Intermittent Catheterization Versus Trial Without Catheter

Study Overview
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Brief Summary
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This is a prospective, comparative, multicenter, randomized controlled trial. The aim of this study is to compare the efficacy, safety and quality of life within patients with acute urinary retention managed by the intermittent catheterization compared or indwelling Foley catheter.

Official Title
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Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Management of Acute Urinary Retention: Multicenter, Randomized, Controlled Clinical Trial.

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: intermittent catheterization
* Procedure: trial without catheter
* Drug: alpha-blockers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with acute urinary retention due to prostatic hyperplasia Exclusion Criteria: Patient's with serious conditions and incapacity Previous urethral or prostate surgery. Urethral stricture. Urethrorrhagia. Injuries of urethra and perineum. Attempts of bladder catheterization within 15 days before the acute urinary retention episode. Urinary tract infection. Neurogenic bladder. Chronic urinary retention with a bladder volume of more than 1 liter. Obstructive uropathy due to the acute urinary retention.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intermittent catheterization (group B)<br>Procedure/Surgery: The acute urinary retention in group B is managed by clean intermittent catheterization along with alpha-blockers during 3 period. After 3 days the ability of spontaneous voiding is assessed and registered as an outcome. | Procedure: intermittent catheterization<br>* clean intermittent catheterization with catheter Nelaton<br>Drug: alpha-blockers<br>* tamsulosin, alfuzosin, doxazosin, silodosin<br>|
| Active Comparator: Catheter Foley (group A)<br>The acute urinary retention in group A is managed by trial without catheter along with alpha-blockers during 3 period. After 3 days the indwelling Foley catheter is removed and ability of spontaneous voiding is assessed and registered as an outcome. | Procedure: trial without catheter<br>* catheter Foley<br>Drug: alpha-blockers<br>* tamsulosin, alfuzosin, doxazosin, silodosin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the quality of life | Assessment of the quality of life according to the SF-36 questionnaire on the first, second, or third day after the start of intermittent catheterization | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the restoration of self-urination. | A positive outcome is considered to be the restoration of independent urination, and the presence of no more than 150 ml of residual urine in a control study 12-24 hours after the restoration of urination. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, acute urinary retention, intermittent catheterization, urethral catheter, trial without catheter