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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

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 4, 2009
Results First Submitted Date  ICMJE June 27, 2013
Results First Posted Date  ICMJE January 6, 2014
Last Update Posted Date January 6, 2014
Study Start Date  ICMJE December 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2014)
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%.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Frequency of micturition per day [ Time Frame: At screening, Visit 2 (1-4 weeks after screening), Visit 3 (8 weeks after visit 2) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
Official Title  ICMJE Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Dysfunction
  • Multiple Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: CIC using LoFric Primo
    • Drug: Anticholinergic medication
  • Active Comparator: Anticholinergic medication
    Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
    Intervention: Drug: Anticholinergic medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 3, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
60
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Netherlands,   United Kingdom
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00913510
Other Study ID Numbers  ICMJE YA-MSP-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wellspect HealthCare
Study Sponsor  ICMJE Wellspect HealthCare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Clare Fowler, Prof. University College, London
PRS Account Wellspect HealthCare
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP