Neurourology and urea
`VI 20' no. 4
`)
`General Collection
`W1 NE3495|v|
`2001-08-06 07:19:19
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`Ynamics.(|M)
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`ROUROLOGY
`URODYNAMICS
`
`Volume 20, Number 4, 2001
`
`PROCEEDINGS OF THE
`
`INTERNATIONAL CONTINENCE SOCIETY
`
`3 IST ANNUAL. MEETING
`
`SEOUL, KOREA
`
`.1 8-2 I Sl'iI’TEMB1iR 200]
`
`.._
`@WILEY"LISS
`
`ISSN 0733-2467
`
`
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`Patent’0wnIeIr, UCB Pharma GmbH — Exhibit 2064 - 0001
`
`

`
`EUROUROLOGY
`
`AND
`
`URODYNAMICS
`
`______A___ <_
`
`F.l)lT()R-IN-CI-[IE]? __j_ T __
`Jerry G. lllaivas, M.D.
`Clinical Pl'()i'i:s5ur of Urology
`Curucll University Medical School
`ALl¢l:'cssjmIrnnl COl‘1'c.S]‘JDl1(lCllCl.‘. lo:
`400 East 50th Slrcet - New York. NY 10021. USA
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`l)El’U'l'Y El)l'l'0RS
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`Mcdlunl Center
`I-’hil;1dclpl1iu. PA, USA
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`The Official Journal of
`
`International Continence
`Society
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`Society for Urodvnamics
`& Female Urology
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`Ulnyriulu ‘:2 2001 \’VilL-y-I,iM, Inc.
`
`This journal is printed on acid-free paper.
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2064 - 0002
`
`

`
`International Continence Society
`
`3 1“ Annual Meeting
`
`Seoul, Korea
`18*“ — 215‘ September 2001
`
`Chair—Prof Kwan M un Kim
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2064 - 0003
`
`

`
`Conclusions:
`
`The bladder selectivity of tolterodine IR when compared to oxybutynin IR extends to the once-daily
`
`formulation of these products. Tolterodine once-daily has selectivity for the bladder versus salivation white
`Dltropan XL has an overall greater effect on salivation than on the bladder.
`
`Abstracts 406
`
`References:
`
`1) Nilvebrant L, et al. EurJ Pharmacol. 1997; 327: 195-207.
`
`2) Appell RA, Urology 1997; 50 (6A Suppl.): 90-96
`
`3) Abrams P, et al. Br J Urol 1998; 81: 801-810
`
`4) Drutz H. et al. Int Urogynecol J Pelvic Floor Dysfunct 1999; 10: 283-289
`
`Supported by Pharmacia Corporation
`
`24
`
`Authors:
`
`Institution:
`
`Title:
`
`Aim of Study:
`
`(2) R. Herzog (3) A. Wein (4) P. Abrams (5) C. Payne (6) R. Corey (T) T.
`(1) W. Stewart
`Hunt (8) NOBLE Program Research Team
`(1) Innovation Health So|utions,(2) University of Michigan,(3) University of Pennsylvania
`(4) Bristol Urological lnstitute,(5) Stanford University,(6) Philadelphia College of Pharmacy
`(6), (7) Pharmacia Corporation
`PREVALENCE AND IMPACT OF OVERACTIVE BLADDER IN THE US: RESULTS FROM
`THE NOBLE PROGRAM
`
`Overactive bladder (OAB) is a common problem affecting millions of people in the US. There are no reliable
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`data as to the prevalence and burden of illness of this condition. Although OAB is an inclusive term
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`describing the population of patients suffering from urinary urgency and frequency with or without urge
`incontinence, there are no data at all as to the clinical significance and impact of OAB without incontinence
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`(OAB Dry) as compared with individuals with incontinence (OAB Wet). In addition. although OAB is easily
`understood clinically,
`there is no agreed objective definition for research use. The National Overactive
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`BLadder Evaluation (NOBLE) Program was conducted to provide a clinically valid research definition of
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`OAB, then to establish estimates of its overall prevalence, the individual burden of illness. and to explore
`differences between the OAB Wet and OAB Dry populations.
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2064 - 0004
`
`

