Neurogenic BladderNCT01297647
Incidence of Urinary Tract Infection After Urodynamic Investigation
A study testing urodynamic examination in people with Neurogenic Bladder, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- urodynamic examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation
- No antibiotic treatment
- Written informed consent
Who cannot join
- Pregnancy and breastfeeding
- Current antibiotic therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury
The purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs.
Read the detailed description
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
- Neurogenic Bladder
- Being tested
- urodynamic examination
- Keywords
- urinary tract infection, urodynamics, spinal cord injury
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Tract Infections, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urodynamic examinationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injured | Experimental | Patients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson) Receives: Procedure: urodynamic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary tract infection following urodynamic investigation
every patient receives the urine examination before the urodynamic investigation and hospitalized patients additionally 3 days later and ambulatory patients in case of urinary tract infection
Measured: 3 days after urodynamic investigation
Secondary outcomes (3)
Name and number of identified bacterial species
Measured: 30 minutes before examination
Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract
Measured: 3 days after examination
Incidence of urinary tract infection before urodynamic investigation
every patient receives the urine examination before the urodynamic investigation to detect a potentially urinary tract infection
Measured: 30 minutes before urodynamic investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kessler, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297647
- Sponsor's protocol ID
- EK 2010-0191/0
- Status last verified
- Dec 2016
- First submitted
- 16 Feb 2011
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01297647
- Acronym / sponsor ID
- EK 2010-0191/0
- Conditions
- Neurogenic Bladder
- Keywords
- urinary tract infection, urodynamics, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injured | Experimental | Procedure: urodynamic examinationPatients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation
- No antibiotic treatment
- Written informed consent
Key exclusion criteria (2 listed)
- Pregnancy and breastfeeding
- Current antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urodynamic examinationStandard 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. | Procedure or surgery | Spinal cord injured |
Primary outcome
Incidence of urinary tract infection following urodynamic investigation
Time frame: 3 days after urodynamic investigation
every patient receives the urine examination before the urodynamic investigation and hospitalized patients additionally 3 days later and ambulatory patients in case of urinary tract infection
3 secondary outcomes
Name and number of identified bacterial species
Time frame: 30 minutes before examination
Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract
Time frame: 3 days after examination
Incidence of urinary tract infection before urodynamic investigation
Time frame: 30 minutes before urodynamic investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urodynamic examination in people with Neurogenic Bladder, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary tract infection following urodynamic investigation (time frame: 3 days after urodynamic investigation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.