Urodynamic StudiesNCT06864117
Urodynamics: Prone Vs. Seated Position
A study testing Body position during urodynamics in people with Urodynamic Studies and Urodynamics, run by Kantonsspital Winterthur KSW.
Trial summary
To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the "conventional" pressure-flow studies according to the ICS standard with regard to the diagnosis of… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Urodynamic Studies, Urodynamics, Outlet Obstruction
- What is being tested?
- Body position during urodynamics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Genotype and phenotype XY
- Age between 18 and 90 years
- Signed informed consent form
- Ability to understand and follow the study procedures and understand the consent form
- possibility ti carry out out the necessary urodynamics as part of the regular clinical examination
- assessment of neurogenic and/or non-neurogenic (idiopathic) bladder dysfunction
- Spontaneous micturition in a sitting position is possible
Who cannot join
- Patients with assistance/patients under guardianship
- Patients with latex allergy or cross-allergy (banana, kiwi, fig, avocado)
- No spontaneous movement possible in a sitting position
- Sitting position not possible due to lack of trunk stability/circulatory problems
- Intravesical Botox injection during the last 9 months
About this study
Official title: Comparison of Urine Flow Measurements in the Context of Pressure Flow Studies in Men in Supine and Sitting Positions Using a Urinary Condom
To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the "conventional" pressure-flow studies according to the ICS standard with regard to the diagnosis of outlet obstruction in men.
Read the detailed description
The study aims to investigate a change in the measured values of a pressure-flow measurement in male patients between the sitting and lying position using a urinary condom. This offers enormous added value for science, as both a technique for carrying out the measurement and the effect of positioning can be evaluated. Due to anatomical conditions, this project will only be carried out with male patients. By carrying out the individual measurements in different examination positions on the same patient, influences caused by the change in position can be verified. It enables direct comparison of the criteria for outlet obstruction in the same patient and thus leads to confirmation or rejection of the hypothesis that the outlet obstruction criteria can be used for measurements in the supine position in the same way as for the measurement in the sitting position described by ICS. This project is therefore based on the question of whether the known analysis criteria for outlet obstruction are equivalent to the measurements recommended by ICS in the sitting position in male patients in whom pressure-flow studies can only be performed in the supine position. In addition, the use of a urinal condom with a drainage line as an aid or technique during the measurement is being investigated.
- Conditions
- Urodynamic Studies, Urodynamics, Outlet Obstruction
- Being tested
- Body position during urodynamics
- Keywords
- obstruction, urodynamics
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body position during urodynamicsOther
The group defines the body position in which the first and second measurements are taken.
Group A: sitting, lying down (s/l). Group B: lying down, sitting (l/s). According to the ICS standard, the third measurement is always taken in a sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Group A: sitting, lying down(s/l) | Other | Not described Receives: Other: Body position during urodynamics |
| Goup B: lying down, sitting (l/s) | Other | Not described Receives: Other: Body position during urodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
First sensation of filling, FSF [mL]
measured during storage phase
Measured: Periprocedural
First desire to void, FDV [mL]
measured during storage phase
Measured: Periprocedural
Strong desire to void, SDV [mL]
measured during storage phase
Measured: Periprocedural
Pdet(S) [cmH2O]
Maximum detrusor pressure, measured during storage phase
Measured: Periprocedural
Electromyography pelvic floor EMG [μV] during storage phase
Measured: Periprocedural
Filling volume [mL] during storage phase
Measured: Periprocedural
Compl [mL/cmH2O]
Compliance, measured during storage phase
Measured: Periprocedural
Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])
Measured: Periprocedural
Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])
measured during voiding phase
Measured: Periprocedural
Maximum flow rate (Qmax [mL/s]) during voiding phase
Measured: Periprocedural
Electromyography pelvic floor (EMG [μV]) during voiding phase
Measured: Periprocedural
Flow volume [mL] during voiding phase
Measured: Periprocedural
Residual urine volume (post void residual, PVR [mL])
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start28 Feb 2025 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urodynamic StudiesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864117
- Sponsor's protocol ID
- 2024-01522
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Urine Flow Measurements in the Context of Pressure Flow Studies in Men in Supine and Sitting Positions Using a Urinary Condom
- ClinicalTrials.gov ID
- NCT06864117
- Acronym / sponsor ID
- 2024-01522
- Conditions
- Urodynamic Studies, Urodynamics, Outlet Obstruction
- Keywords
- obstruction, urodynamics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 7 Mar 2025 (actual)
- 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.