`
`Abstracts 407
`
`Methods:
`
`A computer assisted telephone interview (CAT!) was developed to estimate variation in prevalence of OAB
`
`by demographic and other factors. The CATI was assessed for reliability and clinical validity. Clinical
`validity of the CATI was assessed in a Baltimore-based community sample, where the CAT! diagnosis was
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`compared to a clinician's diagnosis. The sensitivity and specificity of the CATI for OAB were 61% and 91%,
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`respectively. As previously reported, the CATI was proven reliable [1]. The validated US national telephone
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`survey used a quota sampling method to select 5.204 English-speaking adults (218 years of age)
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`representative of the US non—institutionalized population with regard to gender, age, and geographic region.
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`OAB Dry was defined .24 episodes of urgency in the preceding 4 weeks, and either frequency more than 8
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`voids/day or the use of one or more coping behaviors to control bladder tunction. OAB Wet included the
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`same criteria as OAB Dry plus 23 episodes of urinary incontinence in the past 4 weeks that could not be
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`explained by stress symptoms. During the CAT}, participants were asked questions about bladder
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`symptoms and coping behaviors. To assess illness impact, OAB cases and matched controls from the
`national survey completed self-administered questionnaires on quality of life (SF-36), quality of sleep (MOS
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`Sleep), and depression status (CES-D questionnaire).
`
`Results:
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`The overall prevalence of OAB was 16.9% in women and 16.0% in men, increasing with age. The overall
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`prevalence of OAB Dry and OAB Wet was 7.6% and 9.3% in women, respectively, and 13.6% and 2.6%,
`
`respectively, in men. Quality of life and symptom data were collected on 215 OAB Dry and 184 OAB Wet
`cases and 512 matched controls. After adjusting for differences in comorbid illnesses (ie, congestive heart
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`failure, diabetes, selected neurological diseases, and cancer) and other demographic factors, OAB Wet and
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`Dry cases in women and men had Clinically and significantly lower quality of life (SF-36 subscores), lower
`depression status (higher CES-D depression scores), and poorer quality of sleep (higher MOS sleep
`
`scores). For many of the measures, OAB Dry was similar to OAB Wet (Table).
`
`Mean scores (SE) in measures of QoL (SF-36, depression, and sleep)
`between OAB cases and age-matched controls
`
` 39.3 (1.2)*'*
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`"Outcome
`
`SF-36 "
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`SF-36
`
`--Physical Health Summary Score
`
`--Mental Health Summary Score
`
`L
`
`5l:Z§:D (overall score)
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`‘ MOS Sleep (mean)
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`49.4 (0.6)
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`45.3 (1.4)"'
`
`49.8 (0.7)
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`46.3 (1.0)'*
`
`49.7 (0.6)
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`45.1 (1.4)~
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`53.6 (0.6)
`
`49.3 (0.9)'**
`
`11.77076)
`7.4 (0.6)
`
`17.3 (1.'6)"*
`13.0 (0.9)***
`
`25.4 (0.9)
`
`35.4(2.4)*--
`
`20.1(1.1)
`
`27.5(1.5)**-
`
`
`
`41.3 (1.0)***
`
`46.8 (1 .0)‘
`
`47.7 {1.9)“"'
`
`1T.1(1.1)“*
`
`16.7 (1.8)"‘
`
`36.5 (1 .a)***
`32.9 (2.8)“'
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2064 - 0005
`
`

`
`r\l)str:1cts 408
`
`W = women; M = men ‘p < 0.05; '* p < 0.01: **"p < 0.005
`Conclusions:
`
`We present the first validated and reliable data on the prevalence of OAB in the US, demonstrating that
`16% of both men and women suffer with the condition. For the first time we have shown that OAB has a
`
`substantial individual impact, even among those without incontinence. Clinically and statisticaliy significant
`
`differences in quality of life, mental health, and quality of sleep are revealed. Differences remain significant
`
`after adjusting for other comorbid illnesses and stress incontinence symptoms. We have established a
`statistically rigorous objective definition of OAB that can be used in future research and clinical trials.
`Reference:
`
`1. Stewart W, Payne C, Herzog R, Norton P. Reliability of reporting on symptoms and features of overactive
`
`bladder in a community sample. Presented at
`Tampere Finland. 2000, abstract 30?.
`
`Project sponsored by Pharmacia Corporation.
`
`International Continence Society 30"‘ Annual meeting,
`
`25
`
`Tung-pung Chou, Liang—Shyng Nieh, * Kuang-Ho Chen
`Authors:
`Institution: DEPARTMENT OF OBSTETRICS & GYNECOLOGY ARMED FORCE GENERAL
`HOSPITAL
`‘INSTITUTE OF EPIDEMIOLOGY, COLLEGE OF PUBLIC HEALTH,
`DEPARTMENT OF LABORATORY MEDICINE, COLLEGE OF MEDICINE, NATIONAL
`TAIWAN UNIVERSITY
`ACUPUNCTURE 8: MOXIBUSTION FOR WOMEN WITH SYMPTOMATIC VOIDING
`DIFFICULTIES A PRELIMINARY REPORT
`
`Title:
`
`Aims of Study:
`
`Much attention focused on voiding difficulty in women has been paid recently. Although debates in
`
`diagnosing standardized monogram exist, the goal of treatment i.e. anatomic correction and functional
`
`restoration are almost consistent. However, the impacts of surgery. reoperation and for unsatisfactory with
`
`medication on voiding dyslunction are progressively increasing. An alternative approach including
`traditional Chinese medicine ( TCM )
`in the treatment of lower urinary tract dysfunction with a good
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`response in the relief or improvement of irritable symptoms in women are reported. Acupuncture &
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`moxibustion { acumoxa )
`
`, an important part of TCM, in the clinical trial for the obstructive symptoms was
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`stili scarce and to be explored. Fortunately, acumoxa is popular and easier to be accepted as a regimen in
`
`Taiwan. Therefore, we tried to investigate the therapeutic potential of acupuncture 8. moxibustion in the
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`treatment of women with symptomatic voiding difficulties.
`Methods:
`
`During a period of 2 years, all consecutive women attending for lower urinary tract symptoms ( LUTS)
`evaluation completed a thorough history-taking, urinalysis, physical examination and free uroflowrnetry.
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`Patients fulfilled the following criteria were enrolled. Firstly, had 2 or more of symptoms of voiding difficulty
`such as strain to void, poor stream, incomplete voiding or frequency. Secondly, voided into a gravirnetric
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`flowmeter ( microflo 2001 N, Life-Tech Inc, USA }
`
`in the circumstances of comfortable full bladder in
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`privacy with Qmax 5 the 10"‘ centile of the Liverpool nomogram chart for women [1]. Thirdly, repeated the
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2064 - 0006