Patient-reported Outcome After Sling Insertion Using the... | NCT01042275

Studies
Patient-reported Outcome After Sling Insertion Using the Incontinence Outcome Questionnaire (IOQ)

NCT01042275

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jan 7, 2020Actual

Enrollment

628Actual

Phase

Not provided

Conditions

Stress Urinary Incontinence

Interventions

Not provided

Countries

Switzerland

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

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 4, 2010

First Posted Date

Jan 5, 2010Estimated

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 6, 2020

Last Update Posted Date

Jan 7, 2020Actual

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

Midurethral tapes are by now standard procedure in the surgical treatment of women with stress urinary incontinence. While the retropubic TVT is well documented with long-term results up to 11 years and continence rates of 90 %, the published data for the transoburator tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was constructed to assess patient-reported outcome and quality of life after insertion of a midurethral tape and validated for the German language. The aim of this study was to evaluate patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape, inside-out (TVT-O).

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

628Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TOT		transobturator sling, outside-in (TOT)
TVT-O		Tension-free transobturator tape, inside-out (TVT-O)
IVS		retropubic Intravaginal Sling (IVS)
TVT		retropubic tension-free vaginal tape (TVT)
REMEEX		Re-adjustable mechanical external sling (REMEEX)

Interventions

Not provided

Measure	Description	Time Frame
patient's satisfaction		3/2009

Measure	Description	Time Frame
re-admission		3/2009

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

incontinence sling
time frame 1/1999 - 12/2007

Accepts Healthy Volunteers

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

patients who were treated at 2 Swiss public teaching hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cornelia Betschart, MD	Clinic for Gynecology, University Hospital of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Hospital, Clinic for Gynecology		Zurich		8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided