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

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

Sponsors

Lead sponsor: Mansoura University

Source 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

Overall Status Unknown status
Start Date March 2015
Completion Date April 2016
Primary Completion Date March 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Stone free rate 1 week
Secondary Outcome
Measure Time Frame
Adverse events after the assigned intervention 1 month
Enrollment 100
Condition
Intervention

Intervention type: Procedure

Intervention name: ESWL

Description: Patients in this arm will receive ESWL for treatment of acute calcular urinary retention

Arm group label: ESWL Group

Other name: Extracorporeal shock wave lithotripsy

Intervention type: Procedure

Intervention name: Endoscopic treatment

Description: Patients in this arm will receive endoscopic treatment of acute calcular urinary retention

Arm group label: Endoscopy group

Other name: Visual litholapaxy

Eligibility

Criteria:

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.

Gender: Male

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ahmed A Shokeir, Prof Study Chair Urology and Nephrology Cenetr
Overall Contact

Last name: Mohamed I Ali, Dr

Phone: 0020502202222

Email: [email protected]gmail.com

Location
facility status contact
Urology an Nephrology Center Recruiting Mohamed I Ali, Dr 0020502262222 [email protected]
Location Countries

Egypt

Verification Date

October 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mansoura University

Investigator full name: Mohamed Ali

Investigator title: Resident in Urology, Urology and Nephrology Center, Mansoura University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ESWL Group

Arm group type: Active Comparator

Description: Patients in this arm will receive ESWL as treatment for acute calcular urinary retention

Arm group label: Endoscopy group

Arm group type: Active Comparator

Description: Patients in this arm will receive endoscopic treatment for acute calcular urinary retention

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov