UrolithiasisNCT04570787
Bladder Catheterization After Mini-PCNL
A study testing Urinary bladder catheterisation in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
60 patients Inclusion Criteria: age from 18 to 70 years Indications for mini-PCNL ASA score: 1-3 Single percutaneous access to pyelocaliceal system Size of solitary calculus up to 2.5 cm Exclusion Criteria: Active urinary tract infection Coagulopathy Clinically significant infravesical obstruction (Qmax less than 10… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Urinary bladder catheterisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2020to 1 Apr 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years
- Indications for mini-PCNL
- ASA score: 1-3
- Single percutaneous access to pyelocaliceal system
- Size of solitary stone up to 2.5 cm
Who cannot join
- Active urinary tract infection
- Coagulopathy
- Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
First Pavlov Saint Petersburg University
Saint Petersburg, 197342
Dmitriy Gorelov, MD, +79217964892, dsgorelov@mail.ru
About this study
Official title: Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)
60 patients
Inclusion Criteria:
- age from 18 to 70 years
- Indications for mini-PCNL
- ASA score: 1-3
- Single percutaneous access to pyelocaliceal system
- Size of solitary calculus up to 2.5 cm
Exclusion Criteria:
- Active urinary tract infection
- Coagulopathy
- Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
Read the detailed description
60 patients after PCNL will be recruited and randomized into 2 groups (30 vs 30):
- No Catheterization after mini-PCNL (study) - the bladder catheterization is not performed.
- Catheterization after mini-PCNL (control) - the bladder will be drained with the urethral catheter.
All patients will fill out the VASP in 2, 6, 12, 24 hours after mini-PCNL. Ultrasound examination of urinary bladder will be performed after mini-PCNL. All the AE will be registered.
- Conditions
- Urolithiasis
- Being tested
- Urinary bladder catheterisation
- Keywords
- Urolithiasis, PCNL, Bladder catheterisation
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary bladder catheterisationProcedure or surgery
Installation of Foley catheter into the urinary bladder
| Study group | Role | What they receive |
|---|---|---|
| No Catheterization | Active comparator | After mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. Bladder catheterization is not performed. Receives: Procedure: Urinary bladder catheterisation |
| Catheterization | Active comparator | After mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. The bladder is to be drained with the urethral catheter in all cases. Receives: Procedure: Urinary bladder catheterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the level of pain in patients
Filling out the VASP score after PCNL by all patients in 2, 6, 12 and 24 hours
Measured: 1 day
Secondary outcomes (1)
To register the AE regarding catheterization or absence of catheterization
Performing ultrasound examination of urinary bladder after PCNL,
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Jul 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570787
- Sponsor's protocol ID
- 04/20-н
- Status last verified
- Nov 2021
- First submitted
- 5 Aug 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)
- ClinicalTrials.gov ID
- NCT04570787
- Acronym / sponsor ID
- 04/20-н
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, PCNL, Bladder catheterisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 30 Sep 2020 (actual)
- 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.
60 patients
Inclusion Criteria:
- age from 18 to 70 years
- Indications for mini-PCNL
- ASA score: 1-3
- Single percutaneous access to pyelocaliceal system
- Size of solitary calculus up to 2.5 cm
Exclusion Criteria:
- Active urinary tract infection
- Coagulopathy
- Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
Detailed description
60 patients after PCNL will be recruited and randomized into 2 groups (30 vs 30):
- No Catheterization after mini-PCNL (study) - the bladder catheterization is not performed.
- Catheterization after mini-PCNL (control) - the bladder will be drained with the urethral catheter.
All patients will fill out the VASP in 2, 6, 12, 24 hours after mini-PCNL. Ultrasound examination of urinary bladder will be performed after mini-PCNL. All the AE will be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Catheterization | Active comparator | Procedure: Urinary bladder catheterisationAfter mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. Bladder catheterization is not performed. |
| Catheterization | Active comparator | Procedure: Urinary bladder catheterisationAfter mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. The bladder is to be drained with the urethral catheter in all cases. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 70 years
- Indications for mini-PCNL
- ASA score: 1-3
- Single percutaneous access to pyelocaliceal system
- Size of solitary stone up to 2.5 cm
Key exclusion criteria (3 listed)
- Active urinary tract infection
- Coagulopathy
- Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
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 |
|---|---|---|
| Urinary bladder catheterisationInstallation of Foley catheter into the urinary bladder | Procedure or surgery | Catheterization, No Catheterization |
Primary outcome
To measure the level of pain in patients
Time frame: 1 day
Filling out the VASP score after PCNL by all patients in 2, 6, 12 and 24 hours
1 secondary outcome
To register the AE regarding catheterization or absence of catheterization
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary bladder catheterisation in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 5 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 9 Nov 2021. 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 Russia. 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 Dmitry S Gorelov (+79217964892, dsgorelov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the level of pain in patients (time frame: 1 day). 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 9 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.