Trial Outcomes & Findings for Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction (NCT NCT00913510)

Results Overview

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%.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline and 8 weeks after randomization.

Results posted on

2021-11-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	CIC Using LoFric Primo 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 Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
Overall Study STARTED	13	7
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CIC Using LoFric Primo n=13 Participants 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 n=7 Participants Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.	Total n=20 Participants Total of all reporting groups
Age, Continuous	41.15 years STANDARD_DEVIATION 12.86 • n=5 Participants	51.71 years STANDARD_DEVIATION 8.34 • n=7 Participants	44.85 years STANDARD_DEVIATION 12.38 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks after randomization.

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%.

Outcome measures

Outcome measures
Measure	CIC Using LoFric Primo n=5 Participants 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 n=3 Participants Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.	-9.09 percent change Standard Deviation 27.82	-6.41 percent change Standard Deviation 33.15

Adverse Events

CIC Using LoFric Primo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Anticholinergic Medication

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CIC Using LoFric Primo n=13 participants at risk 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 n=7 participants at risk Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Renal and urinary disorders Urinary Tract Infection	7.7% 1/13 • Number of events 1	0.00% 0/7

Other adverse events

Other adverse events
Measure	CIC Using LoFric Primo n=13 participants at risk 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 n=7 participants at risk Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Renal and urinary disorders Urinary Tract Infection	7.7% 1/13 • Number of events 2	14.3% 1/7 • Number of events 1

Additional Information

Dikran Shamoun

Wellspect HealthCare

Phone: +46313764000

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60