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

NCT ID: NCT02030340

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Incontinence

Study Groups

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.

lower urinary tract dysfunction

Intervention Type: PROCEDURE

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

Interventions

lower urinary tract dysfunction

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

Intervention Type: PROCEDURE

Other Intervention Names

T-doc air charged catheters.

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMCUtrecht, department of Urology

UNKNOWN

Sponsor Role: collaborator

T-Doc-LLC

UNKNOWN

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Peter F.W.M. Rosier

Senior Lecturer MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter FW Rosier, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht, the Netherlands

Locations

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Peter FW Rosier, MD PhD

Role: CONTACT

p.f.w.m.rosier@umcutrecht.nl

+31887558081

Ruud JL Bosch, Prof.

Role: CONTACT

J.L.H.R.Bosch@umcutrecht.nl

+31887558081

References

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.

Reference Type: BACKGROUND

PMID: 19693949 (View on PubMed)

Other Identifiers

T-Doc-LLC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AC-WF

Identifier Type: -

Identifier Source: org_study_id