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

Incontinence Clinical Trial

— ACWF  

Official title:

In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02030340
• Other study ID #: AC-WF
• Secondary ID: T-Doc-LLC
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2013
• Last updated: January 6, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: UMC Utrecht
• Contact: Peter FW Rosier, MD PhD
• Phone: +31887558081
• Email: p.f.w.m.rosier[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

N/A

Related Conditions & MeSH terms

• Incontinence

Intervention

Procedure:
• lower urinary tract dysfunction
Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	T-Doc-LLC, UMCUtrecht, department of Urology

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Rosier PF, Gajewski JB, Sand PK, Szabó 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	responses to relevant pressure events: end fill pressure, maximum contraction pressure, maximum pressure at overactive detrusor contraction and maximum cough pressure.	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.	acute comparison during one test with two types of catheter	No