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. 2018 Sep 14;18(1):80.
doi: 10.1186/s12894-018-0394-8.

Anticholinergic burden and comorbidities in patients attending treatment with trospium chloride for overactive bladder in a real-life setting: results of a prospective non-interventional study

A Ivchenko  1 , R-H Bödeker  2 , C Neumeister  3 , A Wiedemann  1
Affiliations

Anticholinergic burden and comorbidities in patients attending treatment with trospium chloride for overactive bladder in a real-life setting: results of a prospective non-interventional study

A Ivchenko et al. BMC Urol. .

Abstract

Background: Elderly people are representative for the patients most likely to be treated with anticholinergics for overactive bladder (OAB). They often receive further drugs with anticholinergic properties for concomitant conditions. This increases the risk for side effects, including central nervous system disorders. Data on comorbidities and baseline anticholinergic burden of OAB patients seen in urological practice is scarce. Therefore, we included an epidemiological survey on these issues in our study which assessed the effectiveness and tolerability of trospium chloride (TC) in established dosages under routine conditions.

Methods: Outpatients (≥ 65 years of age), for whom treatment with TC was indicated, were eligible to participate in this non-interventional, prospective study performed in 162 urological practices in Germany. Epidemiological questions were evaluated by the Anticholinergic Burden (ACB) scale and the Cumulative Illness Rating Scale for Geriatrics (CIRS-G) at baseline. Efficacy was assessed by changes in symptom-related variables of OAB after treatment. Dosage regimen, duration of treatment, adverse events, withdrawals, and ease of subdivision of the prescribed SNAP-TAB tablet were documented. Patients and physicians rated efficacy and tolerability of treatment. Statistics were descriptive.

Results: Four hundred fourty-five out of 986 (47.54%) patients in the epidemiological population had a baseline ACB scale score > 0, 100 (24.72%) of whom a score ≥ 3. The median CIRS-G comorbidity index score for all patients was 5. 78.55% (608/774) of patients in the efficacy population received a daily dose of 45 mg TC. 60.03% (365/608) of them took this dose by dividing the SNAP-TAB tablet in three equal parts. Before-after-comparisons of the core symptoms of OAB showed clear improvements. An influence of the dosage scheme (1 × 45 mg TC/d vs 3 × 15 mg TC/d) on clinical outcome could not be observed. Most urologists and patients rated TC treatment as effective and well tolerated. 44 (4.37%) out of 1007 patients in the safety collective ended their treatment prematurely, while 75 patients (7.45%) experienced adverse events.

Conclusions: Anticholinergic burden and comorbidities in elderly OAB patients are frequent. The acceptance of the SNAP-TAB tablet, which facilitates flexible dosing with TC, was high, which is supportive in ensuring adherence in therapy.

Trial registration: This non-interventional study was registered on October 29, 2014 with the number DRKS00007109 at the German Register of Clinical Studies (DRKS).

Keywords: Anticholinergic burden; CIRS-G; Comorbidity index; Elderly patients; Non-interventional study; Overactive bladder; Trospium chloride.

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Conflict of interest statement

Ethics approval and consent to participate

All procedures performed in this study were in accordance with the German Drug Law, with the joint recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute relating to the conduct of non-interventional trials [37], and with the recommendations for assuring Good Epidemiological Practice [38]. Written informed consent regarding data protection was obtained from all patients before being included in the study. The Ethics Committee of the Medical Chamber Westphalia-Lippe and the Westphalian Wilhelm University Münster, Germany, approved the study protocol. This decision was provided to each urologist within the regulatory jurisdiction of the Ethics Committee. No further Ethics Committee was involved as ethics approval in general was not mandatory and all participating urologists were satisfied with the vote of the Ethics Committee of the Medical Chamber Westphalia-Lippe and Westphalian Wilhelm University Münster.This NIS was registered with the number DRKS00007109 at the German Register of Clinical Studies (DRKS) on October 29, 2014.

Consent for publication

Not applicable.

Competing interests

Alexander Ivchenko received cost reimbursement of travel expenses by Dr. R. Pfleger GmbH. Rolf-Hasso Bödeker is paid-consultant (statistical planning and analysing) to Dr. R. Pfleger GmbH, Andreas Wiedemann is a consultant of Dr. R. Pfleger GmbH, Claudia Neumeister is employee (Senior Project Manager Clinical Research) of Dr. R. Pfleger GmbH.

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Figures

Fig. 1
Fig. 1
Assignment of patients to the analytical populations
Fig. 2
Fig. 2
Frequency distribution of patients with an ACB scale score > 0 at baseline (n = 445). The percent data refer to 936 patients of the epidemiological population. An ACB scale score of ≥3 was considered clinically relevant [19]
Fig. 3
Fig. 3
Prescribed daily doses of TC (mg/day) at Visit 1 – Efficacy population (n = 774)
Fig. 4
Fig. 4
Changes in dose or dosage regimen at Visit 2 (n = 772/774) – Efficacy population
Fig. 5
Fig. 5
Ease of subdivision analysis (n = 758) – Efficacy population. Frequency distribution of the “ease of subdivision rating at Visit 3 or, as applicable, at the time of premature discontinuation of treatment” by age classes
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