Trial Comparing TVT SECUR System and Trans Vaginal Obtura... | NCT00527696

Studies
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

NCT00527696

Sponsor

University of Manitoba

Status

Terminated

Last Update Posted

Jan 12, 2016Estimated

Enrollment

106Actual

Phase

Phase 3

Conditions

Stress Urinary Incontinence

Interventions

transvaginal obturator tape

Countries

Canada

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

statistical Significance was reached for primary outcome

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Sep 10, 2007

First Submission Date that Met QC Criteria

Sep 10, 2007

First Posted Date

Sep 11, 2007Estimated

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

Jan 8, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TVT SECURE	Active Comparator	sling	Procedure: transvaginal obturator tape
TVT O	Active Comparator	sling	Procedure: transvaginal obturator tape

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transvaginal obturator tape	Procedure		TVT O TVT SECURE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective cure as defined by the cough test at one year from surgery		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.

Exclusion Criteria:

Women with predominantly symptoms of urge urinary incontinence
Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
Detrusor overactivity on cystometrogram at urodynamic testing
Previous surgery for incontinence
Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o)
Voiding dysfunction with postvoid residual >100 cc

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ken D Maslow, MD	St. Boniface Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Boniface Hospital		Winnipeg	Manitoba	R2H 2A6	Canada

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.
24452619	Derived	Maslow K, Gupta C, Klippenstein P, Girouard L. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. Int Urogynecol J. 2014 Jul;25(7):909-14. doi: 10.1007/s00192-013-2312-7. Epub 2014 Jan 23.

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