HematuriaNCT01600443
Comparison of Microtrauma in Urethra After Usage of Different Catheters
A study testing LoFric, SpeediCath and SpeediCath Compact Male in people with Hematuria, run by Wellspect HealthCare at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hematuria
- What is being tested?
- LoFric, SpeediCath and SpeediCath Compact Male
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- 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)
- Negative urine dipstick test (no blood in the urine) before randomization
Who cannot join
- Intake of anticoagulants at enrolment and during the study period
- Intake of antibiotics at enrolment and during the study period
- Urinary tract infection (UTI) at enrolment and during the study period
- Known abnormalities or diseases of the lower urinary tract with the exception of BPH
- Kidney stones
- Tumour in the urinary tract
Show all 11Show fewer
- Known Sexually transferable diseases in the urinary tract during the study period
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
- Simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Trial Unit, R&D Centre Skåne, Skåne University Hospital
Lund, 221 85
About this study
Official title: A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.
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.
Read more
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%.
- Conditions
- Hematuria
- Being tested
- LoFric, SpeediCath, SpeediCath Compact Male
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFricDevice
Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
SpeediCathDevice
Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
SpeediCath Compact MaleDevice
Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
| Study group | Role | What they receive |
|---|---|---|
| LoFric - SC - SCCM | Experimental | 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. Receives: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male |
| LoFric - SCCM - SC | Experimental | 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. Receives: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male |
| SC - SCCM - LoFric | Experimental | 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. Receives: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male |
| SC - LoFric - SCCM | Experimental | 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. Receives: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male |
| SCCM - LoFric - SC | Experimental | 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. Receives: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male |
| SCCM - SC - LoFric | Experimental | 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. Receives: Device: LoFric; Device: SpeediCath; Device: SpeediCath Compact Male |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 2 hours after last catheterization
Secondary outcomes (3)
Hematuria
Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
Measured: At first, second and third catheterization, approximately 2 hours apart
Pyuria
White blood cells in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
Measured: At first, second and third catheterization, approximately 2 hours apart
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.
Measured: Approximately 2 hours after last catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Planned interim analysis showed study was underpowered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulf Malmkvist, Assoc Prof, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600443
- Sponsor's protocol ID
- LOF-0022
- Status last verified
- Jan 2014
- First submitted
- 24 Apr 2012
- Last updated
- 3 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.
- ClinicalTrials.gov ID
- NCT01600443
- Acronym / sponsor ID
- LOF-0022
- Conditions
- Hematuria
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned interim analysis showed study was underpowered
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LoFric - SC - SCCM | Experimental | Device: LoFric, Device: SpeediCath, Device: SpeediCath Compact MaleStudy 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 | Experimental | Device: LoFric, Device: SpeediCath, Device: SpeediCath Compact MaleStudy 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 | Experimental | Device: LoFric, Device: SpeediCath, Device: SpeediCath Compact MaleStudy 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 | Experimental | Device: LoFric, Device: SpeediCath, Device: SpeediCath Compact MaleStudy 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 | Experimental | Device: LoFric, Device: SpeediCath, Device: SpeediCath Compact MaleStudy 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 | Experimental | Device: LoFric, Device: SpeediCath, Device: SpeediCath Compact MaleStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent
- 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)
- Negative urine dipstick test (no blood in the urine) before randomization
Key exclusion criteria (11 listed)
- Intake of anticoagulants at enrolment and during the study period
- Intake of antibiotics at enrolment and during the study period
- Urinary tract infection (UTI) at enrolment and during the study period
- Known abnormalities or diseases of the lower urinary tract with the exception of BPH
- Kidney stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoFricThree catheterizations at least two hours apart using LoFric Primo 40 cm CH14. | Device | LoFric - SC - SCCM, LoFric - SCCM - SC, SC - LoFric - SCCM, SC - SCCM - LoFric, SCCM - LoFric - SC, SCCM - SC - LoFric |
| SpeediCathThree catheterizations at least two hours apart using SpeediCath 40 cm CH14. | Device | LoFric - SC - SCCM, LoFric - SCCM - SC, SC - LoFric - SCCM, SC - SCCM - LoFric, SCCM - LoFric - SC, SCCM - SC - LoFric |
| SpeediCath Compact MaleThree catheterizations at least two hours apart using SpeediCath Compact Male 30 cm. | Device | LoFric - SC - SCCM, LoFric - SCCM - SC, SC - LoFric - SCCM, SC - SCCM - LoFric, SCCM - LoFric - SC, SCCM - SC - LoFric |
Primary outcome
Hematuria
Time frame: 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.
3 secondary outcomes
Hematuria
Time frame: At first, second and third catheterization, approximately 2 hours apart
Pyuria
Time frame: At first, second and third catheterization, approximately 2 hours apart
Pyuria
Time frame: Approximately 2 hours after last catheterization
Results and safety
The study was stopped early (reason given: Planned interim analysis showed study was underpowered). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
Related trials for Hematuria
Active, not recruitingObservational study
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Urothelial Carcinoma
RecruitingObservational study
Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population
UTUC, UC (Urothelial Cancer)
Not yet recruitingPhase 3
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
Recruiting
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
Hematuria - Cause Not Known
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Malmkvist, Assoc Prof principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric, SpeediCath and SpeediCath Compact Male in people with Hematuria, run by Wellspect HealthCare at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Planned interim analysis showed study was underpowered). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematuria (time frame: Approximately 2 hours after last catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.