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

October 30, 2015 updated by: Mohamed Ali, Mansoura University
The aim of the study is to compare the safety and efficacy of ESWL and visual cystolitholapaxy in management of calcular acute urine retention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • DK
      • Mansoura, DK, Egypt, 35516
        • Recruiting
        • Urology an Nephrology Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: 1 week
evaluation of stone free rate after the assigned intevention
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events after the assigned intervention
Time Frame: 1 month
evaluation of adverse events after the assigned intervention
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Ahmed A Shokeir, Prof, Urology and Nephrology Cenetr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MALI1112015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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