ICS 1999, Denver
Informally discussed posters
Urodynamics
No differences in the efficacy and tolerability of propiverine-hydrochloride in geriatric and older age patients compared to adults

J. Siegert, T. Gramatté, F. Schnabel¹, G. Schubert2
Medical Research; Biostatistics Department¹; Medical Affairs Division²; APOGEPHA Arzneimittel GmbH, Dresden, Gemany

Aims of study: Data for efficacy and tolerance of propiverine hydrochloride for the treatment of incontinence, urgency and enuresis were recorded in an open international multicentre trial (post marketing surveillance) in approx. 4500 patients. In this trial 901 patients in the age group 65 to 74 years and 478 patients 75 and older than 74 years were included.

The data of these subpopulations were analysed and compared with the results obtained for adults (age 18-64).

Methods: Efficacy (frequency of incontinence episodes, urgency, number of micturitions an pad use), and tolerability (heart rate, blood pressure and adverse events) were judged prior to and after 4 and 12 weeks of treatment. In addition demographic and anamnestic data, diagnosis, concomitant disease and therapy, and previous therapy were recorded for each patient.

Results: The diagnosis was in the geriatric population urge-incontinence 38.4%, mixed-incontinence 35.9%, urge-symptoms 17.4% and postoperative use 7.4% in the older age group the diagnoses were urge-incontinence 45.7%, mixed-incontinence 33.3%, urge symptoms 17.4% and postoperative use 2.9% whereas in the adult group diagnoses were urge-incontinence 31.9%, mixed-incontinence 39.0%, urge-symptoms 23.4% and postoperative use 3.4%.

Geriatric patients older age patients adults
(65 - 74 years) (75+ years) (18-64 years)
Number of patients included 901 478 2369
Age (mean) years 69.6 80.2 50.0
Body weight (mean) kg 74.6 69.8 70.7
Daily dose propiverine HCI (mean) mg 36.4 35.7 36.4
1^st week
Male / female patients (%) 23.8 / 76.2 26.2 / 73.8 10.7 / 89.3
Number of day time micturitions (mean) 9.4 / 6.7 / 5.9 9.3 / 6.8 / 6.0 9.3 / 6.6 / 5.7
weeks 0 / 4 / 12
Number of night time micturitions (mean) 3.1 / / 1.7 / 1.2 3.4 / 2.1 / 1.6 2.5 / 1.3 / 0.9
weeks 0 / 4 / 12
Day time mean incontinence episodes 4.0 / 1.9 / 1.2 4.3 / 2.4 / 1.5 3.5 / 1.8 / 1.0
weeks 0 / 4 / 12
Wet or soaking wet pad (% of patients), 64.7 / 38.7 / 27.5 65.7 / 45.6 / 30.5 58.2 / 38.3 / 21.9
weeks 0 / 4 / 12
Reporting of dry mouth (% of patients), 22.7 / 55.1 / 42.6 25.1 / 52.1 / 42.7 18.4 / 54.1 / 41.0
weeks 0 / 4 / 12
Reporting of accommodation disorder 8.3 / 17.7 / 11.1 10.5 / 17.1 / 12.3 6.6 / 18.6 / 10.8
(% of patients), weeks 0 / 4 / 12
Reporting of tiredness (% of patients), 21.9 / 22.8 / 17.2 27.2 / 28.7 / 21.5 19.5 / 24.1 / 16.4
Weeks 0 / 4 / 12
Termination due to vanished symptoms/ 12.8 / 4.6 7.9 / 5.6 16.2 / 3.5
Insufficient efficacy (%)

Heart rate and blood pressure showed no changes over time. The residual urine (mean) decreased from 23.2 ml (week 0) to 15.3 ml (week 12) in the geriatric group and from 23.0 ml to 17.0 ml in the older age group.

There is similar efficacy and tolerability as well as frequencies of different forms of incontinence in the three groups of age compared.

Conclusion: Propiverine hydrochloride is an effective and well tolerated drug to treat incontinence and urge-symptoms in elderly patients.