Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.

Study Overview
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Brief Summary
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The aim of the study is to compare the safety and efficacy of ESWL and visual cystolitholapaxy in management of calcular acute urine retention.

Detailed Description
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Patients who present with acute urinary retention due to stone in the urethra or urinary bladder will be randomly assigned to receive treatment either by extracorporeal shock wave lithotripsy or by endoscopic visual cystolitholapaxy where patients and stone characteristics will be recorded and the outcome including the intraoperative and postoperative complications and the stone free rate will be also evaluated

Official Title
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Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.

Conditions
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Urinary Calculi

Intervention / Treatment
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* Procedure: ESWL
* Procedure: Endoscopic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male patients presenting with acute urinary retention due to urethral or urinary bladder stones. with a stone size not more than 2 centimeters in greatest diameter. No more than 2 stones. Exclusion Criteria: Bladder cancer. Bladder replacement of any type. Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: ESWL Group<br>Patients in this arm will receive ESWL as treatment for acute calcular urinary retention | Procedure: ESWL<br>* Patients in this arm will receive ESWL for treatment of acute calcular urinary retention<br>* Other names: Extracorporeal shock wave lithotripsy;|
| Active Comparator: Endoscopy group<br>Patients in this arm will receive endoscopic treatment for acute calcular urinary retention | Procedure: Endoscopic treatment<br>* Patients in this arm will receive endoscopic treatment of acute calcular urinary retention<br>* Other names: Visual litholapaxy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | evaluation of stone free rate after the assigned intevention | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events after the assigned intervention | evaluation of adverse events after the assigned intervention | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urethral stones, Acute Cacular urinary retention, Extracorporeal Shock Wave Lithotripsy (ESWL), Visual lithotripsy, bladder stone