nitinol and Prostatic-Neoplasms

To report the 3-year results of a prospective, single arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO).. Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5-7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien-Dindo-Grading System), functional results (Qmax, IPSS, PVR) and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. Sexual and ejaculatory function were evaluated using two yes/no questions.. Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by -58.2, -55.6, +114.7, and -85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements of the functional outcomes if compared with baselines values (all p < 0.0001). No late post-operative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months.. Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late post-operative complications, ejaculatory dysfunction or additional treatment failures were observed between 24 and 36 months.

Topics: Aged; Aged, 80 and over; Alloys; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Prognosis; Prospective Studies; Prostatic Hyperplasia; Prostatic Neoplasms; Prostheses and Implants; Quality of Life

In magnetic resonance imaging, implantable devices are usually visualized with a negative contrast. Recently, positive contrast techniques have been proposed, such as susceptibility gradient mapping (SGM). However, SGM reduces the spatial resolution making positive visualization of small structures difficult. Here, a development of SGM using the original resolution (SUMO) is presented. For this, a filter is applied in k-space and the signal amplitude is analyzed in the image domain to determine quantitatively the susceptibility gradient for each pixel. It is shown in simulations and experiments that SUMO results in a better visualization of small structures in comparison to SGM. SUMO is applied to patient datasets for visualization of stent and prostate brachytherapy seeds. In addition, SUMO also provides quantitative information about the number of prostate brachytherapy seeds. The method might be extended to application for visualization of other interventional devices, and, like SGM, it might also be used to visualize magnetically labelled cells.

Topics: Alloys; Aortic Aneurysm, Thoracic; Aortic Dissection; Brachytherapy; Computer Simulation; Gadolinium; Humans; Imaging, Three-Dimensional; Magnetic Resonance Imaging; Male; Models, Theoretical; Organometallic Compounds; Phantoms, Imaging; Prostatic Neoplasms; Software; Stents

Topics: Alloys; Equipment Safety; Foreign-Body Migration; Hematuria; Humans; Male; Prostatic Hyperplasia; Prostatic Neoplasms; Prosthesis Design; Stents; Urinary Incontinence; Urination

To evaluate the results obtained using a permanent prostatic stent system (Memotherm, Bard/ Angiomed, Karlsruhe, Germany) in high-risk patients with advanced prostatic carcinoma and subvesical obstruction.. The study included 35 patients (mean age 75.3 years, range 53-89) with advanced prostatic carcinoma and persistent subvesical obstruction despite androgen ablation. Because of serious concurrent diseases, 49% of these patients were classified as American Society of Anesthesiologists (ASA) grade 3 and 51% as ASA grade 4. The patients were treated using the Memotherm stent, a thermosensitive Nitinol mesh stent. The outcome was assessed by measuring voiding variables, a symptom score and as the incidence of complications.. After inserting the stent, 33 (94%) of the patients were able to void spontaneously and there was a statistically significant improvement in the voiding variables. These results remained unchanged over a mean (range) follow-up of 15.2 months (3-38). There were no serious complications arising from the insertion of the stent.. For high-risk patients with subvesical obstruction caused by prostatic carcinoma, the insertion of a permanent metal stent system offers a useful alternative treatment to transurethral resection.

Topics: Aged; Aged, 80 and over; Alloys; Humans; Male; Middle Aged; Prostatic Neoplasms; Stents; Urethral Obstruction