Urodynamics: Prone Vs. Seated Position (NCT06864117) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Urodynamics: Prone Vs. Seated Position
200 participantsStarted 2025-02-28
Plain-language 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 outlet obstruction in men.
Who can participate
Age range
18 Years – 90 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First sensation of filling, FSF [mL]
Timeframe: Periprocedural
2
First desire to void, FDV [mL]
Timeframe: Periprocedural
3
Strong desire to void, SDV [mL]
Timeframe: Periprocedural
4
Pdet(S) [cmH2O]
Timeframe: Periprocedural
5
Electromyography pelvic floor EMG [μV] during storage phase
Timeframe: Periprocedural
6
Filling volume [mL] during storage phase
Timeframe: Periprocedural
7
Compl [mL/cmH2O]
Timeframe: Periprocedural
8
Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])