Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Scler
Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- CIC using LoFric Primo
Given to everyone in the trial
- Anticholinergic medication
Results by group
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Baseline and 8 weeks after randomization.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| CIC Using LoFric Primo | -9.09 percent change | 27.82 (Standard Deviation) | 5 |
| Anticholinergic Medication | -6.41 percent change | 33.15 (Standard Deviation) | 3 |
CIC Using LoFric Primo
Anticholinergic Medication
p = 1.0000; Mean Difference (Net) 2
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| CIC Using LoFric Primo | 13 | 1 (7.7%) | |
| Anticholinergic Medication | 7 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
Baseline and 8 weeks after randomization.
Who could take part
MS (type not specified) · 18 and over
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Dec 2009
Main results due
May 2012
Finished
May 2012
Results posted
Jan 2014