Abstract
Purpose: We have conducted a prospective open-label study to examine the safety and efficacy
of the long-term administration of the tricyclic antidepressant amitriptyline in patients
with interstitial cystitis (IC). Methods: Patients were stratified into 2 groups: an NIDDK group including patients fulfilling
the NIDDK criteria for IC and a non-NIDDK group encompassing patients who presented
the characteristic IC symptoms but met at least one of the NIDDK exclusion criteria.
Amitriptyline was taken strictly at bedtime following an established self-titration
protocol without a limitation of the maximum daily dosage. Patients reporting improvement
in a global response assessment questionnaire were defined as treatment responders.
Further efficacy measures included changes of pain and urgency, functional bladder
capacity and frequency. Changes in the O’Leary-Sant IC index and rating of overall
satisfaction with the therapeutic outcome are reported as well. Results: The mean follow-up of the study was 19.0 ± 12.5 months. The response rate was 64 %
(60 patients). Overall mean dosage was 55 mg (range: 12.5–150 mg). Side effects occurred
in 79 patients (84 %) (dry mouth: 79 %, weight gain: 59 %). Patient overall satisfaction
with the therapeutic result was either excellent or good in 43 patients (46 %). The
drop-out rate was 31 % (29 patients) after a mean treatment period of 6 weeks at a
mean dosage of 70 mg. Non-response to treatment was the primary reason for drop-out
in all cases, side effects contributed to drop-out in 25 patients (86 %). The various
IC symptoms improved statistically significant compared with baseline. Conclusions: Long-term administration of amitriptyline is a feasible, safe and effective treatment
for IC provided that the drug is used judiciously to minimise adverse effects. The
therapeutic response to amitriptyline was uniformly observed in patients fulfilling
the NIDDK criteria and in those patients with the pure clinical diagnosis of IC.
Key words
amitryptiline - interstitial cystitis - bladder
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Prof. Dr. med. L. Hertle
Universitätsklinikum Münster · Klinik und Poliklinik für Urologie
Albert-Schweitzer-Straße 33
48149 Münster
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Email: urologie@uni-muenster.de