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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wellspect HealthCare
• Treatments: Cholinergic Antagonists

Criteria

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)