Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Mansoura University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Stone free rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Stone free rate
Time Frame: 1 week
evaluation of stone free rate after the assigned intevention
Secondary Outcomes
- Adverse events after the assigned intervention(1 month)
Investigators
Mohamed Ali
Resident in Urology, Urology and Nephrology Center, Mansoura University
Mansoura University