Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Not Applicable

Completed

Conditions: Enlarged Prostate With Lower Urinary Tract Symptoms
Spinal Cord Injuries

Interventions: Device: SpeediCath

Registration Number: NCT03337048

Lead Sponsor: Coloplast A/S

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement of endpoints	SpeediCath	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.

Primary Outcome Measures

Name	Time	Method
Discomfort During Catheter Insertion on a Visual Analogue Scale	Filled out after 5 minutes per catheterisation.	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.

Secondary Outcome Measures