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

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02594631

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Calculi	Procedure: ESWL Procedure: Endoscopic treatment	Phase 4

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ESWL Group Patients in this arm will receive ESWL as treatment for acute calcular urinary retention	Procedure: ESWL Patients in this arm will receive ESWL for treatment of acute calcular urinary retention Other Names: Extracorporeal shock wave lithotripsy
Active Comparator: Endoscopy group Patients in this arm will receive endoscopic treatment for acute calcular urinary retention	Procedure: Endoscopic treatment Patients in this arm will receive endoscopic treatment of acute calcular urinary retention Other Names: Visual litholapaxy

Arm

Intervention/Treatment

Active Comparator: ESWL Group

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

Procedure: ESWL

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

Other Names:

Extracorporeal shock wave lithotripsy

Active Comparator: Endoscopy group

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

Procedure: Endoscopic treatment

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

Other Names:

Visual litholapaxy

Outcome Measures

Primary Outcome Measures

Stone free rate [1 week]
evaluation of stone free rate after the assigned intevention

Secondary Outcome Measures

Adverse events after the assigned intervention [1 month]
evaluation of adverse events after the assigned intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.