Efficacy and safety of an non-steroidal anti-inflammatory drug in the management of acute urinary retention.

Phase 2

Withdrawn

• Conditions: Acute Urinary Retention; Benign Prostatic Enlargement; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12614000202662
• Lead Sponsor: Gennimatas General Hospital of Thessaloniki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the percentage of TWOC (Trial without catheter) between the two groups of patients. Success of TWOC was defined if patients had a PVR (post void residual) < 100ml after voiding at least 100 mL of urine and did not require recatheterization for a period of 24 hours.<br>The PVR is going to be measured by ultrasound scan.[3 days after initial catheterization.]

Secondary Outcome Measures

Name	Time	Method
If there is a statistical significant difference in PVR (Post Void Residual) volume in the first voiding after Foley catheter removal between the two groups of patients.<br>The PVR is going to be measured by ultrasound scan[3 days after initial catheterization.];If there is a statistical significant difference in max flow rate (Qmax) in the first voiding after Foley catheter removal between the two groups of patients. Patients will have an uroflow test.[3 days after initial catheterization.];To record the side effects of each treatment. Possible side effects of treatment include headache, gastric pain, nausea, vomiting, hypertension etc. These side effects are going to be assessed by methods of interviewing the patient.[3 days after initial catheterization.]