Status:
COMPLETED
Exploratory Study Investigating Urodynamic Parameters During Catheterisation
Lead Sponsor:
Coloplast A/S
Conditions:
Spinal Cord Injuries
Enlarged Prostate With Lower Urinary Tract Symptoms
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.
Detailed Description
The investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with SCI and 10 patients with BPH. The healthy volunteers included int...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03337048
Start Date
November 30 2017
End Date
May 29 2018
Last Update
August 12 2024
Active Locations (1)
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1
Department of Urology, Rigshospitalet
Copenhagen, Denmark, 2100