TVT-Secur Versus TVT-Obturator: A Randomized Trial of Sub... | NCT00676273

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

NCT00676273

Sponsor

Boston Urogynecology Associates

Status

Unknown status

Last Update Posted

May 13, 2008Estimated

Enrollment

140Estimated

Phase

Phase 4

Conditions

Stress Urinary Incontinence

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

May 12, 2008

First Posted Date

May 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2008

Last Update Posted Date

May 13, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	TVTO	Device: TVT-Obturator (TVT-O)
2	Active Comparator	TVTS	Device: TVT-Secur (TVT-S) (Hammock method)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TVT-Obturator (TVT-O)	Device	sub urethral sling	1
TVT-Secur (TVT-S) (Hammock method)

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Rosenblatt, MD	Boston Urogynecology Associates	Principal Investigator
Lekha Hota, MD	Boston Urogynecology Associates	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Urogynecology Associates	Recruiting	Cambridge	Massachusetts	02138	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37888839	Derived	Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

Type	Date	Date Unknown
Release	Jul 25, 2013
Reset	Sep 24, 2013

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases