Back to resultsExploratory Study Investigating Urodynamic Parameters During Catheterisation
Primary Purpose
Spinal Cord Injuries, Enlarged Prostate With Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SpeediCath
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injuries
Eligibility Criteria
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
Sites / Locations
- Department of Urology, Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Measurement of endpoints
Arm Description
In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter (SpeediCath). In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter.
Outcomes
Primary Outcome Measures
Discomfort during catheter insertion on a Visual Analogue Scale
Urodynamic examination: On a scale ranging from "no discomfort" to "worst possible discomfort comfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03337048
Brief Title
Exploratory Study Investigating Urodynamic Parameters During Catheterisation
Official Title
Exploratory Study Investigating Urodynamic Parameters During Catheterisation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
May 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Enlarged Prostate With Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Measurement of endpoints
Arm Type
Experimental
Arm Description
In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter (SpeediCath).
In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter.
Intervention Type
Device
Intervention Name(s)
SpeediCath
Intervention Description
SpeediCath is a standard intermittent catheter that is on the market.
Primary Outcome Measure Information:
Title
Discomfort during catheter insertion on a Visual Analogue Scale
Description
Urodynamic examination: On a scale ranging from "no discomfort" to "worst possible discomfort comfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter
Time Frame
1 hour
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male subjects are included as the intermittent catheter used in the investigation is a male catheter
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazarena Mazarro
Organizational Affiliation
Vice president Medical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Department of Urology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Exploratory Study Investigating Urodynamic Parameters During Catheterisation
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