Tiemann Mounted Urodynamic Catheter Technique for Difficu... | NCT02130843

Studies
Tiemann Mounted Urodynamic Catheter Technique for Difficult Bladder Catheterization

NCT02130843

Sponsor

Dr. Noam Kitrey

Status

Completed

Last Update Posted

May 5, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

URINATION DISORDERS

Interventions

INSERTION OF URETEHRL CATHETER

Countries

Israel

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

May 2014

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

Jun 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 2, 2014

First Posted Date

May 5, 2014Estimated

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 2, 2014

Last Update Posted Date

May 5, 2014Estimated

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

A report of a technique for insertion a soft urodynamic catheter into the bladder, when urethral obstruction causes the catheter to bend and fold over itself at the resistance site.

Detailed Description

The urodynamic catheter is mounted on a 12F Coudé tip Tiemann catheter, which then carries the tip of the urodynamic catheter beyond the obstruction site into the bladder.

The Tiemann catheter-mounted urodynamic catheter technique can serve as a suitable option to insert a urodynamic catheter into the bladder in all male patients in whom it fails due to kinking.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MALE PATIENTS BEFORE UDS		MALE PATIENTS BEFORE UDS WITH DIFFICULT CATHETERIZATION	Device: INSERTION OF URETEHRL CATHETER

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INSERTION OF URETEHRL CATHETER	Device	USE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER	MALE PATIENTS BEFORE UDS

Measure	Description	Time Frame
Successful Catheterization		Immediate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- MEN THAT UNDERWENT URODYNAMIC STUDY EVALUATION BETWEEN 6/2011 TO 9/2013

Exclusion Criteria:

NONE

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

MALE PATIENTS 18-80 Y/O WHO UNDERWENT URODYNAMIC STUDY, AND HAD DIFFICULT CATHETERIZATION

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan	IL	5265601	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014555	Urination Disorders
D014549	Urinary Incontinence
D016055	Urinary Retention

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided