Comparison of Microtrauma in Urethra After Usage of Different Catheters

Not Applicable

Terminated

• Conditions: Hematuria
• Interventions: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male

• Registration Number: NCT01600443
• Lead Sponsor: Wellspect HealthCare

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-24
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LoFric - SC - SCCM	LoFric	Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
LoFric - SC - SCCM	SpeediCath	Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
SC - LoFric - SCCM	SpeediCath	Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
SC - LoFric - SCCM	SpeediCath Compact Male	Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
SCCM - LoFric - SC	LoFric	Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
SCCM - LoFric - SC	SpeediCath	Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
SCCM - LoFric - SC	SpeediCath Compact Male	Study period 1: SpeediCath Compact Male Study period 2: LoFric Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
SCCM - SC - LoFric	LoFric	Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
SCCM - SC - LoFric	SpeediCath	Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
SCCM - SC - LoFric	SpeediCath Compact Male	Study period 1: SpeediCath Compact Male Study period 2: SpeediCath Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
SC - SCCM - LoFric	SpeediCath	Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
SC - SCCM - LoFric	SpeediCath Compact Male	Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.
SC - LoFric - SCCM	LoFric	Study period 1: SpeediCath Study period 2: LoFric Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
LoFric - SC - SCCM	SpeediCath Compact Male	Study period 1: LoFric Study period 2: SpeediCath Study period 3: SpeediCath Compact Male In each study period three catheterizations are made, separated by at least 2 hours.
LoFric - SCCM - SC	LoFric	Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
LoFric - SCCM - SC	SpeediCath	Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
LoFric - SCCM - SC	SpeediCath Compact Male	Study period 1: LoFric Study period 2: SpeediCath Compact Male Study period 3: SpeediCath In each study period three catheterizations are made, separated by at least 2 hours.
SC - SCCM - LoFric	LoFric	Study period 1: SpeediCath Study period 2: SpeediCath Compact Male Study period 3: LoFric In each study period three catheterizations are made, separated by at least 2 hours.

Primary Outcome Measures

Name	Time	Method
Hematuria	Approximately 2 hours after last catheterization	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.

Secondary Outcome Measures

Name	Time	Method
Hematuria	At first, second and third catheterization, approximately 2 hours apart	Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
Pyuria	Approximately 2 hours after last catheterization	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.

Trial Locations

Locations (1)

Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital; 🇸🇪 Lund, Sweden