Comparison of Microtrauma in Urethra After Usage of Different Catheters

Hematuria Clinical Trial

Official title:

A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01600443
• Other study ID #: LOF-0022
• Status: Terminated
• Phase: N/A
• First received: April 24, 2012
• Last updated: January 31, 2014
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematuria

Intervention

Device:
• LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
• SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
• SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.

Locations

Country	Name	City	State
Sweden	Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematuria	Blood in urine (measured by microscopic urine sediment evaluation) will be assessed at the first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.	Approximately 2 hours after last catheterization	Yes
Secondary	Hematuria	Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.	At first, second and third catheterization, approximately 2 hours apart	Yes
Secondary	Pyuria	White blood cells in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.	At first, second and third catheterization, approximately 2 hours apart	Yes
Secondary	Pyuria	White blood cells in urine (measured by microscopic urine sediment evaluation) will be assessed at first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.	Approximately 2 hours after last catheterization	Yes