Use of the PercSys MicroStent Device to Alleviate Ureteral Stone Symptoms and Hydronephrosis

Kidney stones cause severe pain. Patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. This tube, or ureteral stent, gives the patient relief until they can have their stone treated. This study is to evaluate a new type of ureteral stent to relieve pain from kidney stones. This stent is designed to drain the kidney and unlike other ureteral stents, is also designed to widen the ureter to help the stone pass on its own.

Study Overview

• Status: Completed
• Conditions: Kidney Stones

Detailed Description

This study is to evaluate a new type of ureteral stent to relieve kidney obstruction from a stone lodged in the ureter. This stent would be placed when a patient presents with pain in the Emergency Room or clinic in a patient that has no signs of infection. It is designed to continue drainage of the kidney and unlike other ureteral stents, is also designed to help dilate the ureter to facilitate spontaneous stone passage. This means the stent may also be therapeutic and the patient would be less likely to undergo another procedure to have the stone removed. Research performed at the Stone Centre at VGH shows that in ex vivo pig kidneys, this stent provides very good urinary drainage of the kidney. This has been published in a peer-reviewed journal (Lange D, Hoag NA, Poh BK, Chew BH. Drainage characteristics of the 3F MicroStent using a novel film occlusion anchoring mechanism. J Endourol. 2011 Jun;25(6):1051-6.).

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada
      • Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that present with a unilateral, mid- or distal, ureteral stone that require stent placement to relieve stone symptoms

Description

Inclusion Criteria:

1. Perforation of the urinary tract;
2. Acute hemorrhage;
3. Tissue trauma;
4. Edema;
5. Submucosal tunneling of guidewire or device during advancement; and

6. Protein encrustation of the device.

   Exclusion Criteria:

7. Infection;
8. Hemorrhage;
9. Complications associated with the use of anesthesia,
10. Perforation of the urethra or bladder,
11. Scarring or stricture of the urethra; and
12. Urinary retention due to urethral edema.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ureteral stone; Ten (10) patients with a unilateral, mid- or distal, ureteral (tube connecting kidney and bladder in the urinary system) stone will be enrolled and brought to completion in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief of hydronephrosis (fluid in kidney causing kidney swelling)	Patients will return for radiographic test(s) after the stent placement as determined by the physician which can include kidney-ureter-bladder (KUB) x-ray, renal and bladder ultrasound, or CT scan. This imaging helps determine 2 things: the degree of kidney swelling (hydronephrosis), stent migration and whether their stone is still present or not.	1-2 weeks following stent placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Before stent placement the subject will complete Visual Analog Scale (VAS) questionnaire. After stent placement and discharge home study questionnaires will be completed each day at the end of the day, until stent removal which will be in approximately 7 days. Each VAS questionnaire takes approximately 10 minutes to complete. The subject will be instructed to bring these at their clinic visit for stent removal at Vancouver General Hospital. After the stent removal 2 more questionnaires are completed, at 1 day and at 7 days. These are sent back in a stamped return envelope.	0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal
Migration of stent	Patients will return for radiographic test(s) after the stent placement as determined by the physician which can include kidney-ureter-bladder (KUB) x-ray, renal and bladder ultrasound, or CT scan. This imaging helps determine 2 things: the degree of kidney swelling (hydronephrosis), stent migration and whether their stone is still present or not.	1-2 weeks following stent placement

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Percutaneous Systems, Inc.
• Investigators: Principal Investigator: Ben H Chew, MD, University of British Columbia, Vancouver General Hospital; Study Director: Ryan F Paterson, MD, University of British Columbia, Vancouver General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (ESTIMATE): July 11, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: stent; kidney stones; ureteral stones
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Hydronephrosis
• Other Study ID Numbers: H11-00383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO