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

Study Overview
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Brief Summary
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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

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

Conditions
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Bladder Dysfunction, Multiple Sclerosis

Intervention / Treatment
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* Device: CIC using LoFric Primo
* Drug: Anticholinergic medication


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIC using LoFric Primo<br>Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device. | Device: CIC using LoFric Primo<br>* 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.<br>* Other names: LoFric Primo;Drug: Anticholinergic medication<br>* Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.<br>|
| Active Comparator: Anticholinergic medication<br>Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. | Drug: Anticholinergic medication<br>* Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |