None listed
Conditions
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.
Interventions
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 minu
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed