Clinical trial NCT01600443: Comparison of Microtrauma in Urethra After Usage of Different Catheters
Official title: A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematuria
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study.

Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week.

The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization.

The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization.

The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality.

The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.


Eligibility criteria: Inclusion criteria:

1. Provision of informed consent
2. Healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half \>50 years old)
3. Negative urine dipstick test (no blood in the urine) before randomization

Exclusion Criteria:

1. Intake of anticoagulants at enrolment and during the study period
2. Intake of antibiotics at enrolment and during the study period
3. Urinary tract infection (UTI) at enrolment and during the study period
4. Known abnormalities or diseases of the lower urinary tract with the exception of BPH
5. Kidney stones
6. Tumour in the urinary tract
7. Known Sexually transferable diseases in the urinary tract during the study period
8. Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
9. Previous enrolment or randomisation of treatment in the present study
10. Simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator
11. Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

Primary outcomes:
measure: Hematuria
timeFrame: Approximately 2 hours after last catheterization
Secondary outcomes:
measure: Hematuria
timeFrame: At first, second and third catheterization, approximately 2 hours apart
measure: Pyuria
timeFrame: At first, second and third catheterization, approximately 2 hours apart
measure: Pyuria
timeFrame: Approximately 2 hours after last catheterization
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital
Study officials:
affiliation: Skane University Hospital
name: Ulf Malmkvist, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: