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Treating bladder-outflow obstruction with thermo-expandable prostate metal stents
A G Papatsoris1, T El-Husseiny, Y Sawada
1Department of Urology, St Bartholomew's Hospital, Barts and The London NHS Trust, London, EC1A 7BE, UK. agpapatsoris@yahoo.gr
Expert Review of Medical Devices
|July 4, 2009
Summary
A novel thermo-expandable prostatic stent offers a minimally invasive solution for bladder-outflow obstruction in elderly, high-risk patients. While effective, long-term functionality requires monitoring for complications like encrustation and migration.
Area of Science:
- Urology
- Biomedical Engineering
Background:
- Bladder-outflow obstruction is a common condition in aging men, often caused by prostate diseases.
- Surgical interventions are not ideal for elderly patients with high-risk profiles requiring less invasive options.
Purpose of the Study:
- To introduce and evaluate a novel thermo-expandable metal stent for treating bladder-outflow obstruction.
- To assess the device's design, performance, limitations, and clinical outcomes in a patient cohort.
Main Methods:
- Review of the thermo-expandable prostatic stent's design characteristics.
- Clinical experience assessment in 127 patients with 192 stent insertions.
- Performance evaluation compared to alternative treatments and analysis of complication rates.
Main Results:
- Stent functionality rates were 82%, 61%, and 47% at 1, 2, and 3 years, respectively.
- Mean indwelling time was 1 year, with a maximum of 4 years.
- Complications requiring stent removal/exchange occurred in 41% of patients, including encrustation, migration, and pain.
Conclusions:
- The thermo-expandable prostatic stent represents an effective minimally invasive treatment for bladder-outflow obstruction.
- This device is particularly beneficial for high-risk elderly patients unsuitable for traditional surgery.
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