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
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Dysfunction Multiple Sclerosis | Device: CIC using LoFric Primo Drug: Anticholinergic medication | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: CIC using LoFric Primo
Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
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Device: 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, i.e. Drug + Device.
Other Name: LoFric Primo Drug: Anticholinergic medication Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug. |
Active Comparator: Anticholinergic medication
Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
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Drug: Anticholinergic medication
Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug. |
- Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. [ Time Frame: 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%.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913510
Belgium | |
Centre Hospitalier Universitaire de Liège Ourthe Ambléve | |
Esneux, Belgium, 4130 | |
UZ Gasthuisberg | |
Leuven, Belgium, 3000 | |
Germany | |
St. Hedwig Hospital, Department of Urology | |
Berlin, Germany, 10115 | |
Netherlands | |
UMC ST Radboud Nijmegen, Department of Urology | |
Nijmegen, Netherlands, 6500 HB | |
United Kingdom | |
University College of London, Institute of Neurology | |
London, United Kingdom, WC1N 3BG |
Principal Investigator: | Clare Fowler, Prof. | University College, London |
Responsible Party: | Wellspect HealthCare |
ClinicalTrials.gov Identifier: | NCT00913510 |
Other Study ID Numbers: |
YA-MSP-0001 |
First Posted: | June 4, 2009 Key Record Dates |
Results First Posted: | January 6, 2014 |
Last Update Posted: | January 6, 2014 |
Last Verified: | January 2014 |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |