Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction

• ClinicalTrials.gov Identifier: NCT00913510
• Recruitment Status: Terminated
• First Posted: June 4, 2009
• Results First Posted: January 6, 2014
• Last Update Posted: January 6, 2014
• Sponsor: Wellspect HealthCare
• Information provided by (Responsible Party): Wellspect HealthCare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Bladder Dysfunction; Multiple Sclerosis
• Interventions: Device: CIC using LoFric Primo; Drug: Anticholinergic medication
• Enrollment: 24

Participant Flow

Recruitment Details
Pre-assignment Details	The study had a screening period between enrolment and randomization. Four (4) of the enroled patients were never randomized due to either withdrawal of consent or not fulfilling inclusion/exclusion criteria at randomization.

Arm/Group Title	CIC Using LoFric Primo	Anticholinergic Medication
Arm/Group Description	Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters.	Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
Period Title: Overall Study
Started	13	7
Completed	5	3
Not Completed	8	4

Baseline Characteristics

Arm/Group Title		CIC Using LoFric Primo	Anticholinergic Medication	Total
Arm/Group Description		Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device	Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.	Total of all reporting groups
Overall Number of Baseline Participants		13	7	20
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants	7 participants	20 participants
		41.15 (12.86)	51.71 (8.34)	44.85 (12.38)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	7 participants	20 participants
	Female	9 69.2%	3 42.9%	12 60.0%
	Male	4 30.8%	4 57.1%	8 40.0%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Description	Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%.
Time Frame	Baseline and 8 weeks after randomization.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CIC Using LoFric Primo	Anticholinergic Medication
Arm/Group Description:	Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device	Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Overall Number of Participants Analyzed	5	3
Mean (Standard Deviation); Unit of Measure: percent change
	-9.09 (27.82)	-6.41 (33.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CIC Using LoFric Primo, Anticholinergic Medication
	Comments	H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group. Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.0000
	Comments	The p-value is calculated to the fourth decimal place.
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	CIC Using LoFric Primo		Anticholinergic Medication
Arm/Group Description	Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device		Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
All-Cause Mortality
	CIC Using LoFric Primo		Anticholinergic Medication
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	CIC Using LoFric Primo		Anticholinergic Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.69%)		0/7 (0.00%)
Renal and urinary disorders
Urinary Tract Infection	1/13 (7.69%)	1	0/7 (0.00%)	0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CIC Using LoFric Primo		Anticholinergic Medication
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.69%)		1/7 (14.29%)
Renal and urinary disorders
Urinary Tract Infection	1/13 (7.69%)	2	1/7 (14.29%)	1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dikran Shamoun
• Organization: Wellspect HealthCare
• Phone: +46313764000

• Responsible Party: Wellspect HealthCare
• ClinicalTrials.gov Identifier: NCT00913510
• Other Study ID Numbers: YA-MSP-0001
• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Results First Submitted: June 27, 2013
• Results First Posted: January 6, 2014
• Last Update Posted: January 6, 2014