Development of Feedback Microwave Thermotherapy in Symptomatic Benign Prostatic Hyperplasia.

Abstract: The purpose of this thesis was to evaluate ProstaLund Feedback Treatment® (PLFT®) and the CoreTherm® device with regard to biophysics, mechanisms of action, treatment indications, additional techniques, efficacy and safety in the treatment of patients with benign prostatic hyperplasia (BPH). The application of two biophysical equations in the PLFT software is explained. The calculations provide the intraprostatic ?blood flow index? and amount of accumulated coagulation necrosis during treatment. The accuracy of the ?cell kill? calculations is compared to gadolinium-enhanced magnetic resonance imaging (MRI) and histology. The accumulated ?cell kill? monitored on-line during PLFT is considered a useful tool for helping the doctor to tailor the individual ?thermal dose? to each patient. The clinical efficacy, 1 and 5 years after PLFT and Trans-urethral Resection of the Prostate (TURP), is compared showing no statistically significant differences. Serious adverse events were more frequent after TURP. Expanded treatment indications for PLFT, to including patients with persistent urinary retention and patients with heavily enlarged prostates (>100 g), were studied in a retrospective survey and in a prospective randomized multicentre study comparing PLFT with surgery (TURP and open surgery). Responder rate after PLFT was close to 80% and statistically equivalent to surgery after 6 months. Serious adverse events were less frequent after PLFT. The intraprostatic blood flow works like a heat sink by transporting heat away from the treatment area during thermotherapy. This is the explanation for the unpredictable outcome and frequent treatment failures described after low-energy transurethral microwave thermotherapy. High-energy TUMT can compensate for this in many ways but results in significant patient discomfort from micturition urge, burning sensations and pain. A new device, the Schelin Catheter®, makes it possible to inject and infiltrate the prostate by the transurethral route. Injections in several locations with local anaesthetics containing epinephrine have a twofold aim: 1) to minimize the intraprostatic blood flow and 2) to achieve good analgesia. Treatment time was reduced by 50% and the total energy required was reduced by 60% when using this technique. The effects of the epinephrine on the intraprostatic blood flow were also verified with positron emission tomography, [15O]H2O-PET. The results in this thesis show that the efficacy, safety and methodological improvements of PLFT now make it a challenger to surgery (TURP and open surgery) as a convenient, office based and more available option. This truly minimally invasive treatment is an attractive option for patients that can replace surgery for the majority of patients with clinical BPH. It also reduces the cost to the taxpayer

A new technique of bladder neck reconstruction during radical prostatectomy in patients with prostate cancer

ABSTRACTPurpose:To evaluate continence after radical prostatectomy in prostate cancer patients, in whom a new method of the bladder neck reconstruction (BNR) using deep dorsal stitch was implemented (deep single stitch through all bladder layers directly dorsal to the bladder opening after “tennis racket” reconstruction) and to provide justification for its use by means of anatomical study in cadavers.Material and Methods:Open radical retropubic prostatectomy was performed in 84 patients: 39 patients with a new BNR method used to improve continence and control group of 45 patients with standard “tennis racket” BNR. Median follow-up was 14 months in control group and 12 months in study group. Continence recovery was accessed early postoperatively and every 3 months thereafter. Anatomical study was performed on 2 male fresh cadavers reproducing two different BNR techniques to clarify any underlying continence related mechanisms.Results:Patients with new BNR achieved full continence significantly faster (p=0.041), but the continence rates after 12 months were similar between groups. The severity of incontinence up to month 9 was significantly reduced in BNR group. The anastomotic stricture rate was not affected. Applying new BNR to the cadaver model revealed effects on early continence, namely presence of proximal passive closure mechanism in area of bladder neck.Conclusions:Continence in patients with the new BNR method using deep dorsal stitch recovered significantly faster. Moreover, a reduced grade of residual incontinence was documented. The effect was non-significant at month 12 of follow-up, meaning that only early effect was present.</sec

Five-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study.

To compare the efficacy and safety of transurethral microwave thermotherapy (TUMT) with ProstaLund Feedback Treatment, using the CoreTherm device, with transurethral resection of the prostate (TURP) 5 years after treatment. METHODS This prospective, randomized, multicenter study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to TUMT or TURP in a 2:1 ratio. Patients were followed up at 3, 6, 12, 24, 36, 48, and 60 months after treatment. The intermediate results at 12 and 36 months have been previously reported. The treatment outcome at 5 years was evaluated with the International Prostate Symptom Score (IPSS), quality of life question (QOL), peak urinary flow rate (Qmax), postvoid residual urine volume, and prostate volume. The CoreTherm device differs from other microwave devices in that the intraprostatic temperature is constantly measured during the procedure to guide the treatment. RESULTS Of the 154 patients, 66% completed the 60 months of follow-up. Statistically significant improvements in the TUMT and TURP groups were observed for IPSS, QOL, and Qmax at 60 months. The average values for the TUMT group were an IPSS of 7.4, QOL score of 1.1, and Qmax of 11.4 mL/s. The values for the TURP group were IPSS of 6.0, QOL score of 1.1, and Qmax of 13.6 mL/s. No statistically significant differences were found in any of these variables between the two treatment groups. In the TUMT group, 10% needed additional treatment versus 4.3% in the TURP group. CONCLUSIONS The clinical outcome 5 years after TUMT using the CoreTherm device was comparable to the results seen after TURP. The safety of TUMT using the CoreTherm device compared favorably with that of TURP. (c) 2007 Elsevier Inc