URINATION DISORDERSTMUCNCT02130843
Tiemann Mounted Urodynamic Catheter Technique for Difficult Bladder Catheterization
An observational study of URINATION DISORDERS, run by Dr. Noam Kitrey at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- URINATION DISORDERS
- What is being tested?
- INSERTION OF URETEHRL CATHETER
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Sep 2013
- Phase
- Observational
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: MALE PATIENTS 18-80 Y/O WHO UNDERWENT URODYNAMIC STUDY, AND HAD DIFFICULT CATHETERIZATION
Who may be able to join
- MEN THAT UNDERWENT URODYNAMIC STUDY EVALUATION BETWEEN 6/2011 TO 9/2013
Who cannot join
- NONE
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RETROSPECTIVE STUDY ABOUT A TECHNIQUE OF INSERTION OF TIEMANN MOUNTED URODYNAMIC CATHETER FOR DIFFICULT BLADDER CATHETERIZATION IN MALES
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.
Read the 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.
- Conditions
- URINATION DISORDERS
- Being tested
- INSERTION OF URETEHRL CATHETER
- Keywords
- URINARY INCONTINENCE, URODYNAMICS, URINARY RETENTION, URINARY CATHETERIZATION
- Medical subject headings
- Urination Disorders, Urinary Incontinence, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSERTION OF URETEHRL CATHETERDevice
Also called TIEMANN CATHETER
USE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER
| Study group | Role | What they receive |
|---|---|---|
| MALE PATIENTS BEFORE UDS | MALE PATIENTS BEFORE UDS WITH DIFFICULT CATHETERIZATION Receives: Device: INSERTION OF URETEHRL CATHETER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Catheterization
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startJun 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for URINATION DISORDERSStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Noam Kitrey
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Noam Kitrey, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130843
- Sponsor's protocol ID
- SMC-13-0717
- Acronym
- TMUC
- Status last verified
- May 2014
- First submitted
- 1 May 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETROSPECTIVE STUDY ABOUT A TECHNIQUE OF INSERTION OF TIEMANN MOUNTED URODYNAMIC CATHETER FOR DIFFICULT BLADDER CATHETERIZATION IN MALES
- ClinicalTrials.gov ID
- NCT02130843
- Acronym / sponsor ID
- TMUC / SMC-13-0717
- Conditions
- URINATION DISORDERS
- Keywords
- URINARY INCONTINENCE, URODYNAMICS, URINARY RETENTION, URINARY CATHETERIZATION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Noam KitreyOther government
- Study start
- Jun 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 May 2014 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MALE PATIENTS BEFORE UDS | – | Device: INSERTION OF URETEHRL CATHETERMALE PATIENTS BEFORE UDS WITH DIFFICULT CATHETERIZATION |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MALE PATIENTS 18-80 Y/O WHO UNDERWENT URODYNAMIC STUDY, AND HAD DIFFICULT CATHETERIZATION
Key inclusion criteria (1 listed)
- MEN THAT UNDERWENT URODYNAMIC STUDY EVALUATION BETWEEN 6/2011 TO 9/2013
Key exclusion criteria (2 listed)
- NONE
- -
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 |
|---|---|---|
| INSERTION OF URETEHRL CATHETERAlso: TIEMANN CATHETERUSE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER | Device | MALE PATIENTS BEFORE UDS |
Primary outcome
Successful Catheterization
Time frame: Immediate
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 5 May 2014.
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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?
An observational study of URINATION DISORDERS, run by Dr. Noam Kitrey at 1 site in Israel.
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 1 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 5 May 2014. 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 Israel. 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?
Successful Catheterization (time frame: Immediate). 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 5 May 2014.