MedDataX Logo

Incidence of Urinary Tract Infection After Urodynamic Investigation

NCT ID: NCT01297647

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with neurogenic bladder dysfunction after spinal cord injury need lifelong urologic control examinations with CMG (urodynamic examination). The manipulation may cause urinary tract infections which have to be treated. Patients often noticed an infection after a CMG examination. Aim of this study is the determination of the infection rate and germs. Also should be noticed the pre-interventional infections and differences between the causing germs. Simultaneously the investigators test the reliability of the quicktest for urinary infection. Additionally the investigators will examine the Quality of Life in patients with neurogenic bladder dysfunction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurogenic Bladder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

urinary tract infection urodynamics spinal cord injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal cord injured

Patients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson)

Group Type EXPERIMENTAL

urodynamic examination

Intervention Type PROCEDURE

Standard urodynamic investigation according to the ICS standard, Good urodynamic practice.Following insertion of 8 F transurethral catheter, retrograde filling of the bladder (20 mL/min) with body warm saline.

Current recording of pabd. , pves and pdet., subsequently pressure flow study. Additionally imaging with fluoroscopy to detect possible vesico ureteral renal reflux.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

urodynamic examination

Standard urodynamic investigation according to the ICS standard, Good urodynamic practice.Following insertion of 8 F transurethral catheter, retrograde filling of the bladder (20 mL/min) with body warm saline.

Current recording of pabd. , pves and pdet., subsequently pressure flow study. Additionally imaging with fluoroscopy to detect possible vesico ureteral renal reflux.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation
* No antibiotic treatment
* Written informed consent

Exclusion Criteria

* Pregnancy and breastfeeding
* Current antibiotic therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Balgrist University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Kessler

Executive physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EK 2010-0191/0

Identifier Type: -

Identifier Source: org_study_id