Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000202662
Ethics application status
Approved
Date submitted
12/02/2014
Date registered
25/02/2014
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of an non-steroidal anti-inflammatory drug in the management of acute urinary retention.
Scientific title
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.
Secondary ID [1] 284058 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Urinary Retention 291113 0
Benign Prostatic Enlargement 291227 0
Condition category
Condition code
Renal and Urogenital 291455 291455 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288748 0
Treatment: Drugs
Comparator / control treatment
Patients in group B will recieve 1 tablet of Alfuzocin 10 mg once daily plus 1 capsule of placebo (looking similar to the celecoxib capsule in color, weight, and shape) once daily (for 3 days and then will have a TWOC).
Control group
Placebo

Outcomes
Primary outcome [1] 291437 0
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.
The PVR is going to be measured by ultrasound scan.
Timepoint [1] 291437 0
3 days after initial catheterization.
Secondary outcome [1] 306770 0
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.
The PVR is going to be measured by ultrasound scan
Timepoint [1] 306770 0
3 days after initial catheterization.
Secondary outcome [2] 306771 0
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.
Timepoint [2] 306771 0
3 days after initial catheterization.
Secondary outcome [3] 306772 0
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.
Timepoint [3] 306772 0
3 days after initial catheterization.

Eligibility
Key inclusion criteria
1. Patients able to give written informed consent
2. First episode of AUR (acute urinary retention)
3. Retention urine volume >400 mL
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment is going to be centrally accomplished (telephone randomization).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics and the percentages of successful TWOC will be compared between the groups using chi-square test. The assessed PVR and Qmax after first voiding will be compared using Student’s T test.
In order to find a statistically significant difference between two groups, a power analysis was performed. With a power of 90%, 70 patients are needed with an effect size of 0.5.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5813 0
Greece
State/province [1] 5813 0

Funding & Sponsors
Funding source category [1] 288682 0
Self funded/Unfunded
Name [1] 288682 0
Country [1] 288682 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 287392 0
None
Name [1] 287392 0
Address [1] 287392 0
Country [1] 287392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290546 0
Ethics committee of "G. Gennimatas" General Hospital of Thessaloniki
Ethics committee address [1] 290546 0
41 Ethnikis Aminis str, Thessaloniki, 54346.
Ethics committee country [1] 290546 0
Greece
Date submitted for ethics approval [1] 290546 0
Approval date [1] 290546 0
12/07/2013
Ethics approval number [1] 290546 0
9893/ 12.07.2013

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46110 0
Dr Vakalopoulos Ioannis
Address 46110 0
1st Urologic Department of Aristotle University of Thessaloniki, G. Gennimatas General Hospital, 41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 46110 0
Greece
Phone 46110 0
+30 2310963370
Fax 46110 0
Email 46110 0
[email protected]
Contact person for public queries
Name 46111 0
Vakalopoulos Ioannis
Address 46111 0
1st Urologic Department of Aristotle University of Thessaloniki, G. Gennimatas General Hospital, 41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 46111 0
Greece
Phone 46111 0
+30 2310963370
Fax 46111 0
Email 46111 0
[email protected]
Contact person for scientific queries
Name 46112 0
Vakalopoulos Ioannis
Address 46112 0
1st Urologic Department of Aristotle University of Thessaloniki, G. Gennimatas General Hospital, 41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 46112 0
Greece
Phone 46112 0
+30 2310963370
Fax 46112 0
Email 46112 0
[email protected]

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