Clinical trial NCT03337048: Exploratory Study Investigating Urodynamic Parameters During Catheterisation
Official title: Exploratory Study Investigating Urodynamic Parameters During Catheterisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Enlarged Prostate With Lower Urinary Tract Symptoms
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discomfort During Catheter Insertion on a Visual Analogue Scale
timeFrame: Filled out after 5 minutes per catheterisation.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Urology, Rigshospitalet
Study officials:
affiliation: Vice president Medical Affairs
name: Nazarena Mazarro
role: STUDY_DIRECTOR
References: