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

Mansoura University

Status and phase: Unknown; Phase 4

Conditions: Urinary Calculi

Treatments: Procedure: ESWL; Procedure: Endoscopic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02594631

MALI1112015

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ESWL Group

Active Comparator group

Description:

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

Treatment:

Procedure: ESWL

Endoscopy group

Active Comparator group

Description:

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

Treatment:

Procedure: Endoscopic treatment