A randomized study comparing high-energy TUMT to TURP: quality-of-life results.

PURPOSE: To evaluate the impact of high-energy transurethral microwave thermotherapy (TUMT) and transurethral prostatic resection (TURP) on quality of life (QoL) in patients with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 147 patients with BPH were randomized to receive either high-energy TUMT treatment (Prostasoft 2.5) or a TURP and were followed for 1 year. All patients completed a QoL questionnaire to assess perception of urinary difficulties, sexual function, daily activities, psychological well-being, social activities and improvement in QoL. RESULTS: For almost all scales the standardized Cronbach's alpha was adequate. Between the various QoL scales there is a statistically significant correlation except for social well-being and sexual functions. There is also a significant correlation between the QoL scales and age, IPSS and Madsen. For the sexual functions there is only a correlation with age. A significant difference in improvement in favor of the TURP group was observed in general perception of urinary difficulties and activities of daily living. However, no difference between the groups was observed for the QoL scale measuring experienced improvement. The sexual function is not influenced by both treatment modalities. Both groups have a significant improvement in clinical outcome at all points of measurement. TURP has a better clinical outcome. CONCLUSION: Both TUMT and TURP have a significant positive effect on various aspects of QoL. In particular, perception of urinary difficulties and activities of daily living are positively influenced by both treatments. TURP, however, has a greater impact than high-energy TUMT.

Lower-energy thermotherapy in the treatment of benign prostatic hyperplasia: long-term follow-up results of a multicenter international study.

The purpose of the present study was to evaluate the long-term results of lower-energy transurethral microwave thermotherapy (TUMT) and to determine predictors for a favorable treatment outcome in an international multicenter study. A total of 1092 patients treated between April 1990 and September 1993 in 6 different centers in different countries were evaluated. All patients were treated in a nonblinded, noncontrolled fashion with the Prostatron thermotherapy device using the lower-energy treatment protocol Prostasoft 2.0. Collected data included voiding parameters, Madsen symptom scores, retreatments, types of retreatment, and dates of retreatment. Instrumental retreatment served as the end point for further evaluation. The average age of our patients was 67 years. At baseline the average uroflow rate was 8.7 ml/s. After treatment the improvement in uroflow was 2-3 ml/s. This was maintained for up to 5 years after treatment for the patients remaining in follow-up. The overall improvement in the Madsen symptom score was 5-6 points for these patients. There was no significant difference between the different centers. During follow-up, however, the number of patients remaining in follow-up decreased rapidly. The absolute instrumental retreatment rate appeared to be 26%; however, when patients no longer in follow-up were taken into account, the calculated retreatment rate was 39.6% (Kaplan-Meier survival analysis). Patients undergoing retreatment were younger at baseline and had a higher Madsen score, a bigger prostate, and a greater postvoid residual. No major complication was seen. Lower-energy TUMT gives a sustained objective and subjective improvement in patients with moderate symptoms and a low-grade bladder outflow obstruction. Patients with bigger prostates, severe symptoms, low rates of maximal uroflow, and large residuals are prone to have a higher degree of prostatic obstruction and are not the ideal candidates for this treatment. The absolute instrumental retreatment rate after 5 years was 26%. Moreover, no significant international difference in treatment outcome was found.

Can histopathology predict treatment outcome following high-energy transurethral microwave thermotherapy of the prostate? Results of a biopsy study.

BACKGROUND: Despite good results of high-energy transurethral microwave thermotherapy (TUMT) in the treatment of benign prostatic hyperplasia, it is still difficult to predict the response to treatment on an individual basis. Besides clinical baseline parameters, intrinsic histological parameters are suggested to play a role in the response variance after TUMT. In this study we analyzed histological parameters (vessel density and epithelium-stroma (E/S) ratio) in patients who were selected for high-energy TUMT and related these parameters to clinical outcome. METHODS: We treated 42 patients with high-energy TUMT, who prior to treatment agreed upon ultrasonographic investigation of the prostate in combination with biopsies of the peripheral and transitional zones of the prostate. For all separate biopsy locations, the histological stained prostate slides were morphometrically quantified with computer assistance and analyzed for E/S ratio and vessel density. Response to treatment was measured by using standardized response evaluation criteria and was correlated with histological outcome. RESULTS: The E/S ratio in the inner gland biopsies tended to be higher in the good response group compared to the very poor responders. Furthermore, a clear trend was seen towards a lower vessel density in good responders. Large prostates and prostates with a high E/S ratio responded well to the high-energy thermotherapy. CONCLUSIONS: Histopathological parameters of the prostate tend to be moderately predictive for clinical response in this research population. Poor responders appeared to have a somewhat higher vessel density in all prostate biopsy sides, and there was also a trend towards a lower E/S ratio in these patients.

Results of high-energy transurethral microwave thermotherapy in patients categorized according to the American Society of Anesthesiologists operative risk classification.

OBJECTIVES: To evaluate the relation between the American Society of Anesthesiologists (ASA) classification and response to transurethral microwave thermotherapy (TUMT) in patients with lower urinary tract symptoms and benign prostatic hyperplasia (BPH). METHODS: Two hundred forty-seven patients with symptomatic BPH treated with high-energy TUMT were scored retrospectively for ASA status. Student's t test was used to determine differences in improvement at each point of follow-up between patients classified as ASA 1 or 2 and patients classified as ASA 3 or 4. Logistic regression analysis was performed to assess the predictive value of ASA status for response using the World Health Organization response evaluation criteria for International Prostate Symptom Score, maximal flow rate, and urodynamic obstruction. RESULTS: There was a significant improvement in objective and subjective parameters at 12, 26, and 52 weeks of follow-up in both ASA 1 and 2 patients and ASA 3 and 4 patients. There was no difference in objective and subjective improvement between both groups at each point of follow-up. Objective and subjective improvement in ASA 3 and 4 patients with cardiovascular disease and ASA 3 and 4 patients with noncardiovascular disease was the same, although patients with cardiovascular disease received less energy during TUMT. Using logistic regression analysis, ASA classification was not predictive of response after high-energy TUMT. CONCLUSIONS: There is no relation between ASA classification and outcome after high-energy TUMT. Because these patients are considered at high risk of perioperative complications and postoperative morbidity, TUMT could contribute considerably to the treatment of BPH in this specific group of patients.

Sexual function following high energy microwave thermotherapy: results of a randomized controlled study comparing transurethral microwave thermotherapy to transurethral prostatic resection.

PURPOSE: We evaluate changes in sexual function in patients treated with high energy transurethral microwave thermotherapy compared to transurethral resection of the prostate. MATERIALS AND METHODS: A total of 147 patients randomized to undergo transurethral microwave thermotherapy or transurethral resection of the prostate were asked to complete a self-administered questionnaire evaluating sexual function before, and 3 and 12 months after treatment. The questionnaire dealt with such items as social status, libido, quality of erection, ejaculation and overall satisfaction of sexual functioning. RESULTS: There was a statistically significant improvement of micturition in both groups. The improvement in the transurethral prostatic resection group was significantly better than in the transurethral microwave thermotherapy group. Antegrade ejaculation occurred at 3 months following treatment in 27% of the transurethral prostatic resection group compared to 74% of the transurethral microwave thermotherapy group and at 1 year in 37 and 67%, respectively. Significantly more patients undergoing transurethral prostatic resection (36%) had changes in sexual function compared to the transurethral microwave thermotherapy group (17%). The transurethral microwave thermotherapy group was more satisfied with the sex life. Of these patients 55% graded sex as very satisfying compared to 21% in the transurethral prostatic resection group. The severity of symptoms was not correlated with sexual function in this study. In general, older patients had sexual dysfunction more often, while younger patients had pain during sexual activities more frequently. CONCLUSIONS: Although clinically less effective, high energy transurethral microwave thermotherapy is a better therapeutic option than surgery for patients who want to preserve sexual function. In particular ejaculation is often preserved after transurethral microwave thermotherapy while there is significant deterioration following transurethral prostatic resection. In general, older patients have greater sexual dysfunction.

How to select patients for high-energy transurethral microwave thermotherapy.

OBJECTIVES: To assist urologists in selecting patients for high-energy transurethral microwave thermotherapy (TUMT) on the basis of baseline characteristics. METHODS: Two hundred forty-seven patients with lower urinary tract symptoms and benign prostatic hyperplasia were treated with high-energy TUMT using the Prostatron device, software version 2.5. To evaluate outcome at 26 weeks, the World Health Organization response evaluation criteria were used. Multiple logistic regression models were created to identify the predictive value of baseline parameters and total amount of energy used. In addition, receiver operating characteristic curve and the best cutoff point for the prediction of a good response of each criterion under the condition of equal "costs" of misclassification to cases and noncases were calculated. RESULTS: For each of the three response evaluation criteria, graphs are presented to determine whether high-energy TUMT using the Prostatron can be justified. Only the total amount of energy delivered by the device has a major impact in all three criteria used. CONCLUSIONS: Graphs have been constructed from our analysis to assist urologists in making clinical recommendations for treatment on the basis of the expected outcome when using high-energy TUMT.

High energy transurethral thermotherapy in the treatment of benign prostatic hyperplasia: criteria to predict treatment outcome.

In this study we analyzed the individual value of baseline parameters to predict the outcome of high energy transurethral microwave thermotherapy in the treatment of patients with lower urinary tract symptoms and benign prostatic hyperplasia. Two hundred and forty-seven patients with symptomatic benign prostatic hyperplasia were treated with high energy microwave thermotherapy using the software 2.5 (Prostatron). Mean age at the time of treatment was 66.3 (s.d. 8.2) y, the mean prostate volume 57.0 (s.d. 25.2) cc and the mean energy applied was 159 (s.d. 40) KJ. Multi variable analysis on baseline parameters was performed to evaluate their predictive value for response using the WHO-response evaluation criteria for IPSS, maximum flow and urodynamic obstruction (linPURR). At 1 y follow-up a 57% increase in maximum flow and a 59% decrease in symptom score was noticed following high energy transurethral thermotherapy. The percentage of good responders varies between 12% and 34% depending on the stratification (IPSS, Q(max) and linPURR), the percentage of intermediate responders in these categories varies between 17% and 60% and the percentage of poor responders varies between 20% and 49%. Independently predictive baseline parameters for poor response were patients' age, prostate size and grade of bladder outlet obstruction (BOO). The total amount of energy delivered during treatment is also correlated with response. For the case selection for high energy transurethral microwave thermotherapy three baseline parameters can be identified which predict response for at least one response evaluation criterium: age, prostate size, grade of bladder outlet obstruction (BOO) and total amount of TUMT-energy. Especially the total amount of TUMT-energy is strongly predictive for all three response evaluation criteria, which suggests an important contribution of other mechanisms such as vascularisation and tissue composition to the outcome of high energy TUMT treatment.

Long-term results of lower energy transurethral microwave thermotherapy.

PURPOSE: We evaluate long-term results of lower energy transurethral microwave thermotherapy (Prostasoft 2.0*) and identify pretreatment characteristics that predict a favorable outcome. MATERIALS AND METHODS: Between December 1990 and December 1992, 231 patients with lower urinary tract symptoms were treated with lower energy transurethral microwave thermotherapy. Subjective and objective voiding parameters were collected from medical records and a self-administered questionnaire. Kaplan-Meier plots were constructed to assess the risk of re-treatment. RESULTS: Of the patients 41% underwent invasive re-treatment within 5 years of followup and 17% were re-treated with medication. The re-treatment-free period was somewhat longer in patients with a peak flow rate greater than 10 ml. per second, a Madsen score 15 or less, a post-void residual volume 100 ml. or less and age greater than 65 years at baseline. Prostate volume did not modify the outcome. No incontinence was caused by transurethral microwave thermotherapy, 8% had recurrent urinary tract infection and 8% had retrograde ejaculation. Only 1 patient had a urethral stricture after transurethral microwave thermotherapy. CONCLUSIONS: At 5 years after transurethral microwave thermotherapy 41% of the patients received instrumental treatment. Patients with a lower Madsen score and lower residual volume, and those with higher peak flow and age were somewhat better responders to lower energy transurethral microwave thermotherapy.

