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Trial registered on ANZCTR


Registration number
ACTRN12612000471886
Ethics application status
Not yet submitted
Date submitted
21/04/2012
Date registered
30/04/2012
Date last updated
30/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does treatment initiated by a Continence Nurse help to improve bladder and bowel problems in people with Multiple Sclerosis?
Scientific title
Randomised Controlled Trial to determine whether nurse-initiated management improves bladder function in people with Multiple Sclerosis.
Secondary ID [1] 280369 0
Nil
Universal Trial Number (UTN)
U1111-1130-1257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder dysfunction 286352 0
Multiple Sclerosis 286353 0
Quality of life related to degree of bother and impact on life 286354 0
Condition category
Condition code
Neurological 286589 286589 0 0
Multiple sclerosis
Renal and Urogenital 286593 286593 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be screened with a newly developed continence screening tool. This tool has been trialed as part of a pilot study, and will be refined further by trialing on 50 people with MS, before it is further refined and then re-trialed by two Neurologists and two MS Nurses on ten patients with MS. The final version will then be drafted.

The continence screening tool will be administered by the Continence Nurse for the RCT. It is a one-page double-sided form which will take 5-10 minutes to complete. A 5-point scale is used for all questions. Urinary questions pertain to frequency, urgency, intemittency, straining, feeling of emptyness, use of catheter, urinary tract infection, incontinence, near-miss incontinence, fluid intake. Bowel questions pertain to frequency, consistency using the Bristol Stool Scale, urgency, straining incomplete emptying, need to manually evacuate, faecal incontinence and near miss situations relating to faecal incontinence.

The two quality of life questions include a four point scale relating to the degree to which bladder and bowel symptoms interfere with life, and a seven point scale relating to how the individual would feel if they had to spend the rest of their life with current level of bladder and bowel symptoms. There are separate questions for each; a total of four questions.

All participants will be screened with the continence-screening tool, and if symptomatic (determined by their continence-screen score), will be allocated to one of two study arms. This is the screening visit.

ARM 1 (Treatment Group): On the second visit, this group of MS participants will have a more thorough continence assessment and have a management plan outlined by the Continence Nurse. Follow up will occur at 1, 3(by phone), 6 and 12 months following the initiation of continence intervention. Intervention follows standard practice, based upon current best-practice guidelines. This will also involve working closely with the patient's Neurologist and referral to a Medical Clinical Mentor and Continence Physician, as required. Outcome measures include urinary symptoms and quality of life related to burden and impact.

ARM 2 (Control Group): This group of MS participants will be provided reference material in the form of pamphlets, articles and booklets provided and endorsed by the Continence Foundation of Australia which will be tailored to that individual's particular problems. It is up to the individual's own discretion as to how they use this information. This group will also continue to be managed by their regular health care team including their Neurologist, MS Nurse and General Practitioner (GP). Participants in this arm will be reviewed 6 months after re-screening with the continence-screening tool. Patients with persistent symptoms will be offered treatment as per ARM 1.
Intervention code [1] 284739 0
Treatment: Other
Intervention code [2] 284774 0
Early detection / Screening
Comparator / control treatment
ARM 1: Standard continence intervention which has been initiated by a Continence Nurse

ARM 2: Package of information tailored to the participant's continence issues, plus standard care from the participant's health care team eg Neurologist, MS Nurse or GP
Control group
Active

Outcomes
Primary outcome [1] 287010 0
Bladder function symptom score. Measuring the following symptoms for improvement: UTI, urinary urgency, urinary hesitancy, urinary intermittency, urinary straining, feeling of incomplete emptying and urinary incontinence.

A screening tool, to assess the above-mentioned symptoms, and determine a bladder function symptom score has been trialed and will be refined prior to commencement of randomised control trial. The tool has been based upon the American Urological Association (AUA) Symptom Index
Timepoint [1] 287010 0
Following intervention, measurement of bladder function will occur at 1, 3(by phone), 6 and 12 months.
Secondary outcome [1] 297195 0
Quality of life measures related to degree of bother and impact of urinary symptoms on life. The Quality of Life question is part of the American Urological Association (AUA) Symptom Index
Timepoint [1] 297195 0
Following intervention, measurement will occur at 1,3,6 and 12 months

