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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT00913510
First received: June 3, 2009
Last updated: January 3, 2014
Last verified: January 2014
  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:


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 of London
  More Information

No publications provided

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014