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 range18 Years

SexMALE

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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

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