Urinary CalculiPhase 4NCT02594631
Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
A Phase 4 study testing ESWL and Endoscopic treatment in people with Urinary Calculi, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Urinary Calculi
- What is being tested?
- ESWL and Endoscopic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Bladder cancer.
- Bladder replacement of any type.
- Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology an Nephrology Center
Al Mansurah, DK, 35516
Mohamed I Ali, Dr, 0020502262222, dr.m.ali.board@gmail.com
About this study
The aim of the study is to compare the safety and efficacy of ESWL and visual cystolitholapaxy in management of calcular acute urine retention.
Read the 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
- Conditions
- Urinary Calculi
- Being tested
- ESWL, Endoscopic treatment
- Keywords
- Urethral stones, Acute Cacular urinary retention, Extracorporeal Shock Wave Lithotripsy (ESWL), Visual lithotripsy, bladder stone
- Medical subject headings
- Urinary Calculi, Urinary Bladder Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWLProcedure or surgery
Also called Extracorporeal shock wave lithotripsy
Patients in this arm will receive ESWL for treatment of acute calcular urinary retention
Endoscopic treatmentProcedure or surgery
Also called Visual litholapaxy
Patients in this arm will receive endoscopic treatment of acute calcular urinary retention
| Study group | Role | What they receive |
|---|---|---|
| ESWL Group | Active comparator | Patients in this arm will receive ESWL as treatment for acute calcular urinary retention Receives: Procedure: ESWL |
| Endoscopy group | Active comparator | Patients in this arm will receive endoscopic treatment for acute calcular urinary retention Receives: Procedure: Endoscopic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
evaluation of stone free rate after the assigned intevention
Measured: 1 week
Secondary outcomes (1)
Adverse events after the assigned intervention
evaluation of adverse events after the assigned intervention
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CalculiStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali, Mansoura University
- Investigators
- Ahmed A Shokeir, Prof, Study chair, Urology and Nephrology Cenetr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594631
- Sponsor's protocol ID
- MALI1112015
- Status last verified
- Oct 2015
- First submitted
- 30 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02594631
- Acronym / sponsor ID
- MALI1112015
- Conditions
- Urinary Calculi
- Keywords
- Urethral stones, Acute Cacular urinary retention, Extracorporeal Shock Wave Lithotripsy (ESWL), Visual lithotripsy, bladder stone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL Group | Active comparator | Procedure: ESWLPatients in this arm will receive ESWL as treatment for acute calcular urinary retention |
| Endoscopy group | Active comparator | Procedure: Endoscopic treatmentPatients in this arm will receive endoscopic treatment for acute calcular urinary retention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Bladder cancer.
- Bladder replacement of any type.
- Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer, stricture urethra or external urethral meatal stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWLAlso: Extracorporeal shock wave lithotripsyPatients in this arm will receive ESWL for treatment of acute calcular urinary retention | Procedure or surgery | ESWL Group |
| Endoscopic treatmentAlso: Visual litholapaxyPatients in this arm will receive endoscopic treatment of acute calcular urinary retention | Procedure or surgery | Endoscopy group |
Primary outcome
Stone free rate
Time frame: 1 week
evaluation of stone free rate after the assigned intevention
1 secondary outcome
Adverse events after the assigned intervention
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Shokeir, Prof study chair
Urology and Nephrology Cenetr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESWL and Endoscopic treatment in people with Urinary Calculi, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed I Ali, Dr (0020502202222, dr.m.ali.board@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.