A randomized clinical trial of urinary incontinence in older women: cost-effectiveness of protocolized assessment and evidence-based treatment

Urinary incontinence is a very common health problem among women. 15%-55% of
older women report having experienced involuntary loss of urine. Consequences
of incontinence are social isolation, lack of self-confidence, shame and
depressive feelings. Urinary incontinence is undertreated. Treatment seeking is
often delayed and only 30%- 50% of the affected women ask for help. In most
general practices the identification and management of women with leakage of
urine is not actively pursuedThe condition can be effectively treated with
significant improvement of clinical and quality of life parameters. First line
effective treatments are behavioural interventions like pelvic floor muscle
training, bladder
training and correction of inadequate voiding patterns.
As urinary incontinence is associated with considerable costs favourable
economic effects may also be expected from a strategy that reduces the severity
ofincontinence. For this reason we propose a randomized clinical trial to
compare the cost-effectiveness of protocolized assessment and evidence-based
treatment as compared to usual care in elderly women
with urinary incontinence.

The study aims at delivering effective care for older women with urinary
incontinence. This condition is underdiagnosed and undertreated, though
effective treatments are available to manage urinary incontinence. Therefore,
it is important to study if a pro-active approach of the problem improves
symptoms and quality of life of elderly women and if this approach is
cost-effective.
The main research question is: what are the effects of a protocolized
assessment of urinary incontinence problems and an evidence-based treatment
advice by a multidiscplinary team on the severity of involuntary urine loss of
older women and on their quality of life, as compared to usual care, defined by
the NHG guideline.
A second question asks what costs are associated with urinary incontinence in
the usual care situation and what the costs and effects will be of the strategy
under study. Ultimately, we will answer the question: What are the effects of
this approach in terms of incremental cost-effectiveness of a protocolized
assessment of urinary incontinence problems and an evidence-based treatment
advice by a multidisciplinary team as compared to usual care as defined by the
NHG guideline? The primary outcome measure for the economic evaluation will be
the incremental costs per patient that experienced
improvement with regard to her urinary incontinence. Also the incremental costs
per QALY gained, and the incremental costs per additional day without urine
loss will be estimated.

The design of the study is a randomized clinical trial. To prevent
contamination, GPs will be randomized,
instead of patients. Based on degree of urbanization of the practice area and
age and sex of the GP,
matched pairs of GPs will be formed. Within each pair, a GP will be randomly
allocated to either
protocolized diagnosis and treatment or to usual care. The GPs in the control
group will be blinded for
the intervention protocol.
In the control practices, women will receive standard care, according to the
NHG guideline. In the
intervention practices, the results of the baseline assessment of each patient
will be reviewed during a
multidisciplinary meeting after which a treatment follows, targeted to the
patient. The follow up period is
12 months.

The intervention will consist of a protocolized assessment of urinary
incontinence and an evidence-based treatment, targeted to the patient. In the
control group, women will receive standard care.

The study does not imply any risks for the participants, as all investigations
are non-invasive. The burden of the study for the participants consists of
filling in questionnaires and keeping a three-day bladder diary. Patients from
the intervention group will have to visit the local study centre to have a
pelvic examination, including a uroflowmetry, stresstest and post void residu
measurement by ultrasound. After a diagnosis has been made, a treatment is
advised according to the current state of the art as formulated in the
professional protocols. These treatments are non-experimental and have proven
effectiveness. The majority of patients will be advised to visit a specialized
physiotherapist for pelvic floor muscle exercises and bladder training