Eligibility
Key inclusion criteria
Confirmed diagnosis of Multiple Sclerosis.
Able to read English sufficiently to comprehend the study requirements and give informed consent.
Participants with MS attending the Box Hill Hospital MS outpatient clinic.
Willing to undergo serial continence evaluation over a period of 12 months
A score of 10 or more on the Bladder symptom score
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years of age.
No definitive diagnosis of Multiple Sclerosis.
Insufficient English literacy to understand the study information.
Unwilling to give consent to the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients attending the Eastern Health MS Service, Box Hill Hospital in Melbourne Vicoria, Outpatients Service each week will be asked if they would like to participate in the randomised controlled trial. All patients who agree to be screened and are identified with a continence issue, using the continence screening tool, will be randomly allocated to to one of two arms.

The following process will occur:
1. A randomisation administrator not involved in the trial and working at a different institution will generate a random sequence of numbers Group 1 and Group 2 using http://www.randomizer.org/form.htm
2. The Continence Nurse will screen all patients
3. The MS Nurse, who is not involved in the trial and who also attends the MS Outpatients Clinic where screening will occur, will allocate the screened patients to either arms of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated process using http://randomizer.org/form.htm will be used to generate numbers 1 and 2 to correspond with the two treatment arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
ARM 1 will receive standard continence care, initiated by a Continence Nurse working in the Eastern HealthMS Service

ARM 2 will receive literature and resource information, including referral information. They will also be provided standard care by their MS health care team. At the end of 6 months they will be rescreened, and if they still have continence issues they will be offered care as per protocol in ARM 1
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285147 0
University
Name [1] 285147 0
Eastern Clinical Research Unit, Eastern Health MS Service is part of the Monash University, located at the Box Hill Hospital Campus of Eastern Health.
Country [1] 285147 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Eastern Clinical Research Unit
Level 2
5 Arnold Street
Box Hill, VIC. 3128
Country
Australia
Secondary sponsor category [1] 284010 0
Hospital
Name [1] 284010 0
Eastern Health Service, Box Hill Hospital
Address [1] 284010 0
Nelson Road
Box Hill, VIC., 3128
Country [1] 284010 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287160 0
Eastern Health Ethics Committee
Ethics committee address [1] 287160 0
Level 2
5 Arnold Street
Box Hill, VIC., 3128
Ethics committee country [1] 287160 0
Australia
Date submitted for ethics approval [1] 287160 0
24/04/2012
Approval date [1] 287160 0
Ethics approval number [1] 287160 0

Summary
Brief summary
Bladder dysfunction in people with Multiple Sclerosis is very common, very distressing and can affect the individual’s quality of life in many ways. Although it is strongly recommended that routine, targeted continence assessment be undertaken, this is poorly done by health professionals and inadequately discussed by patients. By appropriate screening and targeted continence treatment, initiated by a Continence Nurse, it is hoped that symptoms and quality of life will improve. This will be undertaken by comparing two groups of patients with identifiable continence problems, using a simple one page, double sided continence-screening tool, administered by the Continence Nurse. Participants in Group 1 will be offered assessment and management in line with standard continence practice by the Continence Nurse. Follow up will occur at 1, 3(by phone), 6 and 12 months. Participants in Group 2 will be offered standard care by the patient’s Health Care Team and tailored information endorsed by the Continence Foundation of Australia. The patients in Group 2 will subsequently be reviewed by the Continence Nurse following 6 months, and offered treatment as per the patients in Group 1, if symptoms persist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34098 0
Address 34098 0
Country 34098 0
Phone 34098 0
Fax 34098 0
Email 34098 0
Contact person for public queries
Name 17345 0
Louise Kurczycki
Address 17345 0
Level 2
5 Arnold Street
Box Hill, VIC., 3128
Country 17345 0
Australia
Phone 17345 0
+61429205127
Fax 17345 0
+61398999137
Email 17345 0
[email protected]
Contact person for scientific queries
Name 8273 0
Assoc Prof Helmut Butzkueven
Address 8273 0
Department of Neurology,
Level 4
Royal Melbourne Hospital, city Campus
Grattan Street
Parkville, VIC., 3050
Country 8273 0
Australia
Phone 8273 0
+61414881494
Fax 8273 0
+61398999137
Email 8273 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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