Comparison of the efficacy and safety of tolterodine 2 mg and 4 mg combined with an α‐blocker in men with lower urinary tract symptoms (LUTS) and overactive bladder: a randomized controlled trial. (23rd September 2015)

• Record Type: Journal Article
• Authors: Kim, Tae Heon; Jung, Wonho; Suh, Yoon Seok; Yook, Soonhyun; Sung, Hyun Hwan; Lee, Kyu‐Sung
• Is Part Of: BJU international. Volume 117:Number 2(2016:Jan.)
• Page Start: 307
• Page End: 315
• Publication Date: 2015-09-23
• Subjects: benign prostatic hyperplasia -- overactive bladder -- anticholinergics; Genitourinary organs -- Diseases -- Periodicals; Genitourinary organs -- Surgery -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1111/bju.13267
• Languages: English
• ISSNs: 1464-4096

Abstract

Abstract : Objective: To evaluate the efficacy and safety of low‐dose (2 mg) tolterodine extended release (ER) with an α‐blocker compared with standard‐dose (4 mg) tolterodine ER with an α‐blocker for the treatment of men with residual storage symptoms after α‐blocker monotherapy. Patients and Methods: The study was a 12‐week, single‐blind, randomized, parallel‐group, non‐inferiority trial that included men with residual storage symptoms despite receiving at least 4 weeks of α‐blocker treatment. Inclusion criteria were total International Prostate Symptom Score (IPSS) ≥12, IPSS quality‐of‐life item score ≥3, and ≥8 micturitions and ≥2 urgency episodes per 24 h. The primary outcome was change in the total IPSS score from baseline. Bladder diary variables, patient‐reported outcomes and safety were also assessed. Results: Patients were randomly assigned to addition of either 2 mg tolterodine ER ( n = 47) or 4 mg tolterodine ER ( n = 48) to α‐blocker therapy for 12 weeks. Patients in both treatment groups had a significant improvement in total IPSS score (−5.5 and −6.3, respectively), micturition per 24 h (−1.3 and −1.7, respectively) and nocturia per night (−0.4 and −0.4, respectively). Changes in IPSS, bladder diary variables, and patient‐reported outcomes were not significantly different between the treatment groups. All interventions were well tolerated by patients. Conclusions: These results suggest that 12 weeks of low‐dose tolterodine ER add‐on therapy is similar to standard‐dose tolterodine ER add‐on therapy in terms of efficacy and safety for patients experiencing residual storage symptoms after receiving α‐blocker monotherapy.