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

NCT00913510 | Terminated Results

• 1 other identifier: YA-MSP-0001
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 5

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

Conditions

Bladder Dysfunction; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

CIC using LoFric Primo

EXPERIMENTAL

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; Drug: Anticholinergic medication

Anticholinergic medication

ACTIVE COMPARATOR

Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.

Drug: Anticholinergic medication

Interventions

CIC using LoFric Primo DEVICE

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.

Also known as: LoFric Primo

CIC using LoFric Primo

Anticholinergic medication DRUG

Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.

Anticholinergic medication; CIC using LoFric Primo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (5)

Centre Hospitalier Universitaire de Liège Ourthe Ambléve

Esneux, 4130, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

St. Hedwig Hospital, Department of Urology

Berlin, 10115, Germany

Location

UMC ST Radboud Nijmegen, Department of Urology

Nijmegen, 6500 HB, Netherlands

Location

University College of London, Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dikran Shamoun
• Organization: Wellspect HealthCare

+46313764000

Study Officials

• Clare Fowler, Prof.

  University College, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 11, 2021
• Results First Posted: January 6, 2014

Record last verified: 2014-01

Locations

BE (2); GB (1); DE (1); NL (1)