`
`Abstract 187
`
`‘
`
`
`
`Madersbacher H1, Halaska M2, Voigt R3, Alloussi Sh4. Hdffier K5
`
`Univ.aH0spital Innsbruckl, Prague2, Jenad, HombuI'g4, Hannovers
`
`A URODYNAMICALLY CONTROLLED MULTICENTER STUDY IN PATIENTS WITH
`URGE INCONTINENCE: TOLERABILITY AND EFFICACY OF PROPIVERINE
`HYDROCHLORIDE IN COMPARISON TO OXYBUTYNIN
`
`in
`and efficacy (2) of propiverine (prop.)
`AIMS OF STUDY: The tolerability (1)
`patients with urge incontinence was studied in comparison to oxybutynin {oxy.}
`
`and placebo
`study.
`
`(plac.)
`
`in a
`
`randomized double—blind, urodynamically controlled
`
`METHODS AND MATERIAL: 366 patients (prop. n=149: oxy. n:14S; plac. n=72:
`
`ratio
`
`study centers.
`recruited in 32
`suffering fronx urge incontinence were
`2:2:1)
`Dosages of
`15 mg prop.
`t.i.d.,
`5 mg oxy. b.i.d. or plac. were administered
`according to randomisation for
`4 weeks. Double—dummy—technique
`for medication
`guaranteed double—blind study conditions.
`
`(1) Tolerability was assessed by directly questioning the patients for adverse
`events at
`4 visits (V-1; V0, V1, V4) during a 4-weeks surveillance period and by
`
`documentation of the tolerahility ratings of the physicians.
`(2) Efficacy was assessed (a) by urodynamics before and after 4 weeks treatment
`
`(V0-V4]
`
`evaluating cystometric bladder capacity at maximal desire to void,
`
`Cystometric bladder capacity at first desire to void and detrusor pressure at
`
`first desire to void, according to ICS criteria. Additionally,
`
`{b}
`
`subjective
`
`data as the urge score of Gaudenz incontinence questionnaire, global assessment
`of clinical improvement and efficacy ratings by the physicians were documented.
`
`RESULTS:
`
`(1) Tolerahility: A high percentage of adverse events was
`
`reported already in
`
`the wash—out period (VG: prop.
`
`13 %;
`
`oxy.
`
`16 %; plac.
`
`18 %), at
`
`the final
`
`evaluation {V4)
`
`the clinically Inost
`
`relevant
`
`symptom, dryness of
`
`the mouth,
`
`in 66.9 % with cxy. and in 27.8 % with plac. Prop.
`occured in 53.4 % with prop.,
`revealed an increasing tolerability during the course of treatment
`(Vl~V4). The
`
`adverse events under prop., compared to oxy., were of
`
`lower severeness.
`
`67 % of
`
`patients with prop., 59 % with oxy. and B3
`
`% with plac. stated a "very good“ or
`
`“good” tolerability.
`
`(2) Efficacy: Urodynamics proved a statistically significant
`
`increase of
`
`the
`
`maximal cystometric bladder capacity for prop.
`
`(V0:
`
`222 i 77 ml; V4: 311 t 125
`
`ml;
`
`increase by 89
`
`i
`
`108 ml)
`
`in comparison to plac.
`
`(Mann-Whitney U-Test,
`
`p=U.005} as well as for oxy.
`
`(V0: 226 i 75 ml; V4 322 i 123 ml;
`
`increase by 96 i
`
`106 ml)
`
`in comparison to plac.
`
`(Mann-Whitney U-Test, p=0.002). The plac. group
`
`-153-
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2038 - 0001
`
`

`

`
`
`Abstract 187 continued
`
`
`
`demonstrated only minor, non significant change (V0: 211 i 77 ml; V4: 263 i 93
`
`increase by 52 :t 92 ml) . The cystometric bladder Capacity at first desire to
`ml;
`void increased statistically significant with prop.
`(V0:
`93 ml, V4: 160 ml]
`and
`
`oxy.
`
`{V0 89 ml: V4 160 ml) whereas plac.
`
`increased non-significantly (V0 93 ml:
`
`the objective urodynamic parameters were
`of
`improvements
`The
`120 ml).
`V4
`comparable for both Vera. Detrusor pressure at first desire to void showed no
`
`significant difference between
`
`the
`
`three
`
`treatment
`
`groups. Alterations
`
`of
`
`residual urine within and between the treatment groups were only nunimal and
`
`clinically not relevant.
`
`(3) Subjective data: the urge score of Gaudence incontinence questionnaire (prop.
`
`V0: 14.1, V4: 5.8; oxy: 14.7, V4: 6.1; plac. V0: 14.1, V4: 6.8) global assessment
`of clinical
`symptomatology (improvement
`in 83.3 % with prop.,
`in 79.3 % with
`
`oxy,
`
`in 68.3 % with plac.)
`
`and efficacy ratings by the physicians
`
`(,,excellent‘‘
`
`or ”good“ results in 65.9 % for prop.,
`
`in 67.6 % for oxy.,
`
`in 52.4 % for plac”
`
`for prop.,
`”satisfactory“ results in 16.7 %
`plac.} supported the urodynamic results.
`
`in 12.4 %
`
`for oxy.,
`
`in 7.9 % for
`
`CONCLUSIONS: Prop. proved to be a safe and comparatively well tolerated drug in
`
`an anxious patient population documenting a high percentage of adverse events
`
`in patients with urge
`prior to the beginning of the study. The efficacy of prep.
`incontinence
`is
`comparable
`to
`oxy.
`The
`availibility of
`a
`spectrum of
`
`pharmacotherapeutic options
`
`including prop.
`
`reduces
`
`therapeutic failures and
`
`improves the success rates in this group of patients.
`
`-154-
`
`Patent Owner, UCB Pharma GmbH — Exhibit 2038 - 0002
`
`