Transurethral resection of the prostate vs high-energy thermotherapy of the prostate in patients with benign prostatic hyperplasia: long-term results.

OBJECTIVE: To evaluate the outcome and durability of high-energy transurethral microwave thermotherapy (HE-TUMT) in comparison with transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Fifty-two patients with BPH and lower urinary tract symptoms were randomized and treated either by TURP (21 patients; mean prostate volume 45 mL, SD 15) or HE-TUMT (31 patients, mean prostate volume 43 mL, SD 12). Long-term results were obtained at a mean (SD) follow-up of 2.4 (0.5) years. RESULTS: During the follow-up, the mean symptomatic improvement stabilized at 56% after TUMT and 74% after TURP. The mean maximum urinary flow rate increased by 62% after TUMT and 105% after TURP. Before treatment, 78% of patients in the TURP group were obstructed according to urodynamic investigation and after treatment, 14% remained obstructed. In the TUMT group, 67% of patients were obstructed before treatment and 33% remained so afterward. Six patients (19%) underwent TURP after TUMT (four after 1 year) and two patients were also treated with medication. One patient underwent a bladder neck incision after TURP to treat bladder neck sclerosis. Three patients were not satisfied with the outcome after the additional TURP. CONCLUSION: Both treatment modalities show good symptomatic and objective results at > 2 years of follow-up. Most re-treatments were performed > or = 1 year after treatment and were based on subjective findings.

The predictive value of baseline variables in the treatment of benign prostatic hyperplasia using high-energy transurethral microwave thermotherapy.

OBJECTIVE: To evaluate the combination of patient age, prostate size, grade of outlet obstruction and total amount of energy, all independent predictive variables of treatment outcome in patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) treated with high-energy transurethral microwave thermotherapy (HE-TUMT), and thus provide nomograms for predicting treatment outcome after HE-TUMT. PATIENTS AND METHODS: Between October 1993 and July 1996, 247 patients with LUTS and BPH were treated with HE-TUMT using the Prostatron device, software version 2.5 (EDAP Technomed, Lyon, France). The World Health Organisation Response Evaluation Criteria were used to evaluate the outcome. Patient age, prostate volume, total amount of energy and grade of outlet obstruction were categorized using the Akaike information criterion (AIC). The probabilities of a good/intermediate vs a poor response at 26 weeks according to the AIC were calculated. RESULTS: Nomograms are presented providing the estimated probability (95% confidence interval) for a good/intermediate response of the evaluation of the International Prostate Symptom Score at 26 weeks by categories of prostate volume, total amount of TUMT energy and age, and of maximum urinary flow rate by categories of bladder outlet obstruction (linear passive urethral resistance ratio, linPURR) and total amount of energy, and of linPURR by categories of prostate volume and total amount of energy. The total amount of energy appeared to have the most impact in the prediction of good/intermediate and poor response in all three response evaluation criteria. CONCLUSIONS: These nomograms may assist urologists in making clinical recommendations for the treatment of men with LUTS and BPH using HE-TUMT.

Case selection for high-energy transurethral microwave thermotherapy.

Transurethral microwave thermotherapy (TUMT) is a minimally invasive outpatient procedure for the treatment of benign prostatic hyperplasia (BPH). Different devices and operating software have been used in various clinical trials. The objective of this study was to identify the possible baseline parameters that could be used to identify the best responders to different microwave devices and treatment programs. Data on three different high-energy thermotherapy devices (Urowave, Prostalund, and Prostatron) were collected and analyzed. At 1 year of follow-up, 166 patients were available for the Prostatron system. In all, 52 had a > or = 50% change in both symptom score and peak flow rate, whereas 114 patients were considered nonresponders. Responders were characterized at baseline by a lower peak flow rate (8.80 versus 10.48 ml/s, P < or = 0.0001) and a larger degree of outlet obstruction as measured by the URA parameter (45.33 versus 36.70 cmH2O, P < or = 0.0300); a larger energy dose was delivered to this group during treatment (173.36 versus 156.40 kJ, P < or = 0.0258). A total of 19 patients were available from the Prostalund cohort. No significant difference was found in the values recorded for baseline parameters between responders (5 patients) and nonresponders (14 patients). Stratification of 143 patients treated with the Urowave resulted in 29 responders (> or = 50% improvement in both Qmax and AUA score) at 6 months of follow-up, with a significant difference being found in the baseline value recorded for peak flow rate (7.0 versus 8.0 ml/s, P < or = 0.026). At 12 months, however, this significance difference could no longer be found. In conclusion, baseline parameters with significant predictive value for a clinical response could be identified for the Prostatron device only. The results of this study further confirm the importance of an extensive laboratory and clinical research program for a fuller understanding of the clinical response obtained with a certain microwave device and a particular treatment software and for provision of the greatest possible advantage from these new alternative treatments. Further exploratory work is required for a better understanding of the role of other parameters such as prostate tissue architecture and vascularity, the microwave frequency, the applicator design, the intraprostatic temperature, and the treatment duration in the clinical response to microwave thermotherapy.

Quality of life assessment in patients treated with lower energy thermotherapy (Prostasoft 2.0): results of a randomized transurethral microwave thermotherapy versus sham study.

PURPOSE: We evaluated the impact of lower energy transurethral microwave thermotherapy on quality of life and quality of sexual function in patients with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 50 patients with BPH were randomized to receive either lower energy transurethral microwave thermotherapy treatment (Prostasoft 2.0) or placebo treatment and followed for 26 weeks after treatment. All patients completed a Madsen symptom score and quality of life questionnaire to assess acceptability, daily activities, psychological well-being, social activities and improvement in quality of life. A sexual function questionnaire was used to assess changes in sexual function after microwave thermotherapy. RESULTS: A significant difference in voiding parameters and symptom score was found between the transurethral microwave thermotherapy and sham groups. Maximum uroflow changed from 9.6 ml. per second at baseline to 13.9 ml. per second and from 9.9 ml. per second at baseline to 9.6 ml. per second at 26 weeks for transurethral microwave thermotherapy and sham groups, respectively. Madsen score improved from 13.2 to 5.3 for the transurethral microwave thermotherapy group and from 11.9 to 9.1 for the sham group. For quality of life measures, a statistically significant difference in favor of the transurethral microwave thermotherapy group was found only for the acceptability item. At baseline and after 26 weeks no statistically significant difference was observed between the 2 groups for Quality of Life measures documenting sexual function. However, almost 20% of patients treated by either transurethral microwave thermotherapy or sham claimed at 26 weeks after treatment that treatment had influenced sexual function. CONCLUSIONS: Although significant changes in objective and subjective parameters were found in patients after lower energy microwave thermotherapy, the change in quality of life was minimal. In addition to the minimal invasiveness of transurethral microwave thermotherapy, preservation of sexual function is appealing.

High-energy transurethral microwave thermotherapy in men with lower urinary tract symptoms.

Since 1993, we have treated patients having lower urinary tract symptoms and benign prostatic obstruction using the high-energy transurethral microwave thermotherapy (HE-TUMT) protocol (Prostasoft; software version 2.5). This study was conducted to investigate the outcome and durability of this treatment. A series of 301 patients with a mean prostate size of 56.4 cc were treated by HE-TUMT if they had a Madsen Symptom Score > or = 8, a maximum flow rate < 15 mL/sec, a voided volume > or = 100 mL, and a postvoiding residual volume < 350 mL. The prostate volume measured by transrectal ultrasonography was > or = 25 cc. Follow-up visits were scheduled at 12, 52, 78, and 104 weeks. Patients were stratified according to the response evaluation criteria set at the 3rd International Consultation on Benign Prostatic Hyperplasia. These response criteria were measured at 12 weeks. At 2 years, there appeared to be a better response in the bigger prostates. Irrespective of relief of outflow obstruction, a good symptomatic response was seen in both good and poor responders. Twenty-two patients were re-treated during the 2-year follow-up period: three underwent bladder neck incision, nine transurethral resection, two laser prostatectomy, one open prostatectomy, and seven additional medical therapy. At 2-year follow-up, HE-TUMT resulted in a durable good outcome in 93% of patients with an objective improvement rate of 42% and a subjective improvement rate of 65%. The best predictor of durability appeared to be the extent of relief of obstruction. Of the 96 bad responders in this group, 14 underwent retreatment, compared with 6 of the 100 good responders.

