Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Spinal Cord Injuries Clinical Trial

Official title:

Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337048
• Other study ID #: CP277
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: May 29, 2018

Study information

• Verified date: December 2017
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

3. Be male

4. For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit

5. For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture

6. For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months

Exclusion Criteria:

1. Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)

2. Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion ? termination)

3. For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Related Conditions & MeSH terms

• Enlarged Prostate With Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms
• Spinal Cord Injuries

Intervention

Device:
• SpeediCath
SpeediCath is a standard intermittent catheter that is on the market.

Locations

Country	Name	City	State
Denmark	Department of Urology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour