Transurethral microwave thermotherapy (Prostatron version 2.5) compared with transurethral resection of the prostate for the treatment of benign prostatic hyperplasia: a randomized, controlled, parallel study. Feedback microwave thermotherapy versus TURP for clinical BPH--a randomized controlled multicenter study. Transurethral microwave thermotherapy versus transurethral resection for symptomatic benign prostatic obstruction: a prospective randomized study with a 2-year follow-up. A randomized controlled trial of transurethral microwave thermotherapy. Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000. Prospective randomized comparison of high energy transurethral microwave thermotherapy versus alpha-blocker treatment of patients with benign prostatic hyperplasia. Transurethral microwave thermotherapy v sham treatment: double-blind randomized study. Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial. Transurethral interstitial laser coagulation of the prostate and transurethral microwave thermotherapy vs transurethral resection or incision of the prostate: results of a randomized, controlled study in patients with symptomatic benign prostatic hyperplasia.
To compare transurethral microwave thermotherapy (TUMT) with urethral cooling in a high-energy protocol (Prostatron version 2.5), with transurethral resection of the prostate (TURP) for the treatment of symptomatic, uncomplicated, urodynamically obstructive benign prostatic hyperplasia (BPH).
                Patients with moderate to severe symptomatic, uncomplicated BPH, unequivocally obstructed as assessed from the Abrams-Griffith nomogram, who were technically suitable for either form of treatment, were randomized into two groups of 30 patients each to undergo either TUMT or TURP. Five efficacy variables, i.e. the American Urological Association (AUA) symptom score, maximum flow rate (Qmax), post-void residual urine volume (PVR), voiding pressure at maximal flow (Pdet max) and prostatic volume determined by ultrasonography (PV) were measured initially and 6 months after treatment using a defined protocol. Complications were recorded during and up to 6 months after the treatment. As the variables were independent, the data were analysed using a paired t-test for each to assess the treatment effect for each group.
                After TURP, all the variables improved significantly; after TUMT, the symptoms improved both clinically and statistically (P < 0.001), with the mean AUA symptom score decreasing from 18.4 to 5.2. However, none of the objective variables improved after TUMT. The energy delivered under software control correlated poorly with prostatic volume (r = 0.322). TUMT had considerably lower morbidity than TURP, but failure of ejaculation occurred in four of 18 sexually active men after TUMT.
                Despite considerable improvement in their symptoms, TUMT using the Prostatron and Prostasoft v2.5 did not alleviate obstruction in patients with BPH. Patients treated using TUMT controlled by this software should be informed of the possibility of ejaculatory dysfunction. To compare the outcome of a microwave thermotherapy feedback system that is based on intraprostatic temperature measurement during treatment (ProstaLund Feedback Treatment or PLFT) with transurethral resection of the prostate (TURP) for clinical benign prostatic hyperplasia (BPH) in a randomized controlled multicenter study. The safety of the two methods was also investigated.
                The study was performed at 10 centers in Scandinavia and the United States. A total of 154 patients with clinical BPH were randomized to PLFT or TURP (ratio 2:1); 133 of them completed the study and were evaluated at the end of the study 12 months after treatment. Outcome measures included the International Prostate Symptom Score (IPSS), urinary flow, detrusor pressure at maximal urinary flow (Qmax), prostate volume, and adverse events. Patients were seen at 3, 6, and 12 months. Responders were defined according to a combination of IPSS and Qmax: IPSS 7 or less, or a minimal 50% gain, and/or Qmax 15 mL/s or greater or a minimal 50% gain.
                No significant differences in outcome at 12 months were found between PLFT and TURP for IPSS, Qmax, or detrusor pressure. The prostate volume measured with transrectal ultrasonography was reduced by 30% after PLFT and 51% after TURP. Serious adverse events related to the given treatment were reported in 2% after PLFT and in 17% after TURP. Mild and moderate adverse events were more common in the PLFT group. With the criteria mentioned above, 82% and 86% of the patients were characterized as responders after 12 months in the PLFT and TURP groups, respectively. The post-treatment catheter time was 3 days in the TURP group and 14 days in the PLFT group.
                The outcome of microwave thermotherapy with intraprostatic temperature monitoring was comparable with that seen after TURP in this study. From both a simplicity and safety point of view, PLFT appears to have an advantage. Taken together, our findings make us conclude that within a 1-year perspective microwave thermotherapy with PLFT is an attractive alternative to TURP in the treatment of BPH. To compare the outcome of transurethral resection of the prostate (TURP) and transurethral microwave thermotherapy (TUMT) on symptomatic benign prostatic hyperplasia (BPH).
                Patients with symptomatic BPH were treated by either TURP (32 patients; mean age 70 +/- 6 years) or TUMT (37 patients; mean age 67 +/- 9 years) and assessed using the Madsen-Iversen symptom score, measurements of urinary free flow rate and post-void residual urine volume, digital rectal examination, transrectal ultrasonography, cystometry and pressure-flow measurement, ultrasonography or intravenous pyelography (IVP) of the upper urinary tract, urine analysis and routine blood chemistry including serum prostate-specific antigen (PSA) level. Examinations were repeated at fixed intervals for up to 24 months after treatment.
                After both TURP and TUMT there was an improvement in symptom score, residual urine volume, free flow rate and infravesical obstruction. The improvements of free flow rate and obstruction were more pronounced after TURP. Serious complications, such as bleeding requiring a re-operation, occurred only in patients who underwent TURP.
                Satisfactory results were obtained after both treatments and the improvements with either treatment lasted for at least 24 months. To establish the short term clinical and urodynamic effect of transurethral microwave thermotherapy (TUMT) in men with symptomatic uncomplicated benign prostatic hyperplasia (BPH) using a randomized controlled trial comparing the treatment with both 'placebo-like' and untreated control groups.
                The study comprised 120 symptomatic patients with BPH who were candidates for transurethral resection and TUMT. They were randomized to one of three groups: group 1 underwent a standard TUMT, group 2 underwent a simulated treatment identical to group 1 but with no emission of microwaves and group 3 received no treatment. The treatment of the first two groups was 'double-blind' and the heat experienced by the patients during treatment was simulated in both. Patients were assessed on entry to the study and 6 months after treatment using an identical protocol to measure the American Urological Association (AUA) symptom score, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), minimum urethral opening pressure (Pmuo) and maximum detrusor pressure (Pdet max).
                In the untreated group there were no clinically or statistically significant changes in the median AUA symptom score, Qmax, PVR, Pmuo and Pdet max. In group 1 the AUA score changed significantly, from 19 to 9.5, but the Qmax, PVR, Pmuo and Pdet max did not. In group 2, the AUA score also changed significantly, from 17.5 to 9.5, but Qmax, PVR, Pmuo and Pdet max did not.
                The untreated control group showed no clinically relevant deterioration or improvement. The standard and simulated TUMT groups showed little clinically relevant improvement in 'objective' variables, while the clinically significant symptom improvement was of a similar magnitude in both groups. Transurethral microwave thermotherapy (TUMT) is an effective therapy for symptomatic benign prostatic hyperplasia (BPH), but the trade-off between the magnitude of clinical improvement and side effects and patient tolerance has limited its appeal to patients and urologists. This study, using the TherMatrx TMx-2000, a TUMT device that directly heats the transition zone to greater than 50 degrees C, has been focused on resolving these issues and developing a truly office-based therapy that is well tolerated with a benign post-treatment course.
                This study was multi-institutional and designed as a blinded, randomized, and sham-controlled trial. A series of 200 patients with an AUA Symptom Index (AUASI) of >12, a peak flow rate of <12 mL/sec, and cystoscopic evidence of BPH were randomized 2:1 (active to sham) and treated in seven physician offices under a Food and Drug Administration-supervised and audited premarket approval protocol. No intravenous sedation was used in any patient. Follow-up for the sham-treatment group was 3 months, at which time, patients could cross over to an active treatment. A total of 119 patients have completed 1-year follow-up.
