Research Report Abstracts - Gesundheit

WPT2011, Research Report Abstracts eS147
incontinence score ≥12, and failure of conservative treatment,
including dietary measures and medication.
Methods: Consecutive patients (90% female; average age
59.3) were randomly assigned to receive rectal balloon training
as add-on therapy to pelvic floor muscle training (PFMT)
(group 1, n = 40) or PFMT alone (group 2, n = 40). Patients
took part in a 12-sessions pelvic physiotherapy program
during nine weeks. Treatment was evaluated objectively
with manometry, rectal sensory thresholds, anal and rectal
sensitivity tests post-intervention. Physiotherapy outcome
comprised the Oxford score and endurance and fatigue of the
external anal sphincter and pelvic floor. Subjective evaluation
included the Vaizey score (primary outcome), ranging
from 0 (complete continence) to 24 (complete incontinence),
the Wexner score, the 9-point global perceived effect score
and the Fecal Incontinence Quality of Life scale (FIQL). The
Medical Ethics Committee has approved the study.
Analysis: An intention-to-treat analysis was performed and
data were completed using the multiple imputation procedure.
Results: The mean Vaizey score reduced more in group
1 compared to group 2 (−4.5 vs −5.5, p = 0.43). Unlike
non-significant differences between groups on the primary
outcome, several observations show an enhanced therapeutic
effect from rectal balloon training: (1) significant increase in
maximal tolerable volume in group 1 compared to a decrease
in group 2 (p < 0.0), (2) significant higher subjective rating
of improvement in group 1 (p < 0.0), (3) the improvement
rate (Vaizey change score ≤−1) is higher (82.5% vs 76%) in
group 1, together with a higher reduction in Vaizey score (4)
paired samples analyses showed significant results for both
groups concerning primary outcome, Wexner score, subscale
‘Embarrassment’ of the FIQL scale, endurance and fatigue of
the external anal sphincter and pelvic floor, and the change
in Oxford-score of the pelvic floor. Group 1 showed additional
significant improvement in the remaining subscales of
the FIQL, urge sensation and maximal tolerable volume.
Conclusions: Rectal balloon training was not superior to
PFMT, although there are indications for an enhanced therapeutic
effect. Combined group analyses showed that pelvic
physiotherapy is effective, improving continence, subjective
relief, quality of life and anal sphincter function.
Implications: Pelvic physiotherapy should be offered before
proceeding to surgery in patients with moderate to severe
faecal incontinence. The add-on effect of rectal balloon training
and selection of patients who benefit most remains to
be confirmed in large well-designed randomized controlled
trials.
Keywords: Faecal incontinence; Pelvic physiotherapy; Rectal
balloon training
Funding acknowledgements: The study was supported by
Medeco BV, the Netherlands.
Ethics approval: The medical ethics committee of the University
Hospital Maastricht/Maastricht University approved
the study.
Research Report Poster Display
Number: RR-PO-308-13-Thu Thursday 23 June 13:00
RAI: Exhibit Halls2&3
OUTCOME MEASURES VALIDATION STUDY IN
DUCHENNE MUSCULAR DYSTROPHY PATIENTS
Bonfiglio S. 1 , Lerario A. 1 , Tettamanti A. 2 , Marktel S. 3 ,
Napolitano S. 3 , Previtali S. 4 , Scarlato M. 4 , Natalisora M. 4 ,
Bresolin N. 1 , Comi G. 4 , Gatti R. 2 , Ciceri F. 3 , Cossu G. 5 ,
Torrente Y. 1
1Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico,
Stem Cell Laboratory, Department of Neurological
Science, Centro Dino Ferrari, Milan, Italy, 2San Raffaele
Scientific Institute, Laboratory of Movement Analysis,
Milan, Italy, 3San Raffaele Scientific Institute, Pediatric
Immunohematology and Bone Marrow Trans, Milan, Italy,
4San Raffaele Scientific Institute, Division of Neuroscience,
Department of Neurology and INSPE, Milan, Italy, 5San Raffaele
Scientific Institute, Stem Cell Research Institute, San
Raffaele Hospital, Milan, Italy
Purpose: The aim of this study was to monitor the natural
history of the disease and to establish a reliable tool of
muscle strength assessment in Duchenne muscular dystrophy
(DMD) patients. We combined functional measures (North
Star Ambulatory Assessment and 6-minute walking test) and
quantitative assessments (Kincom 125 AP dynamometer) in
order to validate the quantitative muscular assessment with
the Kincom dynamometer and to correlate functional and
quantitative assessment.
Relevance: In a research setting is necessary to develop
outcomes measure that are clinically significant, but also sufficiently
sensitive and able to focus simultaneously on large
muscle groups or individual districts to detect even small
changes in the disease natural history or changes in muscle
strength which can guide researchers to proper therapeutic
strategies.
Participants: 28 DMD boys were selected on the basis of a
confirmed DMD diagnosis (i.e. clinical features, serum creatine
kinase, muscle biopsy and genetic analysis), age between
5 and 12 years old (mean 8.5 years), ability to ambulate at the
time of selection, absence of severe cardiac and pulmonary
disease. Quantitative data were compared to a cohort of 13
healthy aged matched male subjects. Parents of all included
subjects agreed and signed an informed consent.
Methods: This is a single centre, prospective, nonrandomised,
study of validation of outcome measures. We
perform two days evaluation each three month for one year.
During each assessment DMD patients performed North Star
Scale and 6 minute walking test during the first day; quantitative
assessment using the Kin Com 125 machine during the
second day. The muscle group tested with Kin Com were knee
extensors and knee flexors, through isometric and isokinetic
(20 ◦ /second) protocols, elbow flexors and extensors, through
isometric protocol. The controls subjects performed only the
quantitative assessment twice in a year.