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

NCT02594631 | Unknown Phase 4 DMC

• 1 other identifier: MALI1112015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Calculi

Keywords

Urethral stones; Acute Cacular urinary retention; Extracorporeal Shock Wave Lithotripsy (ESWL); Visual lithotripsy; bladder stone

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  evaluation of stone free rate after the assigned intevention

  1 week

Secondary Outcomes (1)

• Adverse events after the assigned intervention

  1 month

Study Arms (2)

ESWL Group

ACTIVE COMPARATOR

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

Procedure: ESWL

Endoscopy group

ACTIVE COMPARATOR

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

Procedure: Endoscopic treatment

Interventions

ESWL PROCEDURE

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

Also known as: Extracorporeal shock wave lithotripsy

ESWL Group

Endoscopic treatment PROCEDURE

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

Also known as: Visual litholapaxy

Endoscopy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Bladder cancer.
• Bladder replacement of any type.
• Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology an Nephrology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Calculi; Urinary Bladder Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed A Shokeir, Prof

  Urology and Nephrology Cenetr

  STUDY CHAIR

Central Study Contacts

Mohamed I Ali, Dr

CONTACT

0020502202222; dr.m.ali.board@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Urology, Urology and Nephrology Center, Mansoura University

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

EG (1)