CompletedNot Applicable

Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Denmark30 participantsStarted 2017-11-30

Plain-language summary

The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.

Who can participate

Age range

18 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

. Have given written informed consent
. Be at least 18 years of age and have full legal capacity
. Be male
. For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit
. For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture
. For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months

Exclusion criteria

. Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)
. Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination)
. For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract

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

Discomfort During Catheter Insertion on a Visual Analogue Scale

Timeframe: Filled out after 5 minutes per catheterisation.

Trial details

NCT IDNCT03337048

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-29

Results submitted2020-01-31

View on ClinicalTrials.gov More Spinal Cord Injuries trials