Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study

NCT02030340 | Unknown DMC

• 2 other identifiers: AC-WFT-Doc-LLC
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence

Keywords

urodynamic investigation; lower urinary tract dysfunction; catheter; air-charged; water filled

Outcome Measures

Primary Outcomes (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.

  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.

  acute comparison during one test with two types of catheter

Secondary Outcomes (1)

• responses to relevant pressure events: end fill pressure, maximum contraction pressure, maximum pressure at overactive detrusor contraction and maximum cough pressure.

  acute comparison during one test with two types of catheter

Study Arms (1)

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

Interventions

lower urinary tract dysfunction PROCEDURE

Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system

Also known as: T-doc air charged catheters.

Testing Lower urinary tract dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled (on the basis of contemporary clinical standards and protocols) for standard urodynamic investigation.

You may qualify if:

• (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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• UMC Utrecht: lead
• UMCUtrecht, department of Urology: collaborator
• T-Doc-LLC: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

Related Publications (1)

• Rosier PF, Gajewski JB, Sand PK, Szabo L, Capewell A, Hosker GL; International Consultation on Incontinence 2008 Committee on Dynamic Testing. Executive summary: The International Consultation on Incontinence 2008--Committee on: "Dynamic Testing"; for urinary incontinence and for fecal incontinence. Part 1: Innovations in urodynamic techniques and urodynamic testing for signs and symptoms of urinary incontinence in female patients. Neurourol Urodyn. 2010;29(1):140-5. doi: 10.1002/nau.20764.

  PMID: 19693949 BACKGROUND

Study Officials

• Peter FW Rosier, MD PhD

  University Medical Center Utrecht, the Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter FW Rosier, MD PhD

CONTACT

+31887558081; p.f.w.m.rosier@umcutrecht.nl

Ruud JL Bosch, Prof.

CONTACT

+31887558081; J.L.H.R.Bosch@umcutrecht.nl

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer MD PhD

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: January 8, 2014
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

NL (1)