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M L Blute

Publications and source records attributed to M L Blute.

At least 73 records · Page 4Linked to original sources
PubMed1998

Transurethral microwave thermotherapy: what role should it play versus medical management in the treatment of benign prostatic hyperplasia?

Both transurethral microwave thermotherapy (TUMT) and medical management by alpha-blockade or 5-alpha-reductase inhibition are increasingly being considered as alternatives to surgery for treatment of patients with benign prostatic hyperplasia (BPH). We review current evidence supporting the effectiveness and safety of TUMT and medical management. Factors for consideration in appropriately selecting patients for TUMT versus medical management are suggested. Available data indicate that TUMT confers greater long-term benefits than medical management as judged by symptom score and peak urinary flow rate improvements. TUMT-associated morbidity is comparatively low. Alpha-blockade affords more rapid relief than TUMT for patients with BPH; however, other strategies such as the use of temporary intraurethral endoprostheses during the acute post-TUMT recovery period may diminish or abolish the differences in time-course of symptom and flow rate improvement between TUMT and alpha-blockade. 5-Alpha-reductase inhibition with finasteride offers a favorable side-effect profile, although the magnitude of symptom and flow rate improvements is modest, and maximal effects of finasteride do not become manifest until after several months of treatment. As TUMT continues to evolve, increasing attention is being accorded the delivery of high thermal doses and precise targeting of the thermal energy delivered. The development of alpha-blockers with a more favorable side-effect profile continues to be a major focus of investigation. The potential clinical utility of combination therapy with TUMT and alpha-blockade is currently under investigation.

Clinical Trials as Topic↗
PubMed1998

Evidence for autosomal dominant inheritance of prostate cancer.

A family-history cancer survey was conducted on 5,486 men who underwent a radical prostatectomy, for clinically localized prostate cancer, in the Department of Urology at the Mayo Clinic during 1966-95; 4,288 men responded to the survey. Complex segregation analysis was performed to assess the genetic basis of age at diagnosis and the familial clustering of prostate cancer. For the total group, no single-gene model of inheritance clearly explained familial clustering of disease, which could be partly explained by lack of Hardy-Weinberg equilibrium, with an excess of homozygotes. After accounting for deviations from Hardy-Weinberg equilibrium, the best-fitting model that explained the familial aggregation and age at diagnosis was a rare autosomal dominant susceptibility gene, and this model fitted best when probands were diagnosed at <60 years of age. The model predicts that the frequency of the susceptibility gene in the population is .006 and that the risk of prostate cancer by age 85 years is 89% among carriers of the gene and 3% among noncarriers. A strength of our study is its large size, such that genetic models could be fitted within strata defined by the age of the proband. Although the autosomal dominant model was consistently the best model, the parameter estimates differed somewhat (P=.03) across the different age groups, suggesting genetic heterogeneity. Additional evidence that the hereditary basis of prostate cancer is likely to be genetically complex was provided by the following: (1) there was a significantly elevated age-adjusted risk of prostate cancer among brothers of probands, compared with their fathers (relative risk 1.5 [95% confidence interval 1.4-1.7]); (2) the autosomal dominant model predicted an excess of homozygotes, over that predicted by Hardy-Weinberg equilibrium; and (3) the model-predicted risk of prostate cancer among relatives was inadequate when probands were diagnosed at age >=70 years.

Adult↗
PubMed1998

Cancer volume of lymph node metastasis predicts progression in prostate cancer.

Clinical outcome is variable in prostate cancer patients with regional lymph node metastasis. We studied 269 patients who had regional lymph node metastasis at the time of radical retropubic prostatectomy and bilateral pelvic lymphadenectomy at the Mayo Clinic between January 1987 and December 1992. Two hundred fifty-three (94%) patients received androgen deprivation therapy within 90 days of radical prostatectomy. Patients ranged in age from 47 to 79 years (median, 67 years). Median follow-up was 6.1 years (range, 0.3-10.5 years). Nodal cancer volume (size) was measured by the grid-counting method. Cox proportional hazards models were used to determine the impact of numerous clinical and pathologic findings on systemic progression-free survival. Systemic progression was defined as the presence of distant metastasis documented by biopsies or radiographic examinations (abdominal computerized tomography, plain radiographs, or bone scan). Five-year progression-free survival was 90%. In predicting systemic progression using Cox multivariate analysis, only nodal cancer volume added significantly to the model containing the primary cancer variables (Gleason score, cancer volume, and DNA ploidy). The relative hazard rate for a doubling in nodal cancer volume was 1.6 (95% confidence interval, 1.3 to 2.0; p < 0.0001). Spearman rank analysis showed a correlation between nodal cancer volume and Gleason score of the primary cancer, the number of positive nodes, the aggregate length of metastases, and the largest nodal cancer diameter (correlation efficient = 0.37, 0.63, 0.96, and 0.95, respectively). Our data indicate that nodal cancer volume was the most significant nodal determinant of progression to distant metastasis in lymph node-positive prostate cancer patients. We recommend that the diameter of the largest metastasis be evaluated in patients with metastases, because this is a more powerful predictor of patient outcome than current methods, which recommend mere counting of the number of positive nodes.

Aged↗
PubMed1998

Carcinosarcoma and sarcomatoid carcinoma of the bladder: clinicopathological study of 41 cases.

PURPOSE: Carcinosarcoma of the bladder is a rare neoplasm characterized by an intimate admixture of carcinoma and malignant soft tissue neoplasm. The clinical usefulness of separating carcinosarcoma (carcinoma with sarcomatous component) from sarcomatoid carcinoma (carcinoma with spindle cell carcinomatous component) is uncertain, and it comprises the subject of this report. MATERIALS AND METHODS: We reviewed the clinical and pathological records of 10 men and 5 women a mean of 66 years old with carcinosarcoma, and 21 men and 5 women a mean of 66.5 years old with sarcomatoid carcinoma of the bladder, as documented in the files of the Mayo Clinic between 1936 and 1995. RESULTS: Of the 15 patients in the carcinosarcoma group 9 had urothelial carcinoma, small cell carcinoma, 3 had squamous cell carcinoma and 2 had more than 1 type. The sarcomatous component included chondrosarcoma in 3 cases, leiomyosarcoma in 3, malignant fibrous histiocytoma in 3, osteosarcoma in 2, fibrosarcoma in 1, rhabdomyosarcoma in 1 and more than 1 type in 2. All disease was high stage at presentation. Treatment included cystectomy in 11 patients with (4) and without (7) radiation therapy, and transurethral resection in 4 with (1) and without (3) radiation therapy. Mean followup available in 14 cases was 34 months (range 1 to 144). A total of 11 patients died of cancer at 1 to 48 months (mean 17.2) and 2 survived for 8 to 131 months. Of the 26 patients in the sarcomatoid carcinoma group 18 had urothelial carcinoma, 1 had squamous carcinoma, 2 had urothelial carcinoma combined with squamous cell carcinoma and 5 had spindle cells only with no recognizable epithelium. All but 1 case was high stage at diagnosis. Treatment included transurethral resection in 17 patients with (7) and without (10) radiation therapy, including 1 who also received chemotherapy, and only cystectomy in 5, including 2 who also underwent radiation therapy and 1 who also received chemotherapy. Mean followup available in 21 cases was 49 months (range 1 to 420). A total of 17 patients died of cancer at 1 to 73 months (mean 9.8), 1 was alive at 140 months and 3 died of unrelated causes. CONCLUSIONS: Carcinosarcoma and sarcomatoid carcinoma of the bladder are highly aggressive malignancies with a similar outcome regardless of histological findings and treatment. Pathological stage is the best predictor of survival.

Aged↗
PubMed1998

Continent orthotopic urinary diversion in female patients: early Mayo Clinic experience.

OBJECTIVE: To review our initial experience with orthotopic neobladder urinary diversion in female patients. MATERIAL AND METHODS: We reviewed the clinical characteristics, operative reports, and pathologic results of five female patients who underwent radical or simple cystectomy and continent orthotopic urinary diversion. Peri-operative morbidity, postoperative daytime and nighttime continence, renal function, need for protective pads, and self-catheterization were documented. All urodynamic and upper urinary tract imaging studies were reviewed. RESULTS: Follow-up has ranged from 9 to 18 months in these initial patients. Thus far, all five women have achieved acceptable daytime continence, and four of five women have achieved nighttime continence. Only one patient augments volitional voiding with intermittent self catheterization. Complications consisted of urinary retention in one patient and development of a urinary tract and bladder calculus, which necessitated cystolitholapaxy, in another patients. Neobladder capacities have ranged from 400 to 600 mL with voided volumes up to 300 mL. Only one patient has had a substantial residual urine volume (300 mL). All upper urinary tract imaging studies have shown stable function, and urodynamic studies have revealed high-compliance, large-volume neobladder capacities in all patients. CONCLUSION: Bladder replacement pouches designed from detubularized bowel are gaining widespread acceptance among urologists and their patients. Although these operations have previously been limited to men because of concerns about cancer-involved margins and continence after cystectomy in female patients, recent advances in the knowledge of female pelvic anatomy and neurovascular innervation of the bladder neck and proximal urethra have facilitated nerve-preserving radical cystectomy in women that allows continence and volitional voiding through the urethra.

Aged↗
PubMed1998

Current status of transurethral thermotherapy at the Mayo Clinic.

With the ever-expanding elderly population in the United States, benign prostatic hyperplasia (BPH) has become a widespread condition. Although surgical intervention (open prostatectomy and transurethral resection of the prostate) was the typical management approach for BPH in the past, other options currently include drug therapy and transurethral thermotherapy, a minimally invasive procedure that involves the targeting of heat deep within the prostate transition zone while cooling the surrounding anatomic structures with circulating water. Two thermo-therapy-devices--the Prostatron and the T3 transurethral thermoablation therapy catheter--have been studied in randomized controlled clinical trials at the Mayo Clinic. Both devices were shown to be effective in a substantial subset of patients with BPH: symptom scores decreased, peak urinary flow rates increased, and total serum prostate-specific antigen levels increased, an indication of destruction of adenomatous tissue. All patients were able to complete the treatment without the need for general or regional anesthesia, and thermotherapy was associated with few postprocedural events. Although this therapeutic strategy is currently used selectively in patients with lateral lobe prostatic adenoma, improvements in technology and understanding of the thermoregulatory properties of the prostate should broaden the application of thermotherapy devices in the management of BPH.

Adult↗
PubMed1997

Ureteroscopy: current practice and long-term complications.

PURPOSE: We compared a current cohort of patients who underwent ureteroscopy to a cohort from the early 1980s to determine changes in success, indications and long-term complications of the procedure. MATERIALS AND METHODS: A chart review was performed of 194 patients who underwent 209 ureteroscopic procedures at our institution during 1992. This group was then statistically compared to 317 patients who underwent 346 ureteroscopies between 1982 and 1985. RESULTS: The current indications for ureteroscopy were calculus extraction (67% of the cases), diagnosis (28%) and stent manipulation (5%). These indications differed from those of the early series, in which 84% of all ureteroscopies were performed for calculus extraction and 16% for diagnosis. Overall ureteroscopic success rate increased from 86 to 96% (p < 0.001). Success of stone extraction improved from 89 to 95% (p = 0.08, distal success rate 95 to 97% and proximal success rate 72 to 77%). Success of diagnostic inspections increased from 73 to 98% (p < 0.001). In the early series failure was usually due to inability to traverse the ureter (54% of the cases), while currently failure is due almost exclusively to impassable ureteral strictures (63%). The overall complication rate decreased from 20 to 12% (p = 0.01) and the rate of significant complications decreased from 6.6 to 1.5% (p < 0.05). Clinical followup (mean 36 months) for all patients and radiological followup (mean 9.8 months) for 67% of eligible patients detected only 1 ureteral stricture. The remaining patients were asymptomatic after the ureteroscopic procedure. CONCLUSIONS: Improvements in ureteroscope design, accessories and technique have led to a significant increase in the success of diagnostic and therapeutic ureteroscopy while decreasing morbidity. Outpatient ureteroscopic stone extraction, particularly for distal ureteral calculi, is almost uniformly successful with low morbidity. The long-term complication rate of ureteroscopy is 0.5%.

