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.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000202662

Enrollment

Registered

2014-02-25

Start date

2014-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients able to give written informed consent 2. First episode of AUR (acute urinary retention) 3. Retention urine volume >400 mL

Exclusion criteria

1. Patients required a suprapubic catheterization 2. Clot retention from hematuria 3. Positive urine culture 4. Postoperative retention after major abdominal or pelvic surgery 5. Large residual volume of more than 1 liter 6. Confirmed or suspected urethral stricture 7. History of prostatic or bladder neck surgery 8. Confirmed case of carcinoma prostate 9. History of severe orthostatic hypotension 10. Patients taking any alpha blocker or any NSAID 11. Active peptic ulceration or active gastro-intestinal (GI) bleeding 12. Severe hepatic dysfunction 13. Estimated renal creatinine clearance <60 ml/min 14. Inflammatory bowel disease 15. Congestive heart failure (NYHA II-IV) 16. Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled. 17. Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease 18. Allergy in NSAIDs or a-blocker

Outcome results