[The elderly patient with urge incontinence or urge-stress incontinence - efficacy and cardiac safety of propiverine].
OBJECTIVE
The efficacy of propiverine in elderly patients suffering from urge incontinence or urge-stress incontinence was intended to be investigated. Especially in elderly patients a cardiac influence of propiverine is possible due to its dual mode of action. That is why besides the efficacy especially the cardiac safety was intended to be investigated.


METHODS
Ninety-eight patients (21 male, 77 female; 67.7 +/- 6.3 years of age) suffering from urgency, urge incontinence or mixed urge-stress incontinence were included in the double-blind, multicentre, placebo-controlled, randomized study. After a two-week placebo run-in period, the patients received propiverine (15 mg t. i. d.) or placebo (t. i. d.) for four weeks. Before (U 1, U 2) and during the treatment period (U 3, U 4), standard ECG's and 24 h long-term ECG's were recorded.


RESULTS
Propiverine caused a significant reduction in the micturition frequency (U 2 : 8.7 +/- 4.2, U 4 : 6.5 +/- 3.2 ml; p < 0.01) reflected in a significant increase in the average micturition volume (U 2 : 163.5 +/- 65.9, U 4 : 216.3 +/- 101.5 ml; p < 0.01) and a significant reduction in the episodes of incontinence (- 54 %; p < or = 0.05). These findings were confirmed by the overall assessment after four weeks in which approximately 90 % of patients under propiverine were either free from urge incontinence and urge symptoms or improved. The efficacy parameters demonstrated a better efficacy for urge incontinence than for mixed urge-stress incontinence. Resting and ambulatory electrocardiograms evidenced no significant changes. Neither QTc interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IV a/b) was fortuitous, revealing no difference between placebo and propiverine. The incidence of adverse events was very low (2 % dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires.


CONCLUSIONS
A favourable benefit-risk ratio in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence is therefore proven for propiverine. Cardiac arrhythmia were not induced.
Dorschner
W
W
Klinik und Poliklinik für Urologie, Universität Leipzig, Leipzig, Germany.
Stolzenburg
J-U
JU
Griebenow
R
R
Halaska
M
M
Brünjes
R
R
Frank
M
M
Wieners
F
F
D000367:Age Factors; D000368:Aged; D001561:Benzilates / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018680:Cholinergic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006321:Heart / Q000187:drug effects; D006801:Humans; D008297:Male; D010276:Parasympatholytics / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D010919:Placebos; D011788:Quality of Life; D012449:Safety; D011795:Surveys and Questionnaires; D013997:Time Factors; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000503:physiopathology; D014550:Urinary Incontinence, Stress / Q000188:drug therapy / Q000503:physiopathology; D014563:Urodynamics
D001561:Benzilates; D002121:Calcium Channel Blockers; D018680:Cholinergic Antagonists; D010276:Parasympatholytics; D010919:Placebos; C015586:propiverine