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

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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:
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
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
Hide 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
Arm/Group Title CIC Using LoFric Primo Anticholinergic Medication Total
Hide 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
Hide 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%
1.Primary Outcome
Title Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CIC Using LoFric Primo Anticholinergic Medication
Hide 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)
Hide 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]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CIC Using LoFric Primo Anticholinergic Medication
Hide 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   --/--      --/--    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Dikran Shamoun
Organization: Wellspect HealthCare
Phone: +46313764000
Layout table for additonal information
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