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

NCT ID: NCT02594631

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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

Conditions

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Urinary Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESWL Group

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

Group Type ACTIVE_COMPARATOR

ESWL

Intervention Type PROCEDURE

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

Endoscopy group

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

Group Type ACTIVE_COMPARATOR

Endoscopic treatment

Intervention Type PROCEDURE

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

Interventions

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ESWL

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

Intervention Type PROCEDURE

Endoscopic treatment

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

Intervention Type PROCEDURE

Other Intervention Names

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Extracorporeal shock wave lithotripsy Visual litholapaxy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali

Resident in Urology, Urology and Nephrology Center, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed A Shokeir, Prof

Role: STUDY_CHAIR

Urology and Nephrology Cenetr

Locations

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Urology an Nephrology Center

Al Mansurah, DK, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed I Ali, Dr

Role: CONTACT

0020502202222

Facility Contacts

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Mohamed I Ali, Dr

Role: primary

0020502262222

Other Identifiers

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MALI1112015

Identifier Type: -

Identifier Source: org_study_id

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