Exploratory Study Investigating Urodynamic Parameters During Catheterisation

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Enlarged Prostate With Lower Urinary Tract Symptoms
• Intervention / Treatment: Device: SpeediCath

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 into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard IC (4-15 days after visit 1). (Visit 0 and visit 1 can be the same day).

The subjects with SCI and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (Most IC users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). The second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard IC (4-15 days after visit 0 while subject is on prophylaxis antibiotics).

The investigation is conducted at one site and is an explorative study, estimated to last eight (8) months.

Due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Urology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measurement of endpoints; 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; SpeediCath is a standard intermittent catheter that is on the market.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Director: Nazarena Mazarro, Vice president Medical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): May 29, 2018
• Study Completion (Actual): May 29, 2018

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urological Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Lower Urinary Tract Symptoms; Spinal Cord Injuries
• Other Study ID Numbers: CP277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No