Wake Up to Nocturia

Studies Reinforce Serious Associated Risk of Nocturia

BARCELONA, Spain, April 19, 2010 - Study results discussed today at the European Association of
Urology (EAU) Congress in Barcelona have reinforced the association between
nocturia and a greater risk of falls and mortality.

In a population-representative study in Japan by Nakagawa et
al , it was concluded that adults who suffered from nocturia (defined as two
or more episodes of voids/urination per night) had a significantly increased
risk of mortality when compared to adults without nocturia, even once
adjustments had been made for other contributing factors (e.g. age, gender,
physiological conditions).[1]

Furthermore, a community-based study by Parsons et al in 5,872
men aged 65 years or above, showed that in adults with moderate or severe
lower urinary tract symptoms (LUTS), the risk of having at least two falls
significantly increased when compared to those with mild LUTS symptoms.
Adults who endured 2-3 awakenings per night due to a need for voiding, had a
21% greater risk of at least two falls, while adults who endured 4-5
awakenings due to voids per night had a 63% greater risk.[2] Nocturia was
among the LUTS most strongly associated with falls.

"These studies have highlighted some vital new insights into
nocturia, primarily that it is a serious medical condition that should not be
dismissed as a lifestyle matter. The time has come for health providers and
the public to give nocturia the attention it deserves," comments Dr Raymond
Rosen from the New England Research Institutes, USA.

Several studies have demonstrated that prevalence of nocturia
is high with as many as 20% of adults aged 40-59 years thought to be
affected.[3,4,5] This increases to approximately 35% in those over 60
years old.[3] Nocturia repeatedly disrupts sleep and is associated with
multiple negative outcomes including a significant reduction in quality of
life and an increased morbidity.[6] Interrupted sleep caused by nocturia not
only affects the patient and their partners, but can also affect society
through reduced productivity and job performance.[7,8,9]

"The current lack of awareness about and understanding of
nocturia means this major problem often remains undiagnosed or
inappropriately treated," comments Professor Philip Van Kerrebroeck from the
University Hospital Maastricht, The Netherlands.

"In many cases, it is wrongly thought to be only a bladder or
prostate problem, when nocturia may actually be a kidney problem. We need a
two-pronged approach. Physicians need to recognise the signs and symptoms of
the condition and treat it appropriately, but patients also need to be aware
of the signs so they can go to their doctor as soon as they have any
concerns. It is important for patients to understand that their condition can
be treated and there is no need for them to suffer in silence".

Further investigative study will be required to establish
whether appropriate treatment of nocturia will help reduce the link between
the condition and other chronic diseases.

In an effort to raise awareness of nocturia as a condition in
its own right, it has newly been included within the official EAU guidelines.
The new chapter on non-neurogenic lower urinary tract symptoms (LUTS),
including nocturia, incorporates information on a variety of LUTS treatment
options including alpha-blockers and 5-alpha-reductase inhibitors. The
chapter also highlights the role of desmopressin as the only therapy
specifically addressing nocturia and its main cause nocturnal polyuria and
awards a Level 1 Grade A recommendation.[10]

About the studies

Association between nocturia and mortality in a
community-dwelling elderly population aged 70 years and over: results of a
3-year prospective cohort study in Japan (Nakagawa et al)

The authors conducted a Comprehensive Geriatric Assessment of
all residents aged greater than or equal to 70 years in 2003 in an urban
district of north Japan. The population-based cross-sectional survey was
conducted using an extensive health interview for each participant. Mortality
over 3 years was investigated using data from the national health insurance
system. Differences in survival stratified by presence/absence of nocturia
(greater than or equal to 2 voids/night) were assessed with Kaplan-Meier
curves, and statistical significance was calculated with the log-rank test.
The risk of mortality with or without nocturia was compared using a time
varying multivariate Cox proportional hazard model.

Lower urinary tract symptoms increase the risk of falls in older men
(Parsons et al)

The authors evaluated 5872 participants in the Osteoporotic Fractures in
Men, a prospective cohort study of risk factors for falls and osteoporotic
fractures among community-dwelling men aged > or =65 years. The primary
outcome was the 1-year cumulative incidence of falls in men with moderate or
severe, vs mild LUTS at baseline, as measured by the American Urological
Association Symptom Index. They used Poisson regression models and considered
multiple variables as potential confounders.

                                         2-3 voids/night      4-5 voids/night
    Relative risk of at least one fall         11%                 33%
                                             (RR 1.11,           (RR 1.33,
                                          95% CI, 1.01-1.22)   CI 1.15-1.53)

    Relative risk of at least two falls         21%                63%
                                             (RR 1.21,           (RR 1.63,
                                          CI, 1.05-1.40)       CI, 1.31-2.02)

    References

    [1] Nakagawa et al. J Urol 2009;181(Suppl):8
    [2] Parsons et al. BJU Int 2009;104:63-68
    [3] Irwin DE, Milsom I, Hunskaar S et al. Population-based survey of
        urinary incontinence, overactive bladder, and other lower urinary
        tract symptoms in five countries: results of the EPIC study. Eur
        Urol 2006; 50:1306-1315
    [4] Yoshimura K, Terada N, Matsui Y, Terai A, Kinukawa N, Arai Y.
        Prevalence of and risk factors for nocturia: Analysis of a health
        screening program. Int J Urol 2004;11: 282-287
    [5] Brieger GM, Yip SK, Hin LY, Chung TK. The prevalence of urinary
        dysfunction in Hong Kong Chinese women. Obstet Gynecol 1996; 88:
        1041-1044
    [6] Asplund R. Nocturia in relation to sleep, somatic diseases and
        medical treatment in the elderly 5. BJU Int 2002; 90: 533-536
    [7] Bolge SC, Doan JF, Kannan H, Baran RW. Association of insomnia with
        quality of life, work productivity, and activity impairment. Qual
        Life Res 2009; 18: 415-422
    [8] Bolge SC, Balkrishnan R, Kannan H, Seal B, Drake CL. Burden
        associated with chronic sleep maintenance insomnia characterized by
        nighttime awakenings among women with menopausal symptoms. Menopause
        2010; 17: 80-86
    [9] Kobelt G. Health-economic issues in nocturia. BJU Int 1999; 84 Suppl
        1: 29-32
    [10] European Association of Urology Guidelines - 2010 edition

For further information, please contact: Natalie Fairbank, Senior Account Executive, Tonic Life Communications, +44-207-798-9999, Natalie.Fairbank at toniclc.com; Jens-Peter Norgaard, Chief Scientific Officer, Medical Science Urology, Ferring Pharmaceuticals, +45-2878-7547, JensPeter.Norgaard at ferring.com