Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Wellspect HealthCare
- Enrollment
- 24
- Locations
- 5
- Primary Endpoint
- Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: CIC using LoFric Primo (Device)
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.
Intervention: Anticholinergic medication (Drug)
Anticholinergic medication
Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
Intervention: Anticholinergic medication (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Time Frame: 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 Outcomes
No secondary outcomes reported