High energy thermotherapy versus transurethral resection in the treatment of benign prostatic hyperplasia: results of a prospective randomized study with 1 year of followup.

PURPOSE: We compared the outcome of transurethral resection of the prostate and high energy microwave thermotherapy in patients with benign prostatic hyperplasia. MATERIALS AND METHODS: Of 52 patients with symptomatic benign prostatic hyperplasia 21 (mean age plus or minus standard deviation 69.6 +/- 8.5 years) were treated with transurethral resection of the prostate and 31 (mean age 69.3 +/- 5.9 years) were treated with high energy microwave thermotherapy. Patients were assessed using the Madsen symptom score, measurements of voiding parameters, transrectal ultrasound and cystometry, including pressure-flow analyses. Examinations were repeated at fixed intervals for up to 12 months after treatment. RESULTS: After transurethral resection and thermotherapy there was significant improvement in all clinical parameters. At 1 year of followup symptomatic improvement was 78% in the transurethral resection group versus 68% in the thermotherapy group, with improvements in free flow rate of 100 and 69%, respectively. Both groups had significant relief of bladder outlet symptoms. No serious complications occurred in either group, while 1 patient in each group required repeat treatment. CONCLUSIONS: Satisfactory results were obtained after both treatments, with improvements following high energy microwave thermotherapy being in the same range as those after transurethral resection of the prostate.

Current status of thermotherapy of the prostate.

PURPOSE: We reviewed the available data on transurethral microwave thermotherapy in the treatment of patients with benign prostatic hyperplasia (BPH). Furthermore we provide a perspective of this minimally invasive treatment modality. MATERIALS AND METHODS: To our knowledge all previously reported data from clinical trials of transurethral microwave thermotherapy for BPH are reviewed. RESULTS: Transurethral microwave thermotherapy was designed to apply microwave energy deep within lateral prostatic lobes while simultaneously cooling the urethral mucosa, thus enabling an outpatient based anesthesia-free procedure. Lower energy protocols using the Prostraton device provide significant symptomatic improvement and improvement in maximum flow of approximately 35% over baseline. Similar changes are being documented with other transurethral microwave thermotherapy devices. Higher energy protocols using the Prostatron device result in symptomatic improvement similar to that of lower energy protocols, while improvement in uroflowmetry is much more pronounced. However, the latter effect is achieved at the expense of increased morbidity. Second generation protocols have not yet been documented by users of the other thermotherapy devices. CONCLUSIONS: Numerous studies unequivocally support the efficacy and safety of transurethral microwave thermotherapy for treatment of symptomatic BPH. Significant improvement in objective and subjective parameters has been realized with transurethral microwave thermotherapy at multiple centers in the United States and Europe.

Three-year followup of patients treated with lower energy microwave thermotherapy.

PURPOSE: A retrospective study was done to investigate the long-term outcome of patients treated with lower energy transurethral microwave thermotherapy. MATERIALS AND METHODS: A total of 305 patients with lower urinary tract symptoms and benign prostatic hypertrophy underwent transurethral microwave thermotherapy according to a similar protocol at 2 centers. RESULTS: After 3 years of followup 133 patients who had undergone transurethral microwave thermotherapy alone were available for study. During this observation period significant symptomatic improvement from baseline and an improved maximum flow rate of 2.6 ml. per second were noted. Of the patients 125 underwent invasive or medical treatment. CONCLUSIONS: After 3 years of followup lower energy transurethral microwave thermotherapy showed significant and durable improvements in baseline parameters in 52% of the patients.