Urinary CalculiNCT01884870
Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy
A study testing Surgical Treatment in people with Urinary Calculi, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Calculi
- What is being tested?
- Surgical Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Aug 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi.
- Patient willing to participate in the study
- Complete pre/post-operative work-up
Who cannot join
- Treatment outside our institution
- No will to be a part of the study
- Incomplete pre/post-operative work-up
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinics Hospital - University of Sao Paulo Medical School
São Paulo, São Paulo, 05403-000
Eduardo Mazzucchi, PhD, 55-11-26618080, mazuchi@terra.com.br
Giovanni S Marchini, MD
About this study
Official title: The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis
Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.
Read the detailed description
The prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in North America and 10.1% in Italy. The widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. Clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. Therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health.
The situation becomes even more distressing when managing asymptomatic stones. Studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. The guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. Conversely, the same is not true for silent ureterolithiasis. The purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.
- Conditions
- Urinary Calculi
- Being tested
- Surgical Treatment
- Keywords
- Asymptomatic, ureteral, calculi, renal function, treatment
- Medical subject headings
- Urinary Calculi, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical TreatmentProcedure or surgery
Also called Surgical Treatment - open, endoscopic or laparoscopic
Surgical Treatment - open, endoscopic or laparoscopic
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment | Other | Silent Ureteral Stone - Surgical Treatment Receives: Procedure: Surgical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Renal Function
Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.
Measured: 1 year
Secondary outcomes (3)
Serum Creatinine level
Serum Creatinine level
Measured: 1 year
Estimated Creatinine Clearance
Estimated Creatinine Clearance
Measured: 1 year
Renal Anatomy assessed by Ultrasound
Renal Anatomy assessed by Ultrasound
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (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 University of Sao PauloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Scala Marchini, University of Sao Paulo
- Investigators
- Giovanni S Marchini, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884870
- Sponsor's protocol ID
- CAAE: 01187012.2.0000.0068
- Other IDs
- Online Number: 9015
- Status last verified
- Jun 2015
- First submitted
- 19 Jun 2013
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Silent Ureteral Stone on Renal Function and Kidney Anatomy: a Prospective Analysis
- ClinicalTrials.gov ID
- NCT01884870
- Acronym / sponsor ID
- CAAE: 01187012.2.0000.0068
- Conditions
- Urinary Calculi
- Keywords
- Asymptomatic, ureteral, calculi, renal function, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 24 Jun 2013 (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.
Ureteral stones may be silent in 5.3% of patients. The goal of this study was to prospectively evaluate the impact of a silent ureteral stone on renal function.
Detailed description
The prevalence of nephrolithiasis is increasing worldwide, reaching 5.2% in North America and 10.1% in Italy. The widespread use of computed tomography and ultrasonography have resulted in a greater detection rate of asymptomatic stones and, in part, might explain the trend. Clinically, kidney or ureteral stones range in severity from asymptomatic to presenting with complete renal failure. Therefore, it is not only the alarming incidence of urinary stone disease, but also the associated burden that makes this one of the most concerning conditions in public health.
The situation becomes even more distressing when managing asymptomatic stones. Studies of the natural history of stones have revealed that only 20% of patients yearly actually become symptomatic from a new stone, and one half of those require surgical intervention at some point. The guidelines are well established for the treatment of symptomatic urolithiasis, and many investigators have extensively studied the management of silent kidney stones. Conversely, the same is not true for silent ureterolithiasis. The purpose of the present study is to report the investigators experience managing silent ureteral stones and to prospectively analyze their true influence on renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment | Other | Procedure: Surgical TreatmentSilent Ureteral Stone - Surgical Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Silent ureteral stone: no subjective/objective symptoms related to the ureteral calculi.
- Patient willing to participate in the study
- Complete pre/post-operative work-up
Key exclusion criteria (3 listed)
- Treatment outside our institution
- No will to be a part of the study
- Incomplete pre/post-operative work-up
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 |
|---|---|---|
| Surgical TreatmentAlso: Surgical Treatment - open, endoscopic or laparoscopicSurgical Treatment - open, endoscopic or laparoscopic | Procedure or surgery | Surgical Treatment |
Primary outcome
Ipsilateral Renal Function
Time frame: 1 year
Ipsilateral renal function determined by dimercaptosuccinic acid scintigraphy (DMSA) 12 months after surgery.
3 secondary outcomes
Serum Creatinine level
Time frame: 1 year
Estimated Creatinine Clearance
Time frame: 1 year
Renal Anatomy assessed by Ultrasound
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
Related trials for Urinary Calculi
Not yet recruitingPhase 4
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
Calculus of Upper Urinary Tract
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
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.
Giovanni S Marchini, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Treatment in people with Urinary Calculi, run by University of Sao Paulo at 1 site in Brazil.
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 4 Jun 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 Brazil. 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.
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 Giovanni S Marchini, MD (55-11-98179-8186, giovanni_marchini@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Renal Function (time frame: 1 year). 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 4 Jun 2015.