A randomised controlled trial: outcomes of bladder rehabilitation in persons with multiple sclerosis
- 1Department of Medicine, Dentistry and Health Sciences, University of Melbourne and Royal Melbourne Hospital, Melbourne, Victoria, Australia
- 2School of Rural Health, University of Melbourne, Shepparton, Victoria, Australia
- 3Biostatistics and Research Consultancy, Montrose, Victoria, Australia
- 4Clinical Epidemiology and Health Service Evaluation Unit, Melbourne Health and Centre for Research Excellence in Patient Safety, Monash University, Melbourne, Victoria, Australia
- 5Centre for Neuroscience, University of Melbourne, Parkville, Victoria, Australia
- Correspondence to Dr F Khan, Department of Medicine, Dentistry and Health Sciences, University of Melbourne and Royal Melbourne Hospital, 34-54 Poplar Road, Parkville, Melbourne, VIC 3052, Australia;
- Received 19 January 2010
- Revised 24 February 2010
- Accepted 25 March 2010
- Published Online First 11 June 2010
Objective A stratified, randomised, waitlist controlled study over 12 months assessed the effectiveness of a 6 week bladder rehabilitation programme in persons with multiple sclerosis (pwMS) in an Australian community cohort.
Methods Patients with definite MS and bladder issues (n=74) recruited from a tertiary hospital database were randomised to a treatment group (n=40) for an individualised bladder rehabilitation programme or to a control waitlist group (n=34). The Urogenital Distress Inventory (UDI6), Neurological Disability Scale (NDS) and the American Urological Association Symptom Index (AUA) assessed bladder impairment and ‘activity limitation’; a single Quality of life (QoL) item in the AUA and the Incontinence Impact Questionnaire (IIQ7) measured restriction in ‘participation’. Primary outcome measures were assessed at baseline and at 12 months.
Results Analysis of per protocol data from 58 patients (treatment n=24, control n=34) showed reduced disability in the treatment group, with significant differences (p<0.001) and large effect sizes (>0.5) in post-treatment UDI6, NDS, AUA total, AUA QoL and IIQ7 scores for the two groups. The treatment group compared with the control group showed improvement: 78% versus 27% for UDI6 and 59% versus 17% improved for IIQ7. More patients in the control group deteriorated over the study period on the UDI6 (30% vs 0%; p<0.001) and IIQ7 (39 vs 0%; p=0.001).
Conclusion A multifaceted, individualised bladder rehabilitation programme reduces disability and improves QoL in pwMS compared with no intervention after 12 months of follow-up. Information on specific interventions in different bladder types in MS and the impact on QoL need further evaluation.
Australian Clinical trials Registry ACTRNO12605000676617.
Linked articles 209866.
Competing interests None.
Ethics approval This study was conducted with the approval of the Human Research and Ethics Committees of the Royal Melbourne Hospital and the University of Melbourne.
Provenance and peer review Not commissioned; externally peer reviewed.