Comparison of Microtrauma in Urethra After Usage of Different Catheters

This study has been terminated.
(Planned interim analysis showed study was underpowered)
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT01600443
First received: April 24, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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%.


Condition Intervention
Hematuria
Device: LoFric
Device: SpeediCath
Device: SpeediCath Compact Male

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.

Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Hematuria [ Time Frame: Approximately 2 hours after last catheterization ] [ Designated as safety issue: Yes ]
    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:
  • Hematuria [ Time Frame: At first, second and third catheterization, approximately 2 hours apart ] [ Designated as safety issue: Yes ]
    Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.

  • Pyuria [ Time Frame: At first, second and third catheterization, approximately 2 hours apart ] [ Designated as safety issue: Yes ]
    White blood cells in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.

  • Pyuria [ Time Frame: Approximately 2 hours after last catheterization ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 21
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LoFric - SC - SCCM
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.
Device: LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
Device: SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
Device: SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Experimental: LoFric - SCCM - SC
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.
Device: LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
Device: SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
Device: SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Experimental: SC - SCCM - 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.
Device: LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
Device: SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
Device: SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Experimental: SC - LoFric - SCCM
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.
Device: LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
Device: SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
Device: SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Experimental: SCCM - LoFric - SC
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.
Device: LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
Device: SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
Device: SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
Experimental: SCCM - SC - 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.
Device: LoFric
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
Device: SpeediCath
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
Device: SpeediCath Compact Male
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600443

Locations
Sweden
Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Wellspect HealthCare
Investigators
Principal Investigator: Ulf Malmkvist, Assoc Prof Skåne University Hospital
  More Information

No publications provided

Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT01600443     History of Changes
Other Study ID Numbers: LOF-0022
Study First Received: April 24, 2012
Last Updated: January 31, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Hematuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014