UrodynamicsNCT02756182
Air-charged vs Water-filled Catheters (Bonn)
A study testing TDOC air-charged catheter in people with Urodynamics, run by Laborie Medical Technologies Inc. at 1 site in Germany.
Trial summary
A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Urodynamics
- What is being tested?
- TDOC air-charged catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2016to 22 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients normally indicated for urodynamic evaluations
Who cannot join
- Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
- Patients who suffer from strictures in the urethra
- Patients who are pregnant
- Patients who require the use of a suprapubic catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Air-filled and Water-filled Catheters for Use in Cystometric Assessment
A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at various fill volumes for the bladder.
Read the detailed description
The objective of this study was to compare the use of water-filled and air-charged catheters in determining equivalency between the two technologies during cystometric assessment.
A total of 25 patients (9M/16F) were recruited. All patients underwent cough and Valsalva manoeuvre pressure tests to measure vesicle pressure (Pves) and abdominal pressure (Pabd). A single dual-lumen catheter (T-DOC 7Fr Air-Charged® catheter) was used to record air and water pressures simultaneously.
The primary outcome was to determine if the maximum pressures during Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 200 cc during a urodynamic evaluation.
Exploratory endpoints included the following:
- To determine if maximum pressures for cough, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100, 200 and Maximum Bladder Capacity (MBC) cc during a urodynamic evaluation.
- To determine if maximum pressures for Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100 and MBC cc during a urodynamic evaluation (as well as 200 cc which is the primary objective).
- To determine if the maximum voiding pressure, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent.
- To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters.
- To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters.
- Conditions
- Urodynamics
- Being tested
- TDOC air-charged catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDOC air-charged catheterDevice
Urodynamic study utilizing a single catheter technique to measure WP \& AC measurements
| Study group | Role | What they receive |
|---|---|---|
| Urodynamics with AC and WP | Experimental | Patients underwent a conventional urodynamics study utilizing a single catheter technique Receives: Device: TDOC air-charged catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Vesical Pressure During Valsalva Manoeuvres
Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Measured: Measured during a single urodynamic evaluation
Maximum Abdominal Pressure During Valsalva Manoeuvres
Maximum abdominal pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Measured: Measured during a single urodynamic evaluation
Maximum Detrusor Pressure at Valsalva Manoeuvres
Maximum detrusor pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Measured: Measured during a single urodynamic evaluation
Secondary outcomes (3)
Maximum Vesical Pressure During Coughs
Maximum vesical pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Measured: Measured during a single urodynamic evaluation
Maximum Abdominal Pressure During Coughs
Maximum abdominal pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Measured: Measured during a single urodynamic evaluation
Maximum Detrusor Pressure During Coughs
Maximum detrusor pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Measured: Measured during a single urodynamic evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start27 Apr 2016
- Primary completion22 Aug 2016
- Study completion22 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UrodynamicsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laborie Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756182
- Sponsor's protocol ID
- AvW-Bonn-01
- Status last verified
- Jan 2020
- First submitted
- 19 Apr 2016
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Air-filled and Water-filled Catheters for Use in Cystometric Assessment
- ClinicalTrials.gov ID
- NCT02756182
- Acronym / sponsor ID
- AvW-Bonn-01
- Conditions
- Urodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Laborie Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at various fill volumes for the bladder.
Detailed description
The objective of this study was to compare the use of water-filled and air-charged catheters in determining equivalency between the two technologies during cystometric assessment.
A total of 25 patients (9M/16F) were recruited. All patients underwent cough and Valsalva manoeuvre pressure tests to measure vesicle pressure (Pves) and abdominal pressure (Pabd). A single dual-lumen catheter (T-DOC 7Fr Air-Charged® catheter) was used to record air and water pressures simultaneously.
The primary outcome was to determine if the maximum pressures during Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 200 cc during a urodynamic evaluation.
Exploratory endpoints included the following:
- To determine if maximum pressures for cough, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100, 200 and Maximum Bladder Capacity (MBC) cc during a urodynamic evaluation.
- To determine if maximum pressures for Valsalva manoeuvres, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent when the bladder is filled to 100 and MBC cc during a urodynamic evaluation (as well as 200 cc which is the primary objective).
- To determine if the maximum voiding pressure, as measured with a single dual-lumen water-perfused and air-charged catheter, are equivalent.
- To determine if the clinical impressions of the urodynamic study are equivalent for the water-perfused and air-charged catheters.
- To determine if the compliance of the bladder is equivalent when measured by air-charged catheters as compared to water-perfused catheters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urodynamics with AC and WP | Experimental | Device: TDOC air-charged catheterPatients underwent a conventional urodynamics study utilizing a single catheter technique |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients normally indicated for urodynamic evaluations
Key exclusion criteria (4 listed)
- Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
- Patients who suffer from strictures in the urethra
- Patients who are pregnant
- Patients who require the use of a suprapubic catheter
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 |
|---|---|---|
| TDOC air-charged catheterUrodynamic study utilizing a single catheter technique to measure WP \& AC measurements | Device | Urodynamics with AC and WP |
Primary outcome
Maximum Vesical Pressure During Valsalva Manoeuvres
Time frame: Measured during a single urodynamic evaluation
Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Abdominal Pressure During Valsalva Manoeuvres
Time frame: Measured during a single urodynamic evaluation
Maximum abdominal pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
Maximum Detrusor Pressure at Valsalva Manoeuvres
Time frame: Measured during a single urodynamic evaluation
Maximum detrusor pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.
3 secondary outcomes
Maximum Vesical Pressure During Coughs
Time frame: Measured during a single urodynamic evaluation
Maximum Abdominal Pressure During Coughs
Time frame: Measured during a single urodynamic evaluation
Maximum Detrusor Pressure During Coughs
Time frame: Measured during a single urodynamic evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDOC air-charged catheter in people with Urodynamics, run by Laborie Medical Technologies Inc. at 1 site in Germany.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 2020. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Vesical Pressure During Valsalva Manoeuvres (time frame: Measured during a single urodynamic evaluation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.