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Completed

NCT Number: NCT04000178

OPTIMAL STENTS DURING RENAL COLIC

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.

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Key information

Conditions

Ureteral Stent Occlusion

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Pavlov Saint Petersburg University

Saint Petersburg, 197342, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria included age (18 to 60 years old),
  • confirmed ureteral stone
  • prescribed ureteral stent placement for pain syndrome relief

Exclusion criteria

  • an active urinary tract infection.

Treatment and study plan

polyurethane stent

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

silicone stent

Device

silicone stent

Primary outcomes

  1. 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

  2. bladder overactivity

    Time frame: 4 weeks

    At each follow-up appointment, patients completed a survey in which the "bladder awareness tool" (VASP) was filled

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2019
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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