Comparison of Cystoscopic Removal Versus Magnetic Device Removal of Ureteral Stents in Renal Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Feasibility and patient comfort of the retrieval device, using standard validated questionnaire Ureteral Stent Symptom Questionnaire (USSQ)
Study Overview
Brief Summary
This is a pilot, single-centre, feasibility study to assess the feasibility issues and collect preliminary clinical data for the design of future randomized controlled trial to evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral stent in transplant patients.
Detailed Description
To curtail the pain and discomfort during cystoscopic stent removal and in order to improve patient's quality of life, a newly developed ureteral stent with a small magnet at its distal end and a customized magnetic retrieval catheter is recently used in Europe. The product is Black-Star® with a retrieval device by Urotech (Achenmühle, Germany). The magnetic Blackstar stent is a ureteral stent with a small magnet fixed with a string at the distal loop. The placement of stent is similar as routinely done on a guidewire, the only difference is to include the magnetic piece over the guidewire. To remove the stent a customized catheter with a magnetic Tiemann tip is used. The catheter is inserted after urethral application of a standard lubricant and removed with the stent after coming in contact with the stent's magnet.
The stent comes in various sizes and is currently being used in Europe. The studies have concluded fast and easy retrieval of stent without requirement of cystoscopy and decreased patient discomfort.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients at least 18 years of age and capable of giving informed consent
- •Patients scheduled for deceased donor renal transplant surgery
Exclusion Criteria
- •Patients undergoing Live donor renal transplant
Arms & Interventions
Magnetic Stent
Patients who are undergoing renal transplant surgery for the treatment of end stage renal failure and randomized for magnetic stent group will receive magnetic stent and the removal of stent would be done by help of magnetic device.
Intervention: Magnetic stent (Device)
Routine stent
Patients who are undergoing renal transplant surgery for the treatment of end stage renal failure and randomized for routine stent would receive routine stent and the removal of stent would be done by cystoscopy
Outcomes
Primary Outcomes
Feasibility and patient comfort of the retrieval device, using standard validated questionnaire Ureteral Stent Symptom Questionnaire (USSQ)
Time Frame: 3-6 weeks
All patients will be followed up 4 weeks post renal transplant surgery, until ureteral stent removal. Feasibility and comfort of stent retrieval, Ureteral Stent Symptom Questionnaire (USSQ) at 4 weeks before stent removal and 1 week post stent removal.
Secondary Outcomes
- Outcome measure: Cost effectiveness(3-6 weeks)
- Outcome measure: Retrieval time(Baseline (intraoperatively))
- Outcome measure: Infection rate(3-6 weeks)
Investigators
Anil Kapoor
Principal Investigator
St. Joseph's Healthcare Hamilton