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

Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis

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

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; Bladder Dysfunction
• Intervention / Treatment: Device: CIC using LoFric Primo; Drug: Anticholinergic medication

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Esneux, Belgium, 4130
    • Centre Hospitalier Universitaire de Liège Ourthe Ambléve
  • Leuven, Belgium, 3000
    • Uz Gasthuisberg
• Germany
  • Berlin, Germany, 10115
    • St. Hedwig Hospital, Department of Urology
• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • UMC ST Radboud Nijmegen, Department of Urology
• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • University College of London, Institute of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	Baseline and 8 weeks after randomization.

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Clare Fowler, Prof., University College, London

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Cholinergic Antagonists
• Other Study ID Numbers: YA-MSP-0001