Trial Comparing Mini-Arc Precise Pro and the Trans Vagina... | NCT01799122

Studies
Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Stress Urinary Incontinence

NCT01799122

Sponsor

University of Manitoba

Status

Unknown status

Last Update Posted

Jan 12, 2016Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Stress Urinary Incontinence
Urethral Sling Surgery

Interventions

Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

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

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Feb 2017Estimated

Completion Date

Not provided

First Submitted Date

Feb 22, 2013

First Submission Date that Met QC Criteria

Feb 22, 2013

First Posted Date

Feb 26, 2013Estimated

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

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Precise sling vs TVT-O sling	Active Comparator		Device: Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)	Device		Precise sling vs TVT-O sling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cough test at one year from surgery		One year

Secondary Outcomes

Measure	Description	Time Frame
Subjective symptoms, QOL questionaires		1 & 2 years post surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with stress urinary incontinence with a positive cough test
patient request surgery for treatment

Exclusion Criteria:

prodominantely overactive bladder
previous failed procedure
MUCP <20 cm H2O
presence of vaginal prolapse > stage 1
voiding dysfunction (PVR>100 mL)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Ken Maslow		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.

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