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

Not Applicable

Terminated

Interventions: Drug: Anticholinergic medication
Device: CIC using LoFric Primo

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

Recruitment & 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)

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.	Baseline and 8 weeks after randomization.	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%.

Secondary Outcome Measures

Name	Time	Method

Locations (5): St. Hedwig Hospital, Department of Urology
🇩🇪
Berlin, Germany
University College of London, Institute of Neurology
🇬🇧
London, United Kingdom
UMC ST Radboud Nijmegen, Department of Urology
🇳🇱
Nijmegen, Netherlands
UZ Gasthuisberg
🇧🇪
Leuven, Belgium
Centre Hospitalier Universitaire de Liège Ourthe Ambléve
🇧🇪
Esneux, Belgium