Evaluation of long-term safety and clinical benefit of terodiline in women with urgency/urge incontinence. A multicentre study.
Terodiline is a secondary amine with anticholinergic and calcium antagonistic properties. The drug has been shown in controlled studies to be effective in patients with motor urge incontinence. In order to evaluate safety and clinical benefits of terodiline during long-term therapy in women with urgency/urge incontinence, a 6-month study has been performed. The study was designed as an open multicentre study with a run-in period and assessments after 3 and 6 months treatment. One hundred patients with a mean age of 48 years (range 18-78) were included. The daily dose was 50 mg, given as 25 mg in the morning and 25 mg at night. The safety was evaluated by recording of adverse reactions and measurements of haematology (B-Hb, B-erythrocytes, B-leukocytes, B-thrombocytes), liver function (S-ALAT, S-ASAT, S-ALP), kidney function (S-creatinine), ESR, heart rate and blood pressure. Clinical benefits were assessed by changes in micturition patterns, cystometry and patient preferences. Ninety-one patients were evaluated after 3 months and seventy after both 3 and 6 months. Terodiline was in most patients well tolerated and adverse reactions, usually those to be expected from the pharmacological effects of the drug, caused withdrawals in 12 patients. Mean levels of all variables on clinical chemistry were well within the normal range. No significant changes were seen except for a small increase in B-thrombocytes, S-creatinine and ESR. No significant changes in heart rate or blood pressure occurred except for a small but statistically significant increase (about 2 mmHg) in resting diastolic blood pressure after 6 months. A statistically significant decrease of voluntary as well as involuntary micturitions was seen. The number of voluntary micturitions decreased from a mean of 10.8 during run-in by 2.4 per day (p less than 0.01) during the first period and by 2.5 per day (p less than 0.01) during the whole 6-month therapy. Involuntary micturitions decreased by 1.3 from 2.7 per day (p less than 0.01) after 3 months and by 1.1 per day (p less than 0.01) after 6 months. Both bladder volume at first sensation to void and the maximum cystometric bladder capacity increased significantly from 134 ml by 56 (p less than 0.01) and 63 ml (p less than 0.01) after 3 and 6 months and from 252 ml by 54 (p less than 0.01) and 66 ml (p less than 0.01) after 3 and 6 months, respectively. No significant changes in bladder pressure or residual urine were shown.(ABSTRACT TRUNCATED AT 400 WORDS)
D000293:Adolescent; D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D001799:Blood Sedimentation; D002082:Butylamines / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D002245:Carbon Dioxide / Q000494:pharmacology; D002986:Clinical Trials as Topic; D003404:Creatinine / Q000097:blood; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008875:Middle Aged; D001743:Urinary Bladder / Q000503:physiopathology; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000503:physiopathology; D014554:Urination / Q000187:drug effects
D002082:Butylamines; D002121:Calcium Channel Blockers; D002245:Carbon Dioxide; C010637:terodiline; D003404:Creatinine