Adolescent↗
PubMed1997

Irradiation for locally recurrent carcinoma of the prostate following radical prostatectomy.

OBJECTIVES: To evaluate the outcome of patients treated with irradiation (RT) for isolated, clinically apparent local tumor recurrence following prostatectomy for carcinoma of the prostate (CaP). METHODS: Between May 1979 and July 1992, 35 patients received external-beam RT as sole salvage therapy for post-prostatectomy locally recurrent CaP. Patient outcome was evaluated through retrospective medical record review with respect to clinical and prostate-specific antigen-based (that is, biochemical) control rates, as well as disease-free (clinical and biochemical) and overall survival estimates. Chronic RT-induced morbidity was also examined, and pre-RT disease characteristics were evaluated for their association with disease outcome. RESULTS: With median follow-up of 5.2 years (range 1.7 to 12.1) in survivors (30 patients), 19 patients (54%) had clinical (local, 1 patient [3%]; metastatic, 7 patients [20%]) or biochemical only (11 patients [31%]) relapse. The 8-year clinical relapse-free and any relapse-free (clinical or biochemical) rates were 80% and 56%, respectively, whereas the overall survival estimate was 97%. A chronic complication(s) of treatment was noted in 15 patients (43%) but spontaneously resolved in all but 6 (17%); persistent complications were mild and associated with rectal (grade 1 to 2, 14%) and lymphatic (3%) systems. The interval between prostatectomy and local tumor recurrence, the pre-RT prostate-specific antigen serum level, the pathologic stage, and tumor differentiation may be associated with disease outcome. CONCLUSIONS: External-beam RT resulted in excellent local tumor control without serious long-term morbidity in most patients. Although this study could not define an optimal management strategy (for example, symptomatic measures only, RT, or hormonal therapy), these results provided outcome measures, in relationship to pre-RT tumor-related factors, that may be valuable for clinical decision-making.

Follow-Up Studies↗
PubMed1997

Anatomic site-specific positive margins in organ-confined prostate cancer and its impact on outcome after radical prostatectomy.

OBJECTIVES: The impact of a positive surgical margin in otherwise confined prostate cancer after radical prostatectomy remains unclear. We analyzed the outcome of a large number of patients with organ-confined prostate cancer according to the presence and anatomic site of margin positivity. METHODS: We evaluated 2712 prostatectomy patients with Stage pT2N0 cancer (ie, no evidence of extra-prostatic disease, seminal vesicle or regional node involvement) and no prior therapy who were treated by radical prostatectomy between 1987 and 1995 at Mayo Clinic. A total of 697 patients (26%) had positive margins. To assess the effect of margin status in the absence of treatment, 378 patients with postoperative adjuvant therapy were not considered for the study group: the final group consisted of 2334 patients. RESULTS: Overall, 253 (58%) tumors were positive at the apex and/or urethra, 85 (19%) at the prostate base, 11 (2.5%) at the anterior prostate, and 174 (40%) at the posterior prostate; 89 (20%) had at least two margins involved and 21 (8.3%) had more than two involved. The apex/urethra was the only positive anatomic site in 183 (42%). Five-year survival free of clinical recurrence or prostate-specific antigen (PSA) biochemical failure (postoperative serum PSA of 0.2 ng/mL or more) for patients with a single positive margin was 79% for apex or urethra, 78% for anterior/posterior, and 56% for prostate base. Five-year survival free of clinical recurrence or PSA (biochemical) failure was slightly higher for those with one versus two margin-positive regions (77% versus 68%, respectively). Multivariate analysis revealed that positive surgical margins were a significant predictor of clinical recurrence and PSA (biochemical) failure (relative risk [95% confidence interval]: 1.65 [1.24, 2.18]) after controlling for Gleason grade, preoperative PSA, and deoxyribonucleic acid (DNA) ploidy. The effect of margin positivity on recurrence at a specific anatomic site (versus negative margins or positive at a different anatomic site) revealed the prostate base to be the only significant anatomic site when adjusted for grade, PSA, and ploidy. Five-year survival free of the combined clinical or PSA failure end point for those with versus those without positive margins at the prostate base was 56% versus 85%, respectively (P < 0.0001). CONCLUSIONS: Positive surgical margins are a significant predictor of recurrence in Stage pT2N0 cancer, which is independent of grade, PSA, and DNA ploidy. The impact of positive margin status on recurrence-free survival appears to be anatomic and site-specific, with prostate base positivity significantly associated with poor outcome. The benefit of adjuvant therapy based on anatomic site-specific margin positivity remains to be tested in order to optimize recurrence-free survival.