To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the "conventional" pressure-flow studies according to the ICS standard with regard to the diagnosis of outlet obstruction in men.
Detailed description
The study aims to investigate a change in the measured values of a pressure-flow measurement in male patients between the sitting and lying position using a urinary condom. This offers enormous added value for science, as both a technique for carrying out the measurement and the effect of positioning can be evaluated. Due to anatomical conditions, this project will only be carried out with male patients. By carrying out the individual measurements in different examination positions on the same patient, influences caused by the change in position can be verified. It enables direct comparison of the criteria for outlet obstruction in the same patient and thus leads to confirmation or rejection of the hypothesis that the outlet obstruction criteria can be used for measurements in the supine position in the same way as for the measurement in the sitting position described by ICS. This project is therefore based on the question of whether the known analysis criteria for outlet obstruction are equivalent to the measurements recommended by ICS in the sitting position in male patients in whom pressure-flow studies can only be performed in the supine position. In addition, the use of a urinal condom with a drainage line as an aid or technique during the measurement is being investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: sitting, lying down(s/l) | Other | Other: Body position during urodynamics |
| Goup B: lying down, sitting (l/s) | Other | Other: Body position during urodynamics |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Genotype and phenotype XY
- Age between 18 and 90 years
- Signed informed consent form
- Ability to understand and follow the study procedures and understand the consent form
- possibility ti carry out out the necessary urodynamics as part of the regular clinical examination
Key exclusion criteria (5 listed)
- Patients with assistance/patients under guardianship
- Patients with latex allergy or cross-allergy (banana, kiwi, fig, avocado)
- No spontaneous movement possible in a sitting position
- Sitting position not possible due to lack of trunk stability/circulatory problems
- Intravesical Botox injection during the last 9 months
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 |
|---|---|---|
| Body position during urodynamicsThe group defines the body position in which the first and second measurements are taken. Group A: sitting, lying down (s/l). Group B: lying down, sitting (l/s). According to the ICS standard, the third measurement is always taken in a sitting position. | Other | Goup B: lying down, sitting (l/s), Group A: sitting, lying down(s/l) |
Primary outcome
First sensation of filling, FSF [mL]
Time frame: Periprocedural
measured during storage phase
First desire to void, FDV [mL]
Time frame: Periprocedural
measured during storage phase
Strong desire to void, SDV [mL]
Time frame: Periprocedural
measured during storage phase
Pdet(S) [cmH2O]
Time frame: Periprocedural
Maximum detrusor pressure, measured during storage phase
Electromyography pelvic floor EMG [μV] during storage phase
Time frame: Periprocedural
Filling volume [mL] during storage phase
Time frame: Periprocedural
Compl [mL/cmH2O]
Time frame: Periprocedural
Compliance, measured during storage phase
Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])
Time frame: Periprocedural
Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])
Time frame: Periprocedural
measured during voiding phase
Maximum flow rate (Qmax [mL/s]) during voiding phase
Time frame: Periprocedural
Electromyography pelvic floor (EMG [μV]) during voiding phase
Time frame: Periprocedural
Flow volume [mL] during voiding phase
Time frame: Periprocedural
Residual urine volume (post void residual, PVR [mL])
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Body position during urodynamics in people with Urodynamic Studies and Urodynamics, run by Kantonsspital Winterthur KSW.
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 7 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
First sensation of filling, FSF [mL] (time frame: Periprocedural). The study lists 13 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 7 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.