Migration of Intraureteral Stents Compared to Conventional Double-J Stents.

April 21, 2022 updated by: Kellen Choi, University of Louisville
The purpose of this study is to determine if stents placed with only one loop in the kidney move more than stents placed with a loop in both the kidney and a bladder. Participants in this study will undergo placement of a stent into the ureter that drains urine from the kidney into the bladder. The stent will be placed in 1 of 2 ways: either with only a loop of the stent is left in the kidney or in the regular manner where a loop of the stent is left in both the kidney and in the bladder. The position of the stent will be measured at the time of placement. When the stent is removed, the position of the stent will be measured prior to pulling the stent.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The ureteral stent is one of the most extensively used tools in the field of urology. They are used for aiding post-operative healing of the ureter, visualizing the ureteral during procedures, and alleviating ureteral obstruction (eg. nephrolithiasis). Double-J stents, which are secured by loops in both the renal pelvis and the bladder, have become most urologists' go-to choice for ureteral stents since they were introduced in the 1970s. Unfortunately, it has been shown that 80-90% of patients with ureteral stents have urinary complaints following stent placement.

Interestingly, a recent study suggested utility of intraureteral stents. These stents have one loop in the renal pelvis while their distal end is positioned proximal to the ureteral orifice. The above-mentioned study showed that patients with intraureteral stents had less discomfort as opposed to the those that had double-J stents.

Due to the immense number of patients that require ureteral stent placement, this improvement in comfort is very promising for the urological field. However, no one has studied if stents placed intraureterally migrate from the time they are placed to the time they are removed. If stents migrate proximally toward the renal pelvis, it is possible that retrieval could be more difficult, and the ureteral patency established by the stent could be compromised.

The objective of this study is to determine if intraureterally placed stents migrate as compared to ureteral stents placed via the conventional method.

This study will be a prospective, randomized controlled, single-blinded trial. The subjects will include up to 140 patients (about 70 subjects per group) from ages 1-100 years old that are to undergo stent placement for nephrolithiasis, hydronephrosis, and urological cancer.

Prior to the procedure, each patient that has agreed to participate in this study will be randomly assigned to receive a stent placed intraureterally or a stent placed in the conventional manner. After each intraureteral stent is placed via cystoscopy, the distance of the distal end of the stent to the ureteral orifice will be measured via fluoroscopy that was calibrated prior to the procedure. After each double-J stent is placed via cystoscopy, the length of stent that is present in the bladder will also be measured using calibrated fluoroscopy . Subjects will not be informed of which group they are assigned to. When the patients return for stent removal, the previously mentioned distances will be measured again prior to pulling the stent. They will also be asked to complete the ureteral stent symptom questionnaire (USSQ) to assess stent-associated discomfort. The primary endpoint of the study would be stent migration distance (mm). Secondary endpoints would include patient comfort level.

All medical records will be accessed on secure devices and networks. All subjects will be assigned a subject number upon enrolled in the study. When a researcher needs to record data from a patient's medical records, they will record this information with the patient's corresponding subject number. Only the researchers involved in this study will have access to the document that includes patient identifiers and their subject number. At the conclusion of this study, the document with patient identifiers and subject numbers will be destroyed.

Data will be collected from electronic medical records of patients from ULP (University of Louisville Physicians) Urology.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 98 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those undergoing ureteral stent placement for nephrolithiasis, hydronephrosis, and urological cancer.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraureteral stent group
Patients assigned to this group will undergo placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in only in the kidney and NOT in the bladder. This group will be the experimental group.
Device: Intraureteral stent
This intervention involves the placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube only in the kidney and NOT in the bladder. The distal end of the tube will stay in the ureter just proximal to the opening to the bladder.
Other Names:
  • Polaris™ Loop Ureteral Stent - Boston Scientific
Active Comparator: Conventional Double-J stent
Patients assigned to this group will undergo placement of a double-J ureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and the bladder. This group will serve as the control.
Device: Conventional Double-J stent
This intervention involves the placement of a conventional double-J stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and in the bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent migration
Time Frame: 12 months
The distance that the stent migrates into the bladder or into the kidney.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient comfort level
Time Frame: 12 months
Patient comfort level, as assessed via the Ureteral stent symptom questionnaire (USSQ).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Kellen B Choi, DO, FACOS, Associate Professor, University of Louisville Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2027

Primary Completion (Anticipated)

April 1, 2028

Study Completion (Anticipated)

April 1, 2028

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.0563

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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