The research question which needs to be answered is: Is it feasible to recruit in 6 months a minimal of 20 patients with MS and bladder dysfunction to participate in an acupuncture study and are these patients compliant with the treatment and theā¦
ID
Source
Brief title
Condition
- Demyelinating disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters for the feasibility of the study are:
- percentage of eligible patients that are willing to have electroacupuncture
- reasons for refusion to participate
- percentage of patients who are compliant with record keeping for the 3-day
bladder diary
- reasons for drop out during the study
Secondary outcome
Secondary outcome parameter relating to the effectiveness of the
electroacupuncture:
- patients' perceptions of improvement of their quality of life determined by
the I-QOL instruments.
- Reduction in the frequency of voiding, number of incontinent episodes,
severity of incontinence, number of nocturia episodes and urgency, over 3 days
determined by the 3-day bladder diary
- The severity of the incontinency will be measured in by the number of pads
used, (daily registering of number of pads)
Background summary
In patients with Multiple Sclerosis (MS), bladder dysfunction is a common
problem that affects up to 80% of the patients. Failure to store urine
(detrusor hyperreflexia) (DS), failure to empty urine (detrusor-sphincter
dyssynergia) (DSS) or a combined dysfunction leads to voiding dysfunction. The
complaints vary from an increased frequency to void, a desperate urgency to
empty the bladder and urinary leakage. The consequences are lowered self-image,
social isolation, loss of productivity and loss of quality of life.
Urine-retention can lead to an increased risk of urinary tract infection (UTI)
which can lead to a deterioration of the MS. Current treatment like
anticholinergic medication, behavioural therapy and physical therapy are
partially effective. Medication has substantial adverse effects like dry mouth
and often leads to a low compliance. Catheterisation, though effective, is at
the expense of quality of life. Intravesical electro stimulation is costly and
can have many complications like infection or battery failure with another
surgical intervention as consequence. Several studies have supported the
effectiveness electroacupuncture (electrical stimulation on acupuncture
needles) on voiding dysfunction. Tuzuner et al (1989) and Blorkstrom (2000)
treated children with enuresis nocturna with positive results. Furthermore,
electrical stimulation of the acupuncture point SP 6, known as percutaneous
tibial stimulation was effective with regard to the voiding dysfunction and the
quality of life. However, most of the studies included a heterogeneous group of
patients, including non-neurological bladder-dysfunction. This raises the
question what the effect will be in a homogenous group of patients with
neurological bladder dysfunction.
Study objective
The research question which needs to be answered is: Is it feasible to recruit
in 6 months a minimal of 20 patients with MS and bladder dysfunction to
participate in an acupuncture study and are these patients compliant with the
treatment and the primary outcome measurements?
Study design
The feasibility of the study will be evaluated by an observational study.
Study burden and risks
De burden consists of a screeningsvisit to the centre where a bladderscan will
be done and a urine study. Moreover, a questionnaire has to be filled in and a
bladder diary has to be registered during 3 days. It takes about 10 minutes to
fill in the questionnaire and about 15 minutes a day for the bladder diary.
Then, 1o treatments, once a week will take place at the practice of the
treating acupuncturist. 4 Neeldes will be placed in the legs and connected to a
electro-stimulation device. Sometimes, the neeldes can hurt a little or there
may occur a bruising. Treatment takes about half an hour. At the end of the
treatment the question3-day bladder diary has to be filled in again. The risks
of the acupuncture treatment are minimal.The practices (a total of one per
centre) are selected near by the centre so traveling time will be as short as
possible.
Heiweg 97
6533 PA Nijmegen
Nederland
Heiweg 97
6533 PA Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Patients with MS and voiding complaints during at least 6 months: greater than 8 voids per day, subjective urgency to void and urge-associated incontinence at least twice during a 3-day period of time.
Exclusion criteria
bladder infection at baseline, post voiding residual volume more than 100 ml, bladder complaints less than 6 months, a relapse less than 30 days before screening, complaints of spasms; pregnancy; sacral neurostimulator implanted, severe cardiopulmonary disease, unable to complete a 3-day voiding diary or the questionnaire.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17705.003.07 |