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

Phase 4

• Conditions: Urinary Calculi
• Interventions: Procedure: Endoscopic treatment; Procedure: ESWL

• Registration Number: NCT02594631
• Lead Sponsor: Mansoura University

Brief Summary

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

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

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Primary Completion: 2016-03
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Adult male patients presenting with acute urinary retention due to urethral or urinary bladder stones.
2. with a stone size not more than 2 centimeters in greatest diameter.
3. No more than 2 stones.

Exclusion Criteria

1. Bladder cancer.
2. Bladder replacement of any type.
3. Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopy group	Endoscopic treatment	Patients in this arm will receive endoscopic treatment for acute calcular urinary retention
ESWL Group	ESWL	Patients in this arm will receive ESWL as treatment for acute calcular urinary retention

Primary Outcome Measures

Name	Time	Method
Stone free rate	1 week	evaluation of stone free rate after the assigned intevention

Secondary Outcome Measures

Name	Time	Method
Adverse events after the assigned intervention	1 month	evaluation of adverse events after the assigned intervention

Trial Locations

Locations (1)

Urology an Nephrology Center; 🇪🇬 Mansoura, DK, Egypt