BACKGROUND: We conducted a randomized clinical trial to investigate the efficacy of the selective α(1A)-adrenoceptor antagonist tamsulosin in preventing acute voiding difficulty after rectal cancer surgery. METHODS: A total of 94 rectal cancer patients with an International Prostate Symptom Score (IPSS) of ≤7 were randomly assigned (1:1) to the tamsulosin group (0.2 mg/day orally for 7 days) (n = 47) or the control group (n = 47). The primary endpoint was the reinsertion rate of the urinary catheter after its removal on postoperative day (POD) 3. The secondary endpoints included the maximum (Qmax) and average (Qavg) urinary flow rates on POD 3, and the voided volume (VV), residual urine volume (RU), and IPSS on POD 7. Analyses were based on an intention-to-treat population. RESULTS: The reinsertion rate of the urinary catheter in the tamsulosin group was similar to that in the control group (23.4 vs. 21.3 %, respectively; p = 0.804). The postoperative voiding parameters and IPSS were not better in the tamsulosin group than in the control group after adjustments were made for the baseline measurements with analysis of covariance (Qmax, p = 0.537; Qavg, p = 0.399; VV, p = 0.645; RU, p = 0.703; IPSS, p = 0.761). Multivariate analysis revealed that being male was the only independent risk factor for reinsertion of the urinary catheter (odds ratio 0.239; 95 % confidence interval 0.069-0.823; p = 0.023). CONCLUSIONS: This controlled trial showed that tamsulosin at 0.2 mg/day does not prevent acute voiding difficulty after rectal cancer surgery.
RCT Entities:
BACKGROUND: We conducted a randomized clinical trial to investigate the efficacy of the selective α(1A)-adrenoceptor antagonist tamsulosin in preventing acute voiding difficulty after rectal cancer surgery. METHODS: A total of 94 rectal cancerpatients with an International Prostate Symptom Score (IPSS) of ≤7 were randomly assigned (1:1) to the tamsulosin group (0.2 mg/day orally for 7 days) (n = 47) or the control group (n = 47). The primary endpoint was the reinsertion rate of the urinary catheter after its removal on postoperative day (POD) 3. The secondary endpoints included the maximum (Qmax) and average (Qavg) urinary flow rates on POD 3, and the voided volume (VV), residual urine volume (RU), and IPSS on POD 7. Analyses were based on an intention-to-treat population. RESULTS: The reinsertion rate of the urinary catheter in the tamsulosin group was similar to that in the control group (23.4 vs. 21.3 %, respectively; p = 0.804). The postoperative voiding parameters and IPSS were not better in the tamsulosin group than in the control group after adjustments were made for the baseline measurements with analysis of covariance (Qmax, p = 0.537; Qavg, p = 0.399; VV, p = 0.645; RU, p = 0.703; IPSS, p = 0.761). Multivariate analysis revealed that being male was the only independent risk factor for reinsertion of the urinary catheter (odds ratio 0.239; 95 % confidence interval 0.069-0.823; p = 0.023). CONCLUSIONS: This controlled trial showed that tamsulosin at 0.2 mg/day does not prevent acute voiding difficulty after rectal cancer surgery.
Authors: S Faithfull; A Lemanska; P Aslet; N Bhatt; J Coe; L Drudge-Coates; M Feneley; R Glynn-Jones; M Kirby; S Langley; T McNicholas; J Newman; C C Smith; A Sahai; E Trueman; H Payne Journal: Int J Clin Pract Date: 2015-08-20 Impact factor: 2.503