Bladder Dysfunction, Multiple Sclerosis
Conditions
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
Interventions
DEVICECIC using LoFric Primo
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.
Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Countries
Belgium, Germany, Netherlands, United Kingdom
Participant flow
Pre-assignment details
The study had a screening period between enrolment and randomization. Four (4) of the enroled patients were never randomized due to either withdrawal of consent or not fulfilling inclusion/exclusion criteria at randomization.
Participants by arm
| Arm | Count |
|---|---|
| CIC Using LoFric Primo Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device | 13 |
| Anticholinergic Medication Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. | 7 |
| Total | 20 |
Baseline characteristics
| Characteristic | CIC Using LoFric Primo | Anticholinergic Medication | Total |
|---|---|---|---|
| Age, Continuous | 41.15 years STANDARD_DEVIATION 12.86 | 51.71 years STANDARD_DEVIATION 8.34 | 44.85 years STANDARD_DEVIATION 12.38 |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 13 | 1 / 7 |
| serious Total, serious adverse events | 1 / 13 | 0 / 7 |
Outcome results
Primary
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%.
Time frame: Baseline and 8 weeks after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CIC Using LoFric Primo | Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. | -9.09 percent change | Standard Deviation 27.82 |
| Anticholinergic Medication | Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. | -6.41 percent change | Standard Deviation 33.15 |
Comparison: H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power.p-value: 1Wilcoxon (Mann-Whitney)