NCT02130843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

May 1, 2014

Last Update Submit

May 2, 2014

Conditions

URINATION DISORDERS

Keywords

URINARY INCONTINENCEURODYNAMICSURINARY RETENTIONURINARY CATHETERIZATION

Outcome Measures

Primary Outcomes (1)

  • Successful Catheterization

    Immediate

Study Arms (1)

MALE PATIENTS BEFORE UDS

MALE PATIENTS BEFORE UDS WITH DIFFICULT CATHETERIZATION

Device: INSERTION OF URETEHRL CATHETER

Interventions

INSERTION OF URETEHRL CATHETERDEVICE

USE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER

Also known as: TIEMANN CATHETER
MALE PATIENTS BEFORE UDS

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, IL, 5265601, Israel

Location

MeSH Terms

Conditions

Urination DisordersUrinary IncontinenceUrinary Retention

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Urologist, Department of Urology

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 5, 2014

Study Start

June 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

IL(1)