Back to resultsEfficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
Primary Purpose
Bladder Dysfunction, Multiple Sclerosis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CIC using LoFric Primo
Anticholinergic medication
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent
- Male and female patients aged 18 years and over
- MS patients that are already currently treated or eligible for treatment with anticholinergic drugs
- Patient with previously confirmed multiple sclerosis according to McDonald Criteria and level of disability less than 6.5 on the Kutzke scale and have been stable for 6 months
- The patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, PVR
- The patient has Frequency symptoms > 8 voiding per 24 h
- The patient has PVR > 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
- Adequate mobility to lower limbs, sufficient hand function and ability to practice CIC at least three times daily
Exclusion Criteria:
- Pregnancy
- Ongoing symptomatic Urinary Tract Infection (UTI) as judged by investigator
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- The patient practices CIC prior the study
- The patient has undergone a sphincterectomy
- Progressive "Relapsing- remitting MS" as judged by the investigator
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- The patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
- PVR > 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if Bladder Voiding Efficiency (BVE) at visit 2 (randomization) is 50% or less than visit 1 (screening)
Sites / Locations
- Centre Hospitalier Universitaire de Liège Ourthe Ambléve
- UZ Gasthuisberg
- St. Hedwig Hospital, Department of Urology
- UMC ST Radboud Nijmegen, Department of Urology
- University College of London, Institute of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CIC using LoFric Primo
Anticholinergic medication
Arm Description
Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
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%.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913510
Brief Title
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
Official Title
Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wellspect HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aims of this prospective, randomized study are:
To assess the effect of clean intermittent catheterization (CIC)
To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs
To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL
To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Dysfunction, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CIC using LoFric Primo
Arm Type
Experimental
Arm Description
Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
Arm Title
Anticholinergic medication
Arm Type
Active Comparator
Arm Description
Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Intervention Type
Device
Intervention Name(s)
CIC using LoFric Primo
Other Intervention Name(s)
LoFric Primo
Intervention 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, i.e. Drug + Device.
Intervention Type
Drug
Intervention Name(s)
Anticholinergic medication
Intervention Description
Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.
Primary Outcome Measure Information:
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent
Male and female patients aged 18 years and over
MS patients that are already currently treated or eligible for treatment with anticholinergic drugs
Patient with previously confirmed multiple sclerosis according to McDonald Criteria and level of disability less than 6.5 on the Kutzke scale and have been stable for 6 months
The patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, PVR
The patient has Frequency symptoms > 8 voiding per 24 h
The patient has PVR > 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
Adequate mobility to lower limbs, sufficient hand function and ability to practice CIC at least three times daily
Exclusion Criteria:
Pregnancy
Ongoing symptomatic Urinary Tract Infection (UTI) as judged by investigator
Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
The patient practices CIC prior the study
The patient has undergone a sphincterectomy
Progressive "Relapsing- remitting MS" as judged by the investigator
Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
The patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
PVR > 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if Bladder Voiding Efficiency (BVE) at visit 2 (randomization) is 50% or less than visit 1 (screening)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare Fowler, Prof.
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Liège Ourthe Ambléve
City
Esneux
ZIP/Postal Code
4130
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
St. Hedwig Hospital, Department of Urology
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
UMC ST Radboud Nijmegen, Department of Urology
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
University College of London, Institute of Neurology
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
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