OPTIMAL STENTS DURING RENAL COLIC

NCT ID: NCT04000178

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Ureteral Stent Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

patients who received polyurethane stents

Group Type OTHER

polyurethane stent

Intervention Type DEVICE

patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group

group B

patients who received silicone stents

Group Type EXPERIMENTAL

silicone stent

Intervention Type DEVICE

silicone stent

Interventions

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polyurethane stent

patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group

Intervention Type DEVICE

silicone stent

silicone stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* confirmed ureteral stone
* prescribed ureteral stent placement for pain syndrome relief

Exclusion Criteria

* an active urinary tract infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role lead

Responsible Party

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nariman.gadjiev

Head of endourology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Pavlov Saint Petersburg University

Saint Petersburg, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 32013936 (View on PubMed)

Other Identifiers

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217

Identifier Type: -

Identifier Source: org_study_id

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