Bladder DysfunctionNCT00913510
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
A study testing CIC using LoFric Primo and Anticholinergic medication in people with Bladder Dysfunction and Multiple Sclerosis, run by Wellspect HealthCare at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Dysfunction, Multiple Sclerosis
- What is being tested?
- CIC using LoFric Primo and Anticholinergic medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Dec 2009to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Belgium2 sites
Centre Hospitalier Universitaire de Liège Ourthe Ambléve
Esneux, 4130
UZ Gasthuisberg
Leuven, 3000
Netherlands1 site
UMC ST Radboud Nijmegen, Department of Urology
Nijmegen, 6500 HB
United Kingdom1 site
University College of London, Institute of Neurology
London, WC1N 3BG
About this study
Official title: Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
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
- Conditions
- Bladder Dysfunction, Multiple Sclerosis
- Being tested
- CIC using LoFric Primo, Anticholinergic medication
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIC using LoFric PrimoDevice
Also called 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 medicationDrug
Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.
| Study group | Role | What they receive |
|---|---|---|
| CIC using LoFric Primo | Experimental | Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device. Receives: Device: CIC using LoFric Primo; Drug: Anticholinergic medication |
| Anticholinergic medication | Active comparator | Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. Receives: Drug: Anticholinergic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline and 8 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clare Fowler, Prof., Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913510
- Sponsor's protocol ID
- YA-MSP-0001
- Status last verified
- Jan 2014
- First submitted
- 3 Jun 2009
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00913510
- Acronym / sponsor ID
- YA-MSP-0001
- Conditions
- Bladder Dysfunction, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 6 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIC using LoFric Primo | Experimental | Device: CIC using LoFric Primo, Drug: Anticholinergic medicationAnticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device. |
| Anticholinergic medication | Active comparator | Drug: Anticholinergic medicationAnticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIC using LoFric PrimoAlso: LoFric PrimoAnticholinergic 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. | Device | CIC using LoFric Primo |
| Anticholinergic medicationAnticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug. | Drug | Anticholinergic medication, CIC using LoFric Primo |
Primary outcome
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%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Fowler, Prof. principal investigator
University College, London
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIC using LoFric Primo and Anticholinergic medication in people with Bladder Dysfunction and Multiple Sclerosis, run by Wellspect HealthCare at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks. (time frame: Baseline and 8 weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.