Exploratory Study Investigating Urodynamic Parameters During Catheterisation

NCT03337048 | Completed Results

• 1 other identifier: CP277
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Enlarged Prostate With Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Discomfort During Catheter Insertion on a Visual Analogue Scale

  On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome.

  Filled out after 5 minutes per catheterisation.

Study Arms (1)

Measurement of endpoints

EXPERIMENTAL

In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter. In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter.

Device: SpeediCath

Interventions

SpeediCath DEVICE

SpeediCath is a standard intermittent catheter that is on the market.

Measurement of endpoints

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male subjects are included as the intermittent catheter used in the investigation is a male catheter
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)
• For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Department of Urology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Coloplast A/S

clinical-studies@coloplast.com

+45 49111111

Study Officials

• Nazarena Mazarro

  Vice president Medical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 8, 2017
• Study Start: November 30, 2017
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

Locations

DK (1)