Transurethral resection vs microwave thermotherapy of the prostate: a cost-consequences analysis.

OBJECTIVE: To compare the costs and outcome of high-energy transurethral microwave thermotherapy of the prostate (HE-TUMT) with transurethral resection of the prostate (TURP), as the former is considered to be the best minimally invasive method for managing lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Between January 1996 and March 1997, 144 patients were randomized to treatment with HE-TUMT (78) using the Prostatron device and Prostasoft 2.5 software (EDAP Technomed, Lyon, France), or TURP (66). At baseline and during the annual follow-up, patients were evaluated by the International Prostate Symptom Score and uroflowmetry (maximum flow rate and postvoid residual volume). Kaplan-Meier survival analyses were used to calculate the cumulative risk of re-treatment. A cost-consequences analysis was performed based on the prospective measurement of healthcare use, with costs expressed as Netherland guilders (NLG). RESULTS: During a 3-year follow-up period, the mean (95% confidence interval) risk of re-treatment was 22.9 (12.5-33.2)% and 13.2 (4.5-21.9)% for HE-TUMT and TURP, respectively (P = 0.215). The mean direct cost of treatment was 3450 (3444-3456) and 6560 (5992-7128) NLG for HE-TUMT and TURP, respectively. The mean total (including re-treatments), discounted (4%) 3-year cost for the HE-TUMT and TURP group was 5300 (4692-5908) and 7800 (7118-8482) NLG, respectively. CONCLUSIONS: In this prospective randomized trial, HE-TUMT and TURP had a comparable 3-year risk of re-treatment. Healthcare expenditure on HE-TUMT, mainly because it is an outpatient treatment, was significantly lower than for TURP.

Biofeedback vs verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy.

OBJECTIVE: To evaluate the comparative effectiveness of electromyographic (EMG) biofeedback with verbal instructions as learning tools of pelvic muscle exercises (PMEs) in the early management of urinary incontinence after radical prostatectomy. PATIENTS AND METHODS: Forty-two consecutive patients (mean age 64 years, sd 4.2), with urinary incontinence after radical retropubic prostatectomy for localized prostate cancer, were randomized to receive biofeedback (group A, 28 men) or verbal feedback (group B, 14 men) as learning tools for PMEs immediately after catheter removal. Group A received 15 sessions of EMG biofeedback (three times weekly, 30 min each) and group B verbal instructions. Evaluation at baseline and 1, 2, 3 and 6 months included the 1-h pad-test and a questionnaire (number of pads/day and incontinence episodes). RESULTS: By the last follow-up, 27 patients had received biofeedback and 15 verbal instructions. Data were analysed according to the intention-to-treat principle. Urine loss as assessed by the 1-h pad-test at baseline, 1, 2, 3 and 6 months was 39, 18, 7, 4 and 3 g for group A and 31, 11, 3, 1 and 0 g for group B, respectively (P > 0.05). The number of pads/day was 3.9, 3.4, 1.2, 0.8 and 0.4 for group A and 3.6, 1.8, 0.9, 0.4 and 0.2 for group B, respectively (P > 0.05). The overall continence rate at 6 months was objectively (urine loss > 1 g) 91% and subjectively (0-1 pad/day) 95%. CONCLUSION: Intensive verbal instructions and biofeedback were both very effective behavioural methods and learning tools for PMEs in the early management of urinary incontinence after radical prostatectomy.

Long-term followup of randomized transurethral microwave thermotherapy versus transurethral prostatic resection study.

PURPOSE: We evaluate the durable effect of high-energy transurethral microwave thermotherapy and transurethral prostatic resection for treatment of patients with lower urinary tract symptoms suggestive of bladder outflow obstruction. MATERIALS AND METHODS: Between January 1996 and March 1997, 155 patients with lower urinary tract symptoms suggestive of bladder outflow obstruction were randomized to receive transurethral microwave thermotherapy (Prostatron*; device and commercial software) (82) or undergo transurethral prostatic resection (73). Initial patient evaluation was performed according to international standards. Patients were followed annually with the International Prostate Symptom Score (I-PSS) and uroflowmetry (maximum flow rate). The Kaplan-Meier survival analysis was used to calculate the cumulative risk of re-treatment, adjusted for loss to followup. RESULTS: A total of 78 patients received transurethral microwave thermotherapy and 66 underwent transurethral prostatic resection. Median followup was 33 months. In the thermotherapy group mean maximum urinary flow rate improved from 9.2 ml. per second at baseline to 15.1, 14.5 and 11.9 ml. per second at 1, 2 and 3 years, and mean I-PSS decreased from 20 to 8, 9, and 12, respectively. In the resection group the corresponding numbers for maximum urinary flow rate were 7.8, 24.5, 23.0 and 24.7 ml. per second at 1, 2 and 3 years, and for I-PSS were 20, 3, 4 and 3, respectively. At 36 months, 14 patients in the thermotherapy and 8 from the resection groups underwent re-treatment, and the cumulative risk was 19.8% (95% confidence interval 10.4% to 29.3%) and 12.9% (4.5% to 21.3%), respectively (p = 0.28). CONCLUSIONS: Transurethral microwave thermotherapy and transurethral prostatic resection achieve durable improvement in patients with lower urinary tract symptoms suggestive of bladder outflow obstruction, while the magnitude of improvement is higher with resection. The repeat thermotherapy is based on failure of therapy whereas repeat resection is based on complications of therapy.

Intra-prostatic vasculature studies: can they predict the outcome of transurethral microwave thermotherapy for the management of bladder outflow obstruction?

BACKGROUND: Blood perfusion regulates intraprostatic temperatures during transurethral microwave thermotherapy (TUMT). We evaluated baseline intraprostatic vasculature, as a predictor of efficacy of TUMT. METHODS: Twenty-two patients, with lower urinary tract symptoms (LUTS) suggestive of bladder outflow obstruction, were treated with TUMT (Prostatron). At baseline, three-dimensional contrast-enhanced power-flow-Doppler prostate ultrasonography (3D-CE-PFD) was performed. Assuming that the percentage of perfused area (PPA) is a realistic measure of blood flow, it was used to quantify intraprostatic vasculature. RESULTS: The median (range) age, prostate size, and energy delivered were 66 years (48-80), 47 cm(3) (30-121), 110 kJ (29-136), respectively. The response was 77% (5 failures). The median (range) PPA was 2.76% (0.7-11.3). No difference in PPA among good and poor responders was detected nor was any correlation between PPA and baseline parameters. CONCLUSIONS: The baseline intraprostatic vascularization, documented by CE-PFD studies, has no predictive value for the efficacy of TUMT. It seems that "static" baseline blood flow does not reflect the "dynamic" thermoregulatory role of blood flow during treatment.

Heat treatment of the prostate: where do we stand in 2000?

Various minimally invasive modalities that are aimed at alleviating lower urinary tract symptoms employ heat-induced ablation of hyperplastic prostatic tissue. Following extensive studies, most of these modalities were eventually abandoned. High-energy transurethral microwave thermotherapy has survived, however, and has gained a firm position as a therapeutic modality, along with transurethral resection of the prostate. Recent research addressed fundamental issues of mode of action of microwave treatment, and revealed the overall efficacy of this treatment, determined new indications, and rendered high-energy transurethral microwave thermotherapy more acceptable to the patients. Insights into intraprostatic vascularization and treatment monitoring were also gained as a result of these global research efforts.

Transurethral microwave thermotherapy in the armamentarium of therapeutic modalities for benign prostatic hyperplasia.

Transurethral microwave thermotherapy (TUMT) has gained a firm place in the spectrum of therapeutic modalities for management of patients with lower urinary tract symptoms suggestive of bladder outflow obstruction. To achieve optimum results following TUMT, intense research focuses on appropriate patient selection, heat-tissue interactions, and modification of technical specifications. Results of TUMT are good to excellent for the majority of patients, but there is a non-negligible number of patients who respond poorly. The selection of favorable candidates for TUMT aims to improve the therapeutic results, and both clinical baseline parameters and intrinsic characteristics of the prostate (histologic composition and vasculature) may influence treatment outcome. TUMT achieves therapeutic response through coagulative necrosis of the hyperplastic tissue, but additional theories have been proposed recently, suggesting that TUMT may cause neural destruction and induce apoptosis. Individualization of the treatment is expected to offer the best results, and because the temperature achieved inside the prostate determines the actual parenchymal necrosis, thermal monitoring during treatment will permit application of microwave energy in a feedback mode. Various microwave devices differ in technical specifications (operating frequency, design of antenna, cooling system), and recently introduced software programs (high-energy protocols, heat-shock strategy, short-duration protocols) aim at better efficacy, providing a more patient-friendly procedure. TUMT has survived the "test of time" that other, initially promising, modalities have failed. What remains to be determined is the maximum benefit that patients and health systems can gain from such a technique.

Predictors of treatment outcome for high-energy transurethral microwave thermotherapy.

BACKGROUND AND PURPOSE: Transurethral microwave thermotherapy (TUMT) is an innovative alternative to transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) suggestive of bladder outflow obstruction (BOO). Although the results are satisfactory for the majority of the patients, a considerable number of patients have an unfavorable outcome. Thus, the identification of features able to predict efficacy of TUMT for individual candidates is an important issue. MATERIALS AND METHODS: The available literature in MEDLINE covering the predictive role of various baseline measures for the outcome of high-energy TUMT was reviewed. Direct comparison among various studies was not possible because of differences in thermotherapy devices, treatment protocols, and the definition of a good response to treatment. RESULTS: Predictive features have been detected only for the Prostatron device. A small prostate volume, a low grade of BOO, and advanced age were independent predictors of poor outcome. The strongest predictive feature was the amount of energy delivered during treatment. Histologic characteristics (epithelial:stromal ratio and microvessel density) have not proved predictive for therapeutic outcome. The role of intraprostatic vascularization, as a regulator of the temperature during treatment, seems to be of the greatest importance, but results have not been presented yet. CONCLUSION: The value of baseline clinical measures for the selection of the best candidates for TUMT is limited at best. Variations in the internal structure of the individual prostate seem to play the most important role in regulating the amount of energy absorbed during treatment, and further research must focus on this item.

Clinical efficacy of a new 30-min algorithm for transurethral microwave thermotherapy: initial results.

OBJECTIVE: To assess the efficacy of a new 30-min algorithm for high-energy transurethral microwave thermotherapy (TUMT, Prostasoft 3.5) in the treatment of men with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia. PATIENTS AND METHODS: A total of 108 men (mean age 66 years) with bothersome LUTS were treated with the new TUMT protocol. All patients were evaluated using a standard assessment at baseline, 6, 12, 26 and 52 weeks after TUMT. The evaluation included the assessment of objective and subjective outcome measures, with a urodynamic evaluation using pressure-flow analysis, and the occurrence of adverse events. RESULTS: The treatment was well tolerated. In general, the International Prostate Symptom Score improved from a mean of 20.0 at baseline to a mean of 9.3 at 6 months after treatment. The maximum urinary flow improved from 9.4 mL/s to 14.6 mL/s at 6 months. The mean duration of catheterization was 17.9 days. The urodynamic evaluation showed a change from the obstructed to the equivocal zone on the Abrams-Griffith nomogram. There were no serious complications. Urgency and frequency were the most frequent side-effects after treatment; these all resolved within 3 months. CONCLUSION: High-energy TUMT using the new high-dose Prostasoft 3.5 protocol appears to be a safe and effective treatment. The faster procedure improves the tolerance of the treatment. The subjective and objective improvements were significant and the treatment-related morbidity low. A longer follow-up is needed to assess the durability of this new treatment protocol.

Tolerability of 3.5 versus 2.5 high-energy transurethral microwave thermotherapy.

PURPOSE: To evaluate the tolerability of high-energy microwave thermotherapy in patients with benign prostatic hyperplasia (BPH) using two different treatment protocols (Prostasoft 2.5 and Prostasoft 3.5). MATERIALS AND METHODS: Pain and discomfort during treatment was evaluated using a visual analog scale in 39 patients undergoing 60-min Prostasoft 2.5 treatment and 41 patients undergoing 30-min Prostasoft 3.5 treatment. The duration of transurethral microwave thermotherapy (TUMT) 3.5 treatment is significantly shorter than TUMT 2.5 treatment. RESULTS: The pain level is significantly higher at the beginning of the Prostasoft 3.5 treatment compared to the Prostasoft 2.5 treatment. The reported pain level becomes similar 10 min into treatment, and remains similar to the end of the 3.5 treatment (at 30 min), when the pain level returns to baseline. The 2.5 protocol patients experience continuously increasing pain until the end of the treatment at 60 min. One minute following termination of treatment, the pain level drops back to the baseline level. No correlation between the level of pain and the baseline subjective or objective voiding parameters was observed. A correlation is also absent between the pain level, age and catheterization time. There only seems to be a weak correlation between the pain level and TUMT energy in the Prostasoft 2.5 treatment group. CONCLUSIONS: Both TUMT 2.5 and TUMT 3.5 are well tolerated. Even though patients undergoing TUMT 3.5 treatment experience more discomfort initially, the ultimate discomfort is similar to the TUMT 2.5 treatment, during the first 30 min. Shortening of treatment time significantly reduces the pain and discomfort experienced by the patient. Pretreatment parameters are not predictors of the pain level experienced.

High energy transurethral microwave thermotherapy for the treatment of patients in urinary retention.

PURPOSE: We evaluated the efficacy of high energy transurethral microwave thermotherapy for treating urinary retention due to benign prostatic hyperplasia. MATERIALS AND METHODS: Between October 1993 and March 1999, 41 patients with urinary retention were treated with high energy transurethral microwave thermotherapy. Initial evaluation consisted of a history, clinical examination, urethrocystoscopy, transrectal prostate ultrasonography and urodynamic investigation with a pressure flow study. Followup visits at 12, 26 and 52 weeks included International Prostate Symptom Score (I-PSS), uroflowmetry and post-void residual urine volume determination. At 26 weeks the urodynamic study was repeated. Kaplan-Meier plots were constructed to evaluate the risk of re-treatment adjusted for patients lost to followup. RESULTS: At baseline median patient age was 74 years and median prostate size was 67 ml. Median 133 kJ. were administered. Nine patients underwent re-treatment and 11 were lost to followup. The re-treatment rate after 1 year was 25% (95% confidence interval 11 to 40). In good responders at 12, 26 and 52 weeks median maximal urine free flow was 15, 11 and 15 ml. per second, post-void residual urine volume was 61, 8 and 35 ml., and I-PSS was 7, 5 and 2, respectively. Quality of life (I-PSS question 8) was 1 at all visits. CONCLUSIONS: In patients with severe co-morbidity transurethral microwave thermotherapy is often the only alternative to an indwelling catheter with obvious quality of life advantages. High energy transurethral microwave thermotherapy appears to be effective in these patients.