Ureteral Stent OcclusionNCT04000178
OPTIMAL STENTS DURING RENAL COLIC
A study testing polyurethane stent and silicone stent in people with Ureteral Stent Occlusion, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ureteral Stent Occlusion
- What is being tested?
- polyurethane stent and silicone stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2018to 10 Oct 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- confirmed ureteral stone
- prescribed ureteral stent placement for pain syndrome relief
Who cannot join
- an active urinary tract infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY
From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.
- Conditions
- Ureteral Stent Occlusion
- Being tested
- polyurethane stent, silicone stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyurethane stentDevice
patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group
silicone stentDevice
silicone stent
| Study group | Role | What they receive |
|---|---|---|
| group A | Other | patients who received polyurethane stents Receives: Device: polyurethane stent |
| group B | Experimental | patients who received silicone stents Receives: Device: silicone stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
body pain
At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled
Measured: 4 weeks
bladder overactivity
At each follow-up appointment, patients completed a survey in which the "bladder awareness tool" (VASP) was filled
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Jun 2018
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteral Stent OcclusionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nariman.gadjiev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000178
- Sponsor's protocol ID
- 217
- Status last verified
- Oct 2022
- First submitted
- 23 Jun 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gadzhiev N, Gorelov D, Malkhasyan V, Akopyan G, Harchelava R, Mazurenko D, Kosmala C, Okhunov Z, Petrov S. Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study. BMC Urol. 2020 Feb 3;20(1):10. doi: 10.1186/s12894-020-0577-y.
PubMed 32013936
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT04000178
- Acronym / sponsor ID
- 217
- Conditions
- Ureteral Stent Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 27 Jun 2019 (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.
From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Device: polyurethane stentpatients who received polyurethane stents |
| group B | Experimental | Device: silicone stentpatients who received silicone stents |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- confirmed ureteral stone
- prescribed ureteral stent placement for pain syndrome relief
Key exclusion criteria (1 listed)
- an active urinary tract infection.
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 |
|---|---|---|
| polyurethane stentpatients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group | Device | group A |
| silicone stentsilicone stent | Device | group B |
Primary outcome
body pain
Time frame: 4 weeks
At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled
bladder overactivity
Time frame: 4 weeks
At each follow-up appointment, patients completed a survey in which the "bladder awareness tool" (VASP) was filled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 32013936Gadzhiev N, Gorelov D, Malkhasyan V, Akopyan G, Harchelava R, Mazurenko D, Kosmala C, Okhunov Z, Petrov S. Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study. BMC Urol. 2020 Feb 3;20(1):10. doi: 10.1186/s12894-020-0577-y.
- Individual participant dataSharing planned: Undecided
Related trials for Ureteral Stent Occlusion
Recruiting
Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
Ureteral Stenosis, Hydronephrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyurethane stent and silicone stent in people with Ureteral Stent Occlusion, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body pain (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000178, which also lists 1 linked publication.
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 13 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.