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

Wellspect HealthCare

Status: Terminated

Conditions: Multiple Sclerosis; Bladder Dysfunction

Treatments: Drug: Anticholinergic medication; Device: CIC using LoFric Primo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913510

YA-MSP-0001

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

CIC using LoFric Primo

Experimental group

Description:

Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device.

Treatment:

Device: CIC using LoFric Primo

Drug: Anticholinergic medication

Anticholinergic medication

Active Comparator group

Description:

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

Treatment:

Drug: Anticholinergic medication