Back to resultsShock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
Primary Purpose
Urinary Calculi
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
ESWL
Endoscopic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Calculi focused on measuring Urethral stones, Acute Cacular urinary retention, Extracorporeal Shock Wave Lithotripsy (ESWL), Visual lithotripsy, bladder stone
Eligibility Criteria
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.
Sites / Locations
- Urology an Nephrology CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ESWL Group
Endoscopy group
Arm Description
Patients in this arm will receive ESWL as treatment for acute calcular urinary retention
Patients in this arm will receive endoscopic treatment for acute calcular urinary retention
Outcomes
Primary Outcome Measures
Stone free rate
evaluation of stone free rate after the assigned intevention
Secondary Outcome Measures
Adverse events after the assigned intervention
evaluation of adverse events after the assigned intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02594631
Brief Title
Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
Official Title
Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi
Keywords
Urethral stones, Acute Cacular urinary retention, Extracorporeal Shock Wave Lithotripsy (ESWL), Visual lithotripsy, bladder stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESWL Group
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive ESWL as treatment for acute calcular urinary retention
Arm Title
Endoscopy group
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive endoscopic treatment for acute calcular urinary retention
Intervention Type
Procedure
Intervention Name(s)
ESWL
Other Intervention Name(s)
Extracorporeal shock wave lithotripsy
Intervention Description
Patients in this arm will receive ESWL for treatment of acute calcular urinary retention
Intervention Type
Procedure
Intervention Name(s)
Endoscopic treatment
Other Intervention Name(s)
Visual litholapaxy
Intervention Description
Patients in this arm will receive endoscopic treatment of acute calcular urinary retention
Primary Outcome Measure Information:
Title
Stone free rate
Description
evaluation of stone free rate after the assigned intevention
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Adverse events after the assigned intervention
Description
evaluation of adverse events after the assigned intervention
Time Frame
1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed I Ali, Dr
Phone
0020502202222
Email
dr.m.ali.board@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Shokeir, Prof
Organizational Affiliation
Urology and Nephrology Cenetr
Official's Role
Study Chair
Facility Information:
Facility Name
Urology an Nephrology Center
City
Mansoura
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed I Ali, Dr
Phone
0020502262222
Email
dr.m.ali.board@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
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