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

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)