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SILICONE VERSUS POLYURETHANE URETERAL STENTS DURING ACUTE RENAL COLIC

Sponsor
St. Petersburg State Pavlov Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04000178
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
4.3
Actual Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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). 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.

Condition or Disease Intervention/Treatment Phase
  • Device: polyurethane stent
  • Device: silicone stent
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Oct 10, 2018
Actual Study Completion Date :
Oct 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: group A

patients who received polyurethane stents

Device: 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
Experimental: group B

patients who received silicone stents

Device: silicone stent
silicone stent

Outcome Measures

Primary Outcome Measures

  1. body pain [4 weeks]

    At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled

  2. bladder overactivity [4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Pavlov Saint Petersburg University Saint Petersburg Russian Federation 197342

Sponsors and Collaborators

  • St. Petersburg State Pavlov Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
nariman.gadjiev, Head of endourology, St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier:
NCT04000178
Other Study ID Numbers:
  • 217
First Posted:
Jun 27, 2019
Last Update Posted:
Jun 27, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 27, 2019