Follow-Up Studies↗
PubMed1997

Primary surgical therapy for clinical stage T3 adenocarcinoma of the prostate.

Radical prostatectomy has not been a widely accepted treatment option in patients with clinical stage T3 prostate cancer due to the potential for incomplete excision of tumor and the high incidence of lymph node metastases. In addition, the morbidity of surgical therapy in these patients has been questioned. As a result, alternative treatment modalities, including androgen ablative therapy and radiotherapy, are often used in patients with locally advanced disease. However, in terms of local disease control and long-term disease-free survival rates, most alternative treatments have serious limitations in clinical stage T3 tumors. We recently reported our extended experience with radical prostatectomy and adjuvant therapy in a large group of patients with clinical stage T3 disease and this article updates that experience. Although 31% of patients in our series had node-positive disease, 25% had pathologically organ-confined tumors likely to be cured by surgical therapy alone. Cancer-specific survival rates at 5, 10, and 15 years were 93%, 84%, and 74%, respectively, and operative morbidity paralleled that of patients with clinically localized disease. Our experience suggests that excellent long-term survival with low treatment-related morbidity can be achieved with radical prostatectomy and adjuvant therapy in patients with clinical stage T3 prostate cancer.

Adenocarcinoma↗
PubMed1997

Preoperative androgen-deprivation therapy for clinical stage T3 prostate cancer.

The widespread availability of luteinizing hormone-releasing hormone analogues has renewed interest in androgen-deprivation therapy (ADT) before radical prostatectomy. Neoadjuvant ADT in patients with clinically localized tumors has resulted in decreased margin-positive rates and increased rates of organ-confined disease. Unfortunately, the pathological effects of ADT in patients with locally advanced (cT3) prostate cancer have been less marked. This article reviews our experience with neoadjuvant hormonal therapy in patients with clinical stage T3 prostate cancer. In a case-control study of cT3 patients undergoing radical retropubic prostatectomy between 1985 and 1992, 72 patients receiving preoperative ADT were compared with a matched group of 144 untreated patients in terms of pathological outcome and long-term disease-free survival. A local downstaging effect in hormonally treated patients was suggested by lower rates of extracapsular extension, but only 31% had organ-confined disease. Hormonally treated patients showed no benefit in survival or disease progression compared with patients who did not receive this therapy. Although preoperative ADT may decrease the incidence of extracapsular extension in clinical stage T3 prostate cancer, our data suggest that it has no significant effect on survival or disease progression in patients with locally advanced disease.

Aged↗
PubMed1996

Correlation of pretherapy prostate cancer characteristics with seminal vesicle invasion in radical prostatectomy specimens.

PURPOSE: This study was conducted to identify pretherapy factors associated with seminal vesicle invasion (SVI) in patients with localized carcinoma of the prostate (CaP), and to develop a model that would allow estimation of the likelihood for SVI at the time of initial diagnosis. METHODS AND MATERIALS: Between January 1988 and December 1993, 2959 patients underwent radical retropubic prostatectomy, with or without pelvic lymph node dissection, as initial therapy for clinical Stage T1a-3bN0-XM0 CaP. Preoperative patient and tumor-related characteristics were evaluated for an association with SVI in univariate and multivariate logistic regression analyses. A model was developed and probability plots were constructed to display the estimated likelihood for SVI in the patients with a new diagnosis of localized CaP. RESULTS: Within clinical tumor stage, three groups (T1a-2a, T2b-c, and T3a-b) were observed to have a distinctly different rate of SVI. Gleason primary grades were combined (1-2, 3 and 4-5) because of a similar observation. Univariate analysis identified clinical tumor stage (p < 0.0001), Gleason primary grade (p < 0.0001), and serum prostate-specific antigen level (p < 0.0001) as factors associated with the likelihood for SVI. Multivariate analysis confirmed the independent significance (p = 0.0001) of each of these factors. Patient age (p = 0.16) and history of prior transurethral resection of the prostate (p = 0.82) were not associated with this end point. Probability plots were constructed to display the likelihood of SVI as a function of pretherapy clinical tumor stage, Gleason primary grade, and serum prostate-specific antigen value. CONCLUSION: In the patient with a new diagnosis of localized CaP, clinical tumor stage as determined by digital rectal examination, diagnostic biopsy tumor (Gleason primary) grade, and pretherapy serum prostate-specific antigen value were significant factors for development of a model that estimated the likelihood of SVI. Estimates from this type of model may be of value in the pretherapy diagnostic evaluation of such patients, and may aid in the administration of radiation therapy.

Adult↗
PubMed1996

Long-term follow-up of endoscopically treated upper urinary tract transitional cell carcinoma.

OBJECTIVES: This report focuses on the long-term follow-up of patients with endoscopically treated upper tract transitional cell carcinoma (TCC) to determine the effectiveness of endoscopic therapy. METHODS: From May 1983 to April 1994, 44 patients with TCC of the upper urinary tract underwent conservative endourologic treatment with either electrocautery fulguration or neodymium:yttrium-aluminum-garnet laser at our institution. The mean follow-up period was 5 years (range, 3 months to 11 years). RESULTS: Renal pelvic tumor sizes ranged from 0.4 to 4.0 cm (mean, 1.5) and ureteral tumors from 0.2 to 1.0 cm (mean, 0.5). The majority of tumors were of pathologic grade 3 or less, and all were Stage T2 or less. Seventeen of 44 patients (38.6%) had local tumor recurrence (mean time to recurrence, 12.8 months; range 1.5 to 64). Mean recurrence time was 7.3 months for renal pelvic tumors and 17.8 months for ureteral tumors. Nineteen of 44 patients (43.2%) developed bladder tumors. The overall 5-year disease-free rate was 57%. No recurrent tumor was shown to have increased in grade, and one recurrent tumor was proved to have progressed in stage. Six patients (14%) ultimately required a nephroureterectomy for recurrence. There were no major complications as a result of endoscopic therapy. Six patients (14%) died of the effects of metastatic TCC, 5 of whom had known muscle invasive bladder TCC. CONCLUSIONS: Endourologic techniques and the conservative treatment of upper urinary tract TCC is an evolving field and can be safely and effectively used as a first-line treatment for upper tract TCC in selected patients.

Aged↗
PubMed1996

Free, complexed, and total serum prostate-specific antigen concentrations and their proportions in predicting stage, grade, and deoxyribonucleic acid ploidy in patients with adenocarcinoma of the prostate.

OBJECTIVES: Nearly half of men with clinically localized prostate cancer are understaged. We evaluated whether knowledge of preoperative free prostate-specific antigen (f-PSA), complexed (c-PSA), and total (t-PSA) concentrations or the ratios thereof (f-PSA/t-PSA, c-PSA/t-PSA, and f-PSA/c-PSA) could improve upon the staging of prostate cancer when compared with standard PSA testing (t-PSA). In addition, we examined their associations with tumor grade and deoxyribonucleic acid (DNA) ploidy. METHODS: Two hundred ninety patients with prostate cancer, 178 (61%) of whom were treated with radical prostatectomy, formed the study group. RESULTS: Although there were significant differences in the f-PSA concentrations with respect to clinical stage, considerable overlap in PSA levels among the clinical substages was observed. Statistically significant differences but weak correlations