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.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Perforation of the urinary tract;
Acute hemorrhage;
Tissue trauma;
Edema;
Submucosal tunneling of guidewire or device during advancement; and
Protein encrustation of the device.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Relief of hydronephrosis (fluid in kidney causing kidney swelling)

Time frame: 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 outcomes

Pain relief

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

Percutaneous Systems, Inc.

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jul 11, 2012
Registry last updated: May 9, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed