IncontinenceACWFNCT02030340
Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study
An observational study of Incontinence, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence
- What is being tested?
- lower urinary tract dysfunction
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2013to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled (on the basis of contemporary clinical standards and protocols) for standard urodynamic investigation.
Who may be able to join
- (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
Show all 14Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584CX
Peter FW Rosier, MD PhD
About this study
Official title: In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study
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.
Read the 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
- Being tested
- lower urinary tract dysfunction
- Keywords
- urodynamic investigation, lower urinary tract dysfunction, catheter, air-charged, water filled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower urinary tract dysfunctionProcedure or surgery
Also called T-doc air charged catheters.
Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: lower urinary tract dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: acute comparison during one test with two types of catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- UMCUtrecht, department of Urology, T-Doc-LLC
- Responsible party
- Principal investigator, Peter F.W.M. Rosier, UMC Utrecht
- Investigators
- Peter FW Rosier, MD PhD, Principal investigator, University Medical Center Utrecht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030340
- Sponsor's protocol ID
- AC-WF
- Other IDs
- T-Doc-LLC
- Acronym
- ACWF
- Status last verified
- Jan 2014
- First submitted
- 6 Mar 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19693949
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Comparison of Air Charged Catheters With Water Filled Catheters for Intravesical and Intrarectal Pressures Recording During Urodynamic Study
- ClinicalTrials.gov ID
- NCT02030340
- Acronym / sponsor ID
- ACWF / AC-WF
- Conditions
- Incontinence
- Keywords
- urodynamic investigation, lower urinary tract dysfunction, catheter, air-charged, water filled
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- UMCUtrecht, department of Urology, T-Doc-LLC
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Jan 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.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing Lower urinary tract dysfunction | – | Procedure: lower urinary tract dysfunctionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled (on the basis of contemporary clinical standards and protocols) for standard urodynamic investigation.
Key inclusion criteria (14 listed)
- (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)
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| lower urinary tract dysfunctionAlso: T-doc air charged catheters.Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system | Procedure or surgery | Testing Lower urinary tract dysfunction |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Background: PubMed 19693949Rosier 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.
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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.
Peter FW Rosier, MD PhD principal investigator
University Medical Center Utrecht, the Netherlands
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 Incontinence, run by UMC Utrecht at 1 site in Netherlands.
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 14 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jan 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter FW Rosier, MD PhD (+31887558081, p.f.w.m.rosier@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030340, which also lists 1 linked publication.
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 8 Jan 2014.