                The active and sham groups were statistically identical at baseline. The 1-hour total treatment was extremely well tolerated using urethral lidocaine and oral medications; not a single prostate block or parental dose of medication was required. The active-treatment group demonstrated a statistically significant reduction (p < 0.05) in AUASI at 3 months compared with sham treatment, with an AUASI decrease from 22.4 to 12.4 (n = 124) for active v 22.9 to 17 for sham (n = 62). For the 119 patients in the active arm who have reached 12 months, the AUASI has fallen to 10.6 points (47.1% decrease), and the peak flow rate has increased 5.0 mL/sec (58.1%). Postprocedure catheterization was typically 2 or 3 days, and the 16.8% of patients who failed their first voiding trial all voided within 1 week. No major adverse events such as stricture, rectal findings, or ejaculatory changes have been reported.
                This study demonstrates that the TherMatrx TMx-2000 TUMT effectively treats symptomatic BPH in the physician office with minimal morbidity. We compare directly the efficacy and safety of targeted high energy transurethral microwave thermotherapy with alpha-blocker treatment for benign prostatic hyperplasia (BPH).
                In this randomized prospective study 52 patients with symptomatic BPH received terazosin and 51 underwent high energy transurethral microwave therapy with topical anesthesia. Patient evaluation included determination of International Prostate Symptom Score (I-PSS), peak flow rate and quality of life score before transurethral microwave therapy or terazosin and periodically up to 6 months thereafter.
                At 2-week followup the terazosin group transiently exhibited significantly greater improvement than the transurethral microwave therapy group in mean values of all 3 primary efficacy parameters of I-PSS, peak flow rate and quality of life score. At 12 weeks and 6 months this pattern was reversed, and the transurethral microwave therapy group achieved significantly greater improvement than the terazosin group in mean I-PSS, peak flow rate and quality of life score. By 6 months 78.4, 64.7 and 84.3% of the transurethral microwave therapy group demonstrated a 50% or greater improvement in I-PSS, peak flow rate and quality of life score, respectively, compared with 32.7, 9.6 and 40.4% of the terazosin group, respectively. Nine patients in the terazosin group and 1 in the transurethral microwave therapy group withdrew from study because of side effects or lack of treatment efficacy.
                Terazosin afforded more rapid improvement in symptoms, voiding function and quality of life in BPH patients. High energy transurethral microwave therapy offered markedly superior clinical outcomes at 12 weeks to 6 months. Transurethral microwave thermotherapy (TUMT) is a single-session, 1-hour office-based treatment for benign prostatic hyperplasia. A randomized, double-blind study has been conducted at our institutions involving 115 patients who, after satisfying the entry criteria, were randomized in a 2:1 fashion to receive TUMT or a sham treatment. Three months' unblinding revealed both statistically and clinically significant improvement in the efficacy measures for the real treatment compared with the sham. The mean Madsen Symptom Score decreased 55% and the mean peak flow rate increased 58% in the TUMT-treated patients v 28% and 27% in the sham-treated patients (P < 0.001). Also, the TUMT-treated patients improved in mean AUA Symptom Score by 43% v 26% for sham-treated patients (P < 0.01). Reclassification of patients after therapy showed a greater shift to the mild category of AUA Symptom Score: 37% for TUMT patients v 6.5% for sham-treated patients. In addition, prostate-specific antigen elevation to >4 times baseline was noted 1 week after TUMT v no statistically significant change for sham-treated patients. This double-blind study demonstrates that thermotherapy's efficacy is not placebo related and that the mechanism of action is related to thermal ablation of transition zone adenoma. To study the efficacy and safety of a new transurethral microwave thermotherapy device (the Urowave) in the treatment of men with clinical benign prostatic hyperplasia (BPH) in a randomized, double-blind, sham-controlled trial.
                A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association symptom index (AUA SI) of 13 points or more, and a peak flow rate of 12 mL/s or less were enrolled and randomized 2:1 for active versus sham treatment. All treatments were conducted as an outpatient procedure under local anesthesia, with oral sedation and analgesia only. Patients were followed up at 1 week and 1, 3, and 6 months after treatment.
                The treatments were well tolerated, and no patient received general or spinal anesthesia. The AUA SI dropped from 23.6 to 12.7 points at 6 months (P < 0.05) in the active group and from 23.9 to 18.0 points in the sham-treated group (P < 0.05, between-group difference). Statistically significant improvements were also noted for peak flow rate (7.7 to 10.7 mL/s at 6 months for active treatment, 8.1 to 9.8 mL/s for sham treatment, P < 0.05, between-group difference) and for average flow rate. A decrease in AUA SI of more than 30% was achieved in 72% versus 38% of patients (active versus sham treatment, respectively) and more than 50% in 50% versus 19% of patients. In general, active Urowave-treated patients perceived "a lot" of improvement, whereas sham-treated patients perceived "a little" to "some" improvement. More of the actively treated patients had dysuria and urgency after treatment, and ejaculatory dysfunction (e.g., hematospermia) was more common in actively treated patients as well. Secondary urinary retention after removal of the catheter occurred in 8 patients (5.4%).
                The Dornier Urowave transurethral microwave thermotherapy device for treatment of clinical BPH is effective in decreasing symptoms and bother and improving quality of life and flow rate and is superior to sham treatment. Patients perceive a great deal of improvement, independent of their baseline symptom severity. Adverse events are in general transient and mild in nature. Extended follow-up is necessary to document long-term durability of improvements. To compare the efficacy and frequency of complications of transurethral interstitial laser coagulation (ILC) and transurethral microwave thermotherapy (TUMT) with transurethral resection or incision of the prostate (TURP/TUIP) in patients with symptomatic benign prostatic hyperplasia (BPH).
                Forty-eight patients were randomized to undergo ILC, 46 to TUMT and 24 to TURP/TUIP; they were followed for 6 months and the outcome analysed on an intention-to-treat basis.
                At 6 months the symptom scores and maximum urinary flow rate (Qmax) had improved significantly in all groups. At 6 months the mean symptom score was 9.2 in both experimental groups and 6.8 in the control group (P > 0.05); the mean Qmax was 20.6 mL/s in the control group, 16.2 in the ILC group (P > 0.05 vs control) and 13.2 in the TUMT group (P < 0.05 vs. the control group). In the TUMT group patients developing urinary retention afterward had a significantly greater increase in Qmax than those who did not. The types of complications in the three groups varied. Urinary tract infection occurred frequently in the experimental groups, especially after ILC, whereas the 'well-known' complications of TURP occurred in the control group. Overall, 36% in the ILC, 54% in the TUMT and 73% in the control group had no complications (retrograde ejaculation excluded) during the first 6 months. One patient in the TUMT group underwent TURP after 3 months, whereas no patients in the ILC or the con-trol group were re-treated for BPH within the first 6 months.
                In the short term both ILC and TUMT are reasonable alternatives to standard transurethral surgery for symptomatic BPH, where the reduction of symptoms is the primary goal of treatment. However, both ILC and TUMT were associated with morbidity, although the complication profiles differed from those after TURP/TUIP. Both ILC and TUMT seem advantageous in some patients because of the reduced risk of bleeding and the eliminated risk of TUR syndrome, and because TUMT only requires local anaesthesia. Thus, as neither treatment is better in all aspects, the advantages of one technique over the other must be weighed when deciding how to treat each patient.
Microwave thermotherapy techniques are effective alternatives to TURP and alpha-blockers for treating symptomatic BPH in men with no history of urinary retention or previous prostate procedures and prostate volumes between 30 to 100 mL. However, TURP provided greater symptom score and urinary flow improvements and reduced the need for subsequent BPH treatments compared to TUMT. Small sample sizes and differences in study design limit comparisons between devices with different designs and energy levels. The effects of symptom duration, patient characteristics, or prostate volume on treatment response are unknown.