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

Completed

• Conditions: Kidney Stones

• Registration Number: NCT01637519
• Lead Sponsor: University of British Columbia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-11
• Study Start: 2012-08
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief of hydronephrosis (fluid in kidney causing kidney swelling)	1-2 weeks following stent placement	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.

Secondary Outcome Measures

Name	Time	Method
Pain relief	0, 1, 2, 3, 4, 5, 6, 7 post stent placement, and days 1 and 7 post stent removal	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.
Migration of stent	1-2 weeks following stent placement	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.

Trial Locations

Locations (2)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion; 🇨🇦 Vancouver, British Columbia, Canada