Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06-study.

PURPOSE: To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Men with symptomatic BPH (IPSS ≥ 10, Qmax < 12 ml/s, and prostate volume (PV) < 120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5-7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien Dindo-Grading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function were assessed according to ISI, MSHQ-EjD and SHIM questionnaires. Post-operative IPSS, QoL, Qmax and PVR were also assessed at 1, 3, and 6 months post-operatively. RESULTS: This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15-80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average post-operative VAS score was 3.24 ± 2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM and MSHQ-EjD questionnaires and significant improvements (p < 0.0001) from baseline levels were recorded in IPSS, QoL and peak flow. CONCLUSION: iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.

The Lifetime History of the First Italian Public Extra-Corporeal Shock Wave Lithotripsy (ESWL) Lithotripter as a Mirror of the Evolution of Endourology over the Last Decade.

Extracorporeal shockwave lithotripsy (ESWL) is the only non-invasive treatment for kidney stones. It does not require an operating room, anesthesia, or hospital stay. Its role evolved over the years and nowadays ESWL is slowly disappearing from many stone centers and urologic departments. We present the history and the role of ESWL treatment since its birth in 1959 and its development through the following years. We also present details of its application and impact on the first Italian stone center in 1985. ESWL has had different roles over the centuries: in the early years it was a great alternative to open surgery and percutaneous nephrolithotripsy (PCNL), then it had its decline with the introduction of the miniscopes. Currently, although ESWL is not considered a treatment of excellence, newer models are emerging. With the application of new technologies and artificial intelligence, this technique can become a good option alongside endourologic treatments.

The Tomato Model.

OBJECTIVES: Percutaneous renal access (PCA) is one of the most difficult intervention in endourology. Hands-on training is a useful tool for a good understanding of the puncturing technique, reducing the learning curve, and lowering risks of complications during first procedures. The ideal surgical simulator should efficiently improve trainees' skills, be easily accessible, low-cost, and realistic. We aim to present novel fluoroscopy-guided PCA simulator named TOMATO model. MATERIALS AND METHODS: The model can be easily built in few minutes using low-cost items: yoga mat, cotton wool, forceps, needle-driver, scalpel, 0 silk suture, chiba needle, small pebble (1 cm ca) and a few kidney-shaped tomatoes. The yoga mat is fold in half, sutured with silk, placed on the operating table, and thanks to the friction created between the mat and sheet underneath there is no need for other fixating methods. Once placed inside the yoga mat, the tomato is held still in the position by the cotton wool, which is placed around the vegetable. The tomato imitates the real renal structure. Therefore is ideal for this use, and there is no need for liquid-contrast enhancement. The goal is achieved when the operator manages to move the pebble with chiba needle during pulsed fluoroscopy. The model was tested 3 times by 3 endourologists and by 10 residents in training with no experience as first operators. A 7-items questionnaire (1-10 rating scale) was administered to the participants in order to evaluate the utility of the model. Trainees' kidney access time (KAT) and radiation time (RT) were assessed at the first use and after 1 hour of training (circa 15 attempts to reach the target per resident). RESULTS: The model allowed residents' significant reduction of the KAT and RT. KAT passed from 114 (144.25-89) to 72.5 (97.25-49.5) seconds (P = .04) while RAT passed from 82 (89.75-56) to 51.5 (60.25-35.75) seconds (P < .001). The residents particularly appreciated the high-fidelity reproduction of the anatomy that the model offers, and its' usefulness for learning the puncturing technique, giving it 8.5 and 10 points, while the same items were rated 7.7, and 9.3 by the experts, respectively. Trainees felt that their skills could be improved by using this model. The main issue was finding the materials mimicking the real-life tissues and their different characteristics. CONCLUSIONS: TOMATO model might be a helpful and creative way to start learning the steps of kidney puncturing using low-cost materials and we believe its' strength is being easily reproducible in all urology units.

Is there a "curative" role of radiotherapy for clinically localized hormone refractory prostate cancer?

Whether definitive radiotherapy (RT) is still an option for patients with clinically prostate-confined prostate cancer treated with androgen deprivation (AD) alone who develop a rising prostate-specific antigen (PSA) is not clear. In this retrospective series, we report the outcome of 29 such patients treated with "curative" radiotherapy at our institution between 1991 and 2000. At initial diagnosis, all patients had evidence of prostate-confined disease and for several reasons underwent AD alone. Afterward all patients developed rising PSA, but again, without clinical evidence of distant/pelvic node disease. All underwent RT with curative intent up to 70 Gy (66 to 76 Gy). Median follow-up after radiotherapy is 33.1 month (range: 7-134.2 months). For living patients, minimum and median follow-ups are 30.4 and 55.4 months, respectively. Twenty-three patients (79%) developed overt clinical disease, most of which (19/23, 83%) involved distant sites, whereas isolated locoregional failure was observed in only 4 patients (4/23, 17%). The estimates of locoregional control rate (LRC), actuarial incidence of distant metastases, and overall survival at 5 years are 89 +/- 7%, 68 +/- 9%, and 28 +/- 9%, respectively. Although we were unable to find any predictor of LRC at univariate analysis, patients with low Gleason score at diagnosis, lower PSA at RT, lower risk category and advanced age were less likely to develop distant disease. RT has a palliative role, because most patients with still presumed localized hormone refractory prostate cancer will develop distant metastases. A subset of patients, those with more differentiated tumor at diagnosis and with pre-RT PSA less than 20 ng/mL, might be considered for a more aggressive locoregional approach.

Anatomic variations due to radical prostatectomy. Impact on target volume definition and dose-volume parameters of rectum and bladder.

BACKGROUND AND PURPOSE: A quantitative estimate of the impact of prostatectomy on pelvic anatomy is unavailable, even if it would be an important prerequisite for a precise definition of clinical target volume (CTV) in post-prostatectomy radiotherapy. The purpose of this study was to investigate the impact of prostatectomy on the definition of CTV, on the position of bladder and rectum and their implications for three-dimensional conformal radiotherapy (3-D CRT). PATIENTS AND METHODS: Six patients eligible for radical retropubic prostatectomy were considered. Each patient underwent a planning CT between 1 week and 1 month before surgery (CTpre), and then CT was repeated in the same positioning 1-2 months after surgery (CTpost). For each patient the CT(pre/post) scans were matched; rectum, bladder and CTV were contoured on both CT scans for each patient by one observer. Two different CTVs were contoured: CTV1: prostate + seminal vesicles in CTpre; prostate + seminal vesicles surgical bed in CTpost; CTV2: prostate in CTpre; prostate surgical bed in CT(post). After image registration, the contours of rectum, bladder and CTV1/2 drawn on CTpost were transferred on CTpre. The corresponding planning target volumes (PTVs) were generated, and for each PTV, a conformal four field technique using 18-MV X-rays was planned. The volumes of CTV1, CTV2, PTV1, PTV2, rectum and bladder pre- and post-surgery were compared. Differences in 3-D position of these structures before and after surgery were analyzed by beam's eye view (BEV) images. Pre- and post-surgery dose-volume histograms (DVHs) of rectum and bladder were compared together with the fraction of rectum/bladder receiving at least 95% of the ICRU dose (V95), the treated volume (TV, body included in the 95% isodose) and the irradiated volume (IV, body included in the 50% isodose). RESULTS: For both CTV1 and CTV2, the volumes were significantly reduced after prostatectomy (average reduction around 30 cm3 for both; range 0-60 cm3). This reduction was mainly due to a more caudal definition of the cranial edge of CTV after prostatectomy (average difference for CTV2: 1.5 cm; range 0-2.5 cm). Concerning the bladder, a systematic posterior shift of the bladder base (average: 1.5 cm) was found and was correlated with a significant reduction of V95 for bladder (around 10 cm3; p = 0.03). V95 of the rectum, TV and IV also resulted to be significantly lower after surgery. The average reduction of V95 for the rectum was relatively small (2.5 cm3 of rectal wall). CONCLUSION: The impact of prostatectomy on CTV definition is high. A significant reduction of CTV, PTV, TV and IV may be expected after surgery with a consequent reduction of the portions of rectum/bladder irradiated with adjuvant radiotherapy.