Is there a role for transrectal microwave hyperthermia of the prostate in the treatment of abacterial prostatitis and prostatodynia? [Clinical application of PPC for nonspecific chronic prostatitis]. Transurethral microwave thermotherapy for nonbacterial prostatitis: a randomized double-blind sham controlled study using new prostatitis specific assessment questionnaires. Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000. Antimicrobial prophylaxis for transrectal prostatic biopsy: a prospective study of ciprofloxacin vs piperacillin/tazobactam. French multicenter randomized double-blind placebo-controlled trial on nebulized amiloride in cystic fibrosis patients. The Amiloride-AFLM Collaborative Study Group. Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial. Combination antibiotic susceptibility testing to treat exacerbations of cystic fibrosis associated with multiresistant bacteria: a randomised, double-blind, controlled clinical trial. A high-efficiency microwave thermoablation system for the treatment of benign prostatic hyperplasia: results of a randomized, sham-controlled, prospective, double-blind, multicenter clinical trial.
Transrectal microwave hyperthermia of the prostate was administered to 54 patients with chronic abacterial prostatitis or prostatodynia, who failed to respond to several courses of conventional therapies. Hyperthermia was delivered in 60-min long sessions with three randomly chosen regimens (1 session/week for 4 weeks; 1 session/week for 6 weeks; 2 sessions/week for 3 weeks). A prostatic temperature of 42.5 +/- 0.5 degrees C was maintained throughout the entire duration of each session. Patients were assessed pre- and postoperatively by scoring of subjective symptoms, uroflowmetry with flow nomograms, determination of residual urine volume, and transrectal ultrasonography of the prostate. At the long-term follow-up, the subjective symptom score was significantly improved in all patients. Fifty percent of the patients also reported an improvement of life quality, 47% reported their condition unchanged, and 3% reported deterioration, despite therapy. Urodynamic parameters improved but did not reach statistical significance. No major complications were encountered. Our preliminary data indicate that transrectal microwave hyperthermia of the prostate is a safe therapy that can be beneficial as a second line treatment in selected patients with recurring symptoms of abacterial prostatitis or prostatodynia, which do not respond to medical therapy. The clinical effectiveness of PPC, amino acid preparation, on nonspecific chronic prostatitis was evaluated by the double-blind test method. A mixture of two pollen extracts which has been widely employed for the treatment of chronic prostatitis was used as a control. Neither antibiotics nor anti-inflammatory drug was administered during the investigation. A total of 76 cases was reported from six facilities but 14 of them were excluded or dropped out. In 32 cases in the PPC group, subjective symptoms such as discomfort after urination, discomfort in the perineal region, pollakisuria, sense of residual urine and dysuria were improved in 50.0 approximately 61.9% and 70.0 approximately 83.3% after 2- and 4-week administrations, respectively. Similar results regarding each subjective symptom were obtained in 30 cases of the control group and there was no significant difference between the two groups. In the overall clinical effectiveness concerning subjective symptoms, the effective rate including excellently, moderately and slightly effective was 81.3% with PPC and 83.3% with control drug. However when the effective rate was limited to excellently and moderately effective, PPC was slightly superior to the control drug (50.5% versus 36.7%). In regard to prostatic tenderness by the digital examination, both PPC and control drug induced relatively good improvement after 2-week administration. The degree of improvement, however, was not increased in the subsequent 2 weeks. Sclerotic change of the prostate was poorly recovered in both groups even after 4-week treatment. Swelling of the prostate was alleviated in 12.5% of the control group after 2 weeks and in 31.8% after 4 weeks.(ABSTRACT TRUNCATED AT 250 WORDS) We investigated the effectiveness and durability of transurethral microwave thermotherapy in the treatment of chronic nonbacterial prostatitis using 2 new prostatitis specific assessments in a randomized, double-blind, sham controlled trial.
                Patients with nonbacterial prostatitis were randomly assigned to receive either transurethral microwave thermotherapy or sham therapy. Patients were assessed using a symptom severity index and symptom frequency questionnaire. These 2 new prostatitis symptom assessment tools were validated by applying them to 30 similar patients without prostatitis. All nonresponders received transurethral microwave thermotherapy at 3 months and were reassessed at 6 months. Long-term followup of the responder group averaged 21 months.
                The symptom severity index and symptom frequency questionnaire were confirmed to be valid for symptom assessment in prostatitis patients. The transurethral microwave thermotherapy group benefited from therapy compared to the sham group. Of the sham group 50% had a favorable response after subsequent transurethral microwave thermotherapy. The 7 responders in the treatment group continued to improve during the subsequent 21 months.
                Transurethral microwave thermotherapy appears to be an effective, safe and durable treatment for some patients with nonbacterial prostatitis unresponsive to traditional therapy. 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. To compare the efficacy of short-term parenteral prophylaxis with piperacillin/tazobactam (P/T) with long-term oral prophylaxis with ciprofloxacin in preventing infective complications after transrectal prostatic biopsy (TPB).
                Patients scheduled for TPB were randomized to receive P/T (2250 mg intramuscular) twice daily for 2 days (Group 1), or ciprofloxacin (500 mg orally) twice daily for 7 days (Group 2), beginning on the evening before the procedure in both groups. All patients received a 100-mL phosphate enema 3 h before TPB. Evaluation included self-recording of body temperature in the 3 days after TPB, and culture of mid-stream urine (MSU) samples taken before and 3 and 15 days after TPB. Patients with indwelling urethral catheters or taking antibiotics or immunosuppressive drugs were excluded, as were patients with positive MSU cultures before TPB.
                Of the 138 evaluable patients, 72 received parenteral P/T and 66 oral ciprofloxacin. Bacteriuria (> 105 c.f.u./mL) after TPB occurred in two of 72 (2.8%) patients in Group 1 and in three of 66 (4.5%) patients in Group 2; this difference was not statistically significant (P > 0.1). However, of the five patients with bacteriuria, two were symptomatic and both were in Group 2. Pyrexia occurred in only one patient in Group 2 with symptomatic urinary tract infection, and required hospitalization. No other patient reported a body temperature openface> 37.5 degrees C or drug-related side-effects.
                This prospective study showed that short-term prophylaxis with P/T was associated with a low rate of asymptomatic bacteriuria, requiring no further treatment, whereas although the rate was similar on long-term prophylaxis with ciprofloxacin patients required further treatment, with one needing hospitalization. We recommend short-term prophylaxis with P/T despite its disadvantages of cost and parenteral administration. The effect of amiloride, a sodium channel blocker, has been evaluated in a multicenter randomized double-blind placebo-controlled trial in cystic fibrosis patients more than 5-years-old (n = 137) whose forced vital capacity (FVC), forced expiratory volume in 1 sec (FEV(1)), and forced mid-expiratory flow (FEF(25-75)) were not below 50%, 50%, and 30% of reference values, respectively. Patients were randomly allocated to two parallel groups. Sixty-four patients were chronically colonized with Pseudomonas aeruginosa; they received either amiloride or placebo as a nebulized solution three times daily for 6 months. Routine treatments were continued. Patients chronically colonized with Pseudomonas received nebulized colimycine twice a day for a month during the third and sixth months of treatment. Bronchopulmonary exacerbations were treated in the usual way. The effects of the amiloride treatment were assessed at the end of the 6-month treatment period. The effects on FVC and secondarily on FEV(1), FEF(25-75), the number of days on antibiotic therapy, the Shwachman score, a nutritional index (weight/height(2)), the change in sputum bacterial flora, and nocturnal cough were assessed. For the patients not chronically colonized with Pseudomonas, the effect of the treatment was also evaluated by counting chronic colonizations with pathogens appearing during the trial period. The present study failed to demonstrate any significant benefit of amiloride over placebo on FVC, FEV(1), and the other secondary endpoints in the studied population. Neither the chronically colonized, nor the noncolonized patients benefited. The confidence intervals of the differences between treatment groups indicated small differences that were most likely of no clinical significance. Complementary analyses taking into account the gender, the type of mutation, the subpopulations whose FVC and FEV(1) were below 80% of normal values at the beginning of the study, and also patients less than 10 years old, did not show any statistically or clinically significant improvements following amiloride therapy.
                Copyright 2000 Wiley-Liss, Inc. 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. We did a randomised, double-blind, controlled clinical trial to prospectively assess whether use of combination antibiotic susceptibility testing improved clinical outcomes in patients with acute pulmonary exacerbations of cystic fibrosis who were infected with multiresistant bacteria.
                251 patients with cystic fibrosis who were chronically infected with multiresistant gram negative bacteria gave sputum at 3-month intervals for conventional culture and sensitivity tests and for combination antibiotic susceptibility tests using multiple combination bactericidal antibiotic testing (MCBT). Patients who developed an exacerbation of pulmonary disease were randomised to receive a 14-day course of any two blinded intravenous antibiotics chosen on the basis of either results from conventional sputum culture and sensitivity testing or the result of MCBT. The primary outcome was time from randomisation until the patient's next pulmonary exacerbation. Analysis was by intention-to-treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN60187870.
                132 patients had a pulmonary exacerbation and were randomised during the 4.5-year study period. The time to next pulmonary exacerbation was not prolonged in the MCBT-treated group (hazard ratio 0.86 in favour of the conventionally-treated group, 95% CI 0.60-1.23, p=0.40). There was no difference between the groups in treatment failure rate. After 14 days of intravenous antibiotic therapy, changes in lung function, dyspnoea, and sputum bacterial density were similar in both groups.
                Antibiotic therapy directed by combination antibiotic susceptibility testing did not result in better clinical and bacteriological outcomes compared with therapy directed by standard culture and sensitivity techniques. The non-bactericidal effects of antibiotic therapy might play an important part in determining improvement in patients with cystic fibrosis pulmonary exacerbations. To determine the effectiveness, safety, and impact on patient quality of life (QOL) of a novel transurethral microwave thermoablation system for the treatment of benign prostatic hyperplasia (BPH).
                A total of 169 patients with BPH were randomized to undergo a 1-hour microwave (n = 125) or sham (n = 44) procedure using the Urologix Targis thermoablation system on an outpatient basis, without general or regional anesthesia. Symptoms, flow rates, and QOL scores were determined before the study procedure and periodically thereafter up to 6 months.
                Mean American Urological Association (AUA) score in the microwave group diminished 50% (P <0.0005) by the 6-month evaluation (10.5, 95% confidence interval [CI] 9.2 to 11.8) compared with baseline values (20.8, 95% CI 19.8 to 21.9). The sham group also exhibited lower postprocedural AUA scores; however, the magnitude of the postprocedural decline in AUA score in the microwave group was significantly greater (P <0.01) than that in the sham group. Half the microwave group had an AUA score of less than 9 by 6 months, and the decrease in symptoms was similar among patients with initially moderate versus initially severe symptoms. Mean peak urinary flow rate (Qmax) in the microwave group increased 51% (P <0.0005) by 6 months to 11.8 mL/s (95% CI 10.7 to 13.0) versus a pretreatment value of 7.8 mL/s (95% CI 7.4 to 8.2). The magnitude of the postprocedural increase in Qmax was significantly greater in the microwave than the sham group (P <0.05). In nearly half the microwave group (47%), Qmax increased 50% or more by 6 months compared with 24% of the sham group. Microwave treatment resulted in a significantly greater (P <0.05) positive impact on patient QOL than did the sham procedure. By 6 months, the QOL score in microwave-treated patients (2.2, 95% CI 1.9 to 2.4) averaged 48% lower (P <0.0005) than that at baseline (4.2, 95% CI 4.0 to 4.4). Significantly greater durability of treatment effects was also evident with microwave than with sham treatment, as judged by the higher proportion of microwave-treated patients (98.4%) requiring no further treatment during the 6-month study period versus 83.3% of sham control patients (P <0.0005). Microwave treatment was well tolerated, and complications were generally minor, readily manageable, and transitory.
                The microwave thermoablation system proved to be an effective and safe treatment modality for BPH, with a positive impact on patient QOL.
The treatment trials are few, weak methodologically, and involve small sample sizes. The routine use of antibiotics and alpha blockers for chronic abacterial prostatitis is not supported by the existing evidence. The small studies examining thermal therapy appear to demonstrate benefit of clinical significance and merit further evaluation. Additional treatment trials are required and they should report important patient characteristics (e.g., race), study design details and utilize clinically relevant and validated assessment measures.