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

Urinary Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02594631
• Other study ID #: MALI1112015
• Status: Recruiting
• Phase: Phase 4
• First received: October 30, 2015
• Last updated: October 30, 2015
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: Mansoura University
• Contact: Mohamed I Ali, Dr
• Phone: 0020502202222
• Email: dr.m.ali.board[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Retention

Intervention

Procedure:
• ESWL
Patients in this arm will receive ESWL for treatment of acute calcular urinary retention
• Endoscopic treatment
Patients in this arm will receive endoscopic treatment of acute calcular urinary retention

Locations

Country	Name	City	State
Egypt	Urology an Nephrology Center	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	evaluation of stone free rate after the assigned intevention	1 week	Yes
Secondary	Adverse events after the assigned intervention	evaluation of adverse events after the assigned intervention	1 month	Yes