Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study (ACWF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02030340
Recruitment Status : Unknown
Verified January 2014 by Peter F.W.M. Rosier, UMC Utrecht.
Recruitment status was:  Recruiting
First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Collaborators:
UMCUtrecht, department of Urology
T-Doc-LLC
Information provided by (Responsible Party):
Peter F.W.M. Rosier, UMC Utrecht

Brief Summary:

Various systems to measure intravesical and intrarectal pressure during urodynamic testing; especially cystometry, exist. Water filled tube -systems are the most commonly used and should be regarded as the contemporary standard. A water filled system is however sensitive to tube and or patient movement artefacts and prone to erroneous calibration. Air charged catheters are less sensitive to patient and especially tubing- movements, and calibrate easier. However, in vitro tests have demonstrated that air charged catheters respond somewhat slower and relatively damped, especially to rapid pressure changes as in (simulated) coughing, in comparison with water filled systems. The clinical relevance of these observations is unknown.

This is a study to compare the technical reliability and clinical applicability of the two types of catheter systems for cystometry in a synchronous double catheter testing procedure in a prospective group or patients scheduled for urodynamic investigation.


Condition or disease Intervention/treatment
Incontinence Procedure: lower urinary tract dysfunction

Detailed Description:

Study design: Patient cohort, acute experiment, mono -center synchronous double urodynamic catheter technique study.

Study population: Adult female patients and male or female patients with spinal cord injury or meningomyelocele unable to void, scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and or symptoms of lower urinary tract dysfunction.

Intervention: Synchronous double catheter urodynamic testing; Standard filling cystometry with both air-charged ánd water filled catheter pairwise inserted, and connected to the registry equipment.

Main study parameters/endpoints: Difference of intravesical pressure increment maximum during filling cystometry between the two systems.

Primary hypothesis to test: The average difference as well as the average absolute difference of maximum water pressure (standard system) and maximum air pressure (comparator) are both 0 (zero).

There is no per-protocol for follow up of the patients.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 36 participants
Official Title: In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study
Study Start Date : December 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Group/Cohort Intervention/treatment
Testing Lower urinary tract dysfunction
All patients with lower urinary tract dysfunction where urodynamic diagnosis is required according to standards and (international) practice guidelines will have a synchronous double system (combination of air-charged and water filled) urodynamic test.
Procedure: lower urinary tract dysfunction
Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system
Other Name: T-doc air charged catheters.




Primary Outcome Measures :
  1. The difference between the water filled catheter recorded and simultaneously air charged catheter recorded maximum pressure (amplitude)during the bladder filling phase of urodynamic test. [ Time Frame: acute comparison during one test with two types of catheter ]
    Null hypothesis: the (absolute mean) difference between the water filled catheter recorded and simultaneously air charged catheter recorded maximum pressure (amplitude) observed with a dominant detrusor pressure event during urodynamic filling as obtained with both systems is close to zero.


Secondary Outcome Measures :
  1. responses to relevant pressure events: end fill pressure, maximum contraction pressure, maximum pressure at overactive detrusor contraction and maximum cough pressure. [ Time Frame: acute comparison during one test with two types of catheter ]
    to test the clinical feasibility (-mean absolute- pressure responses differences) of the air charged system, against the contemporary clinical standard. Perfect feasibility of air charged catheter system is achieved when the measured pressures are equal (difference zero) to the water filled system in all performed measurements in all situations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled (on the basis of contemporary clinical standards and protocols) for standard urodynamic investigation.
Criteria

Inclusion Criteria:

(All necessary:)

  • Female gt18 years
  • Scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and symptoms of lower urinary tract dysfunction.
  • May perform (not excluded) intermittent (self) catheterisation.
  • No signs of voiding dysfunction (routine outpatient max flow above 20 millilitre per second without postvoid residual)
  • No signs of bladder /pelvic pain syndrome

OR:

(All necessary)

  • Male or female gt18years
  • Complete spinal cord injury, level above T12, or meningomyelocele unable to void and significantly reduced or no pelvic floor, urethral or bladder sensation.
  • May have (not excluded) 'sacral sparing'; some residual anal sensation
  • Scheduled for urodynamic investigation on the basis of contemporary standards and guidelines, because of signs and symptoms of lower urinary tract dysfunction or because of routine (protocol, guidelines) follow -up.
  • Usually: performing intermittent (self) catheterisation); not excluded.
  • May have (not excluded) indwelling catheter.

Exclusion Criteria:

  • Unwilling or unfit to sign informed consent.
  • American Society of Anesthesiologists -score gt2; karnovsky lt80percent.
  • Male with normal lower urinary tract sensation.
  • Women with signs of voiding dysfunction.
  • Patients included in scientific studies (for other reasons).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030340


Contacts
Layout table for location contacts
Contact: Peter FW Rosier, MD PhD +31887558081 p.f.w.m.rosier@umcutrecht.nl
Contact: Ruud JL Bosch, Prof. +31887558081 J.L.H.R.Bosch@umcutrecht.nl

Locations
Layout table for location information
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Principal Investigator: Peter FW Rosier, MD PhD         
Sponsors and Collaborators
UMC Utrecht
UMCUtrecht, department of Urology
T-Doc-LLC
Investigators
Layout table for investigator information
Principal Investigator: Peter FW Rosier, MD PhD University Medical Center Utrecht, the Netherlands
Publications:
Layout table for additonal information
Responsible Party: Peter F.W.M. Rosier, Senior Lecturer MD PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02030340    
Other Study ID Numbers: AC-WF
T-Doc-LLC ( Other Grant/Funding Number: T-Doc-LLC Wilmington USA )
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014
Keywords provided by Peter F.W.M. Rosier, UMC Utrecht:
urodynamic investigation
lower urinary tract dysfunction
catheter
air-charged
water filled