A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation

• Sponsor: Wellspect HealthCare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00753298
• Collaborator: (none)
• Enrollment: 195
• Locations: 13
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 15
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.

Condition or Disease	Intervention/Treatment	Phase
Urinary Catheterization	Device: LoFric Primo (POBE) single-use urinary catheter; Device: LoFric Primo (PVC) single-use urinary catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-centre, Double-blind, Randomized, Parallel Groups Study Comparing PVC and Polyolefin-based Elastomer (POBE) as Catheter Materials, Outcomes Will be Measured by Subject Perception.
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LoFric Primo (POBE) single-use urinary catheter	Device: LoFric Primo (POBE) single-use urinary catheter; LoFric Primo (POBE) single-use urinary catheter
Active Comparator: LoFric Primo (PVC) single-use urinary catheter	Device: LoFric Primo (PVC) single-use urinary catheter; LoFric Primo (PVC) single-use urinary catheter

Outcome Measures

Primary Outcome Measures

1. Subject's Perception Regarding Handling of Test Catheter Before Insertion [At 4 weeks]

   Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

2. Subject's Perception Regarding Handling of Test Catheter at Insertion [At 4 weeks]

   Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

3. Subject's Perception Regarding Handling of Test Catheter at Withdrawal [At 4 weeks]

   Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

4. Subject's Perception Regarding Handling of Test Catheter After Withdrawal [At 4 weeks]

   Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)

5. Subject's General Satisfaction With Test Catheter [At 4 weeks]

   Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)

6. Subject's Sensation When Using Test Catheter [At 4 weeks]

   Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of informed consent

• Males and females aged 18 years and over

• Experienced users of LoFric Primo with a minimum of one month of use

• Practice CIC with LoFric Primo at least 3 times per day

• Adults able to read, write and understand information given to them regarding the study

Exclusion Criteria:

• Ongoing symptomatic UTI

• Suspicions of possible poor compliance with CIC during the study period

• Previous enrolment or randomisation of treatment in the present study

• Pregnancy

• Subjects not able to perform self-catheterisation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Urology	Vienna		Austria	A-1090
2	NRZ Greifswald	Greifswald		Germany	17487
3	Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus	Mönchengladbach		Germany	41063
4	BG-Klinik Tübingen	Tübingen		Germany	72076
5	Ospedale Careggi, Unità Spinale	Firenze		Italy	50139
6	Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni	Torino		Italy
7	Ziekenhuis Lievensberg, Afdeling Urologie	Bergen op Zoom		Netherlands	4624 VT
8	Albert Schweitzer Ziekenhuis, Locatie Dordwijk	Dordrecht		Netherlands	3300 AK
9	Catharina Ziekenhuis	Eindhoven		Netherlands	5602 ZA
10	Radboud Univesity Nijmegen Medical Centre	Nijmegen		Netherlands	6500 HB
11	Verksamhet Urologi, Sahlgrenska Universitets sjukhuset	Göteborg		Sweden	413 45
12	Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF
13	Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore	Stanmore		United Kingdom	HA7 4LP

Sponsors and Collaborators

• Wellspect HealthCare

Investigators

• Principal Investigator: Alfred J Witjes, Prof Dr, Radboud Univesity Nijmegen Medical Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wellspect HealthCare
• ClinicalTrials.gov Identifier: NCT00753298
• Other Study ID Numbers: YA-CLO-0002
• First Posted: Sep 16, 2008
• Last Update Posted: Nov 11, 2021
• Last Verified: Sep 1, 2012

Study Results

Participant Flow

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Period Title: Overall Study
STARTED	97	98
COMPLETED	89	94
NOT COMPLETED	8	4

Baseline Characteristics

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)	Total
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)	Total of all reporting groups
Overall Participants	97	98	195
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	74 76.3%	74 75.5%	148 75.9%
>=65 years	23 23.7%	24 24.5%	47 24.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.5 (16.16)	51.1 (17.20)	52 (16.66)
Sex: Female, Male (Count of Participants)
Female	25 25.8%	19 19.4%	44 22.6%
Male	72 74.2%	79 80.6%	151 77.4%
Region of Enrollment (participants) [Number]
Austria	16 16.5%	18 18.4%	34 17.4%
Germany	22 22.7%	20 20.4%	42 21.5%
Netherlands	22 22.7%	22 22.4%	44 22.6%
United Kingdom	2 2.1%	1 1%	3 1.5%
Italy	21 21.6%	23 23.5%	44 22.6%
Sweden	14 14.4%	14 14.3%	28 14.4%

Outcome Measures

1. Primary Outcome

Title	Subject's Perception Regarding Handling of Test Catheter Before Insertion
Description	Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time Frame	At 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Measure Participants	89	94
Mean (Standard Deviation) [Score on scale]	1.71 (1.13)	1.76 (1.05)

2. Primary Outcome

Title	Subject's Perception Regarding Handling of Test Catheter at Insertion
Description	Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time Frame	At 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Measure Participants	89	94
Mean (Standard Deviation) [Score on scale]	1.81 (1.23)	1.55 (0.84)

3. Primary Outcome

Title	Subject's Perception Regarding Handling of Test Catheter at Withdrawal
Description	Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time Frame	At 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Measure Participants	89	94
Mean (Standard Deviation) [Score on scale]	1.55 (0.93)	1.44 (0.77)

4. Primary Outcome

Title	Subject's Perception Regarding Handling of Test Catheter After Withdrawal
Description	Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time Frame	At 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Measure Participants	89	94
Mean (Standard Deviation) [Score on scale]	1.63 (1.05)	1.69 (0.98)

5. Primary Outcome

Title	Subject's General Satisfaction With Test Catheter
Description	Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)
Time Frame	At 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Measure Participants	89	94
Mean (Standard Deviation) [Score on scale]	2.01 (0.99)	1.75 (0.68)

6. Primary Outcome

Title	Subject's Sensation When Using Test Catheter
Description	Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)
Time Frame	At 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LoFric Primo (POBE)	LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)	LoFric Primo (PVC) single-use urinary catheter (Arm B)
Measure Participants	89	94
Mean (Standard Deviation) [Score on scale]	1.86 (0.90)	1.91 (0.92)

Adverse Events

Arm/Group Title	LoFric Primo (POBE)		LoFric Primo (PVC)
Arm/Group Description	LoFric Primo (POBE) single-use urinary catheter (Arm A)		LoFric Primo (PVC) single-use urinary catheter (Arm B)
All Cause Mortality
	LoFric Primo (POBE)		LoFric Primo (PVC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LoFric Primo (POBE)		LoFric Primo (PVC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/97 (2.1%)		1/98 (1%)
Blood and lymphatic system disorders
Sepsis due to Urinary Tract Infection	0/97 (0%)		1/98 (1%)
Nervous system disorders
Hospitalization due to neurological problems	1/97 (1%)		0/98 (0%)
Pseudotumor cerebri	1/97 (1%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	LoFric Primo (POBE)		LoFric Primo (PVC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/97 (3.1%)		7/98 (7.1%)
Renal and urinary disorders
Urinary Tract Infection	3/97 (3.1%)		7/98 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Astra Tech shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed in order for Astra Tech to file patent applications.