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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00913510
• Other study ID #: YA-MSP-0001
• Status: Terminated
• Phase: N/A
• Start date: December 2009
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Dysfunction
• Multiple Sclerosis
• Sclerosis

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire de Liège Ourthe Ambléve	Esneux
Belgium	UZ Gasthuisberg	Leuven
Germany	St. Hedwig Hospital, Department of Urology	Berlin
Netherlands	UMC ST Radboud Nijmegen, Department of Urology	Nijmegen
United Kingdom	University College of London, Institute of Neurology	London

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.