[The elderly patient with urge incontinence or urge-stress incontinence - efficacy and cardiac safety of propiverine].

Abstract

PURPOSE:

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.

MATERIAL AND 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.

• Authors: W Dorschner, J-U Stolzenburg, R Griebenow, M Halaska, R Brünjes, M Frank, F Wieners
• Journal: Aktuelle Urologie (Aktuelle Urol) Vol. 34 Issue 2 Pg. 102-8 (Mar 2003) ISSN: 0001-7868 [Print] Germany
• Vernacular Title: Der ältere Patient mit Drang-Symptomatik bzw. kombinierter Drang/Stress-Inkontinenz-Wirksamkeit und kardiale Sicherheit von Propiverin.
• PMID: 14566693 (Publication Type: Clinical Trial, Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Benzilates
• Calcium Channel Blockers
• Cholinergic Antagonists
• Parasympatholytics
• Placebos
• propiverine

Topics

• Age Factors
• Aged
• Benzilates (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Calcium Channel Blockers (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Cholinergic Antagonists (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Data Interpretation, Statistical
• Double-Blind Method
• Electrocardiography
• Female
• Heart (drug effects)
• Humans
• Male
• Parasympatholytics (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Placebos
• Quality of Life
• Safety
• Surveys and Questionnaires
• Time Factors
• Urinary Incontinence (drug therapy, physiopathology)
• Urinary Incontinence, Stress (drug therapy, physiopathology)
• Urodynamics