecology Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
TVTO
Arm Title
2
Arm Type
Active Comparator
Arm Description
TVTS
Intervention Type
Device
Intervention Name(s)
TVT-Obturator (TVT-O)
Intervention Description
sub urethral sling
Intervention Type
Device
Intervention Name(s)
TVT-Secur (TVT-S) (Hammock method)
Intervention Description
suburethral sling
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rosenblatt, MD
Organizational Affiliation
Boston Urogynecology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lekha Hota, MD
Organizational Affiliation
Boston Urogynecology Associates
Official's Role
Study Director
Facility Information:
Facility Name
Boston Urogynecology Associates
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lekha Hota, MD
Phone
617-354-5452
First Name & Middle Initial & Last Name & Degree
Peter Rosenblatt, MD
First Name & Middle Initial & Last Name & Degree
Lekha Hota, MD
First Name & Middle Initial & Last Name & Degree
Eman Elkadry, MD
First Name & Middle Initial & Last Name & Degree
Anthony Disciullo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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