Enlarged Prostate With Lower Urinary Tract Symptoms, Spinal Cord Injuries
Conditions
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.
Interventions
DEVICESpeediCath
SpeediCath is a standard intermittent catheter that is on the market.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Urodynamic Parameters During Catheterisation Exploratory measurements of Urodynamic parameters | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Urodynamic Parameters During Catheterisation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 10 Participants | — |
| Age, Categorical Between 18 and 65 years | 20 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 30 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: Filled out after 5 minutes per catheterisation.
Population: 8 healthy volunteers, 10 subjects with spinal cord injury and 10 subjects with enlarged prostate
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Measurement of Endpoints | Discomfort During Catheter Insertion on a Visual Analogue Scale | healthy volunteers | 1.2 score on a scale |
| Measurement of Endpoints | Discomfort During Catheter Insertion on a Visual Analogue Scale | Spinal Cord Injury | 1.0 score on a scale |
| Measurement of Endpoints | Discomfort During Catheter Insertion on a Visual Analogue Scale | Benign prostatic hyperplasia | 1.1 score on a scale |