Efficacy and safety of an non-steroidal anti-inflammatory drug in the management of acute urinary retention.
Celecoxib 200 mg once daily in the management of acute urinary retention related to benign prostatic enlargement (BPE). Results of a prospective randomized double-blind placebo-controlled study.
Gennimatas General Hospital of Thessaloniki
70 participants
Apr 1, 2014
Interventional
Conditions
Summary
Benign prostatic hyperplasia (BPH) is the most frequent benign neoplasm in men. It is estimated that many of patients suffering from this disease will experience acute urinary retention (AUR). The immediate management of AUR requires bladder decompression by catheterization. Up to now, alpha1-Blockers are used routinely before catheter removal and considered an appropriate treatment option according to European Urology Association guidelines. This study is the first double-blind prospective study assessing the impact of Celecoxib (200mg), an NSAID (non-steroidal anti-inflammatory drug) added to the standard treatment (a-blocker) on the outcome of a trial without catheter (TWOC) after a first episode of AUR related to BPH.
Eligibility
Inclusion Criteria3
- Patients able to give written informed consent
- First episode of AUR (acute urinary retention)
- Retention urine volume >400 mL
Exclusion Criteria18
- Patients required a suprapubic catheterization
- Clot retention from hematuria
- Positive urine culture
- Postoperative retention after major abdominal or pelvic surgery
- Large residual volume of more than 1 liter
- Confirmed or suspected urethral stricture
- History of prostatic or bladder neck surgery
- Confirmed case of carcinoma prostate
- History of severe orthostatic hypotension
- Patients taking any alpha blocker or any NSAID
- Active peptic ulceration or active gastro-intestinal (GI) bleeding
- Severe hepatic dysfunction
- Estimated renal creatinine clearance <60 ml/min
- Inflammatory bowel disease
- Congestive heart failure (NYHA II-IV)
- Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
- Allergy in NSAIDs or a-blocker
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Interventions
Patients with acute urinary retention will be randomized into 2 groups. Patients in group A will recieve 1 tablet of Alfuzocin 10 mg once daily plus 1 capsule of celecoxib 200 mg once daily, for 3 days and then will have a Trial WithOut Catheter (TWOC). The monitor adherence to treatment is going to be monitored by methods of drug tablet return. The TWOC includes the removal of the Foley catheter and monitoring of first urination after 3 days of initial catheterization.
Locations(1)
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ACTRN12614000202662