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

Purpose

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	Intervention
Bladder Dysfunction Multiple Sclerosis	Device: CIC using LoFric Primo Drug: Anticholinergic medication


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:

Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. [ Time Frame: Baseline and 8 weeks after randomization. ] [ Designated as safety issue: No ]
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%.


Enrollment:	24
Study Start Date:	December 2009
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.	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.

Arms

Assigned Interventions

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.

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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913510

Locations


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

Sponsors and Collaborators

Wellspect HealthCare

Investigators


Principal Investigator:	Clare Fowler, Prof.	University College, London

More Information


Responsible Party:	Wellspect HealthCare
ClinicalTrials.gov Identifier:	NCT00913510 History of Changes
Other Study ID Numbers:	YA-MSP-0001
Study First Received:	June 3, 2009
Results First Received:	June 27, 2013
Last Updated:	January 3, 2014
Health Authority:	Belgium: Institutional Review Board Germany: Ethics Commission Netherlands: Independent Ethics Committee United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:


Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases	Immune System Diseases Pathologic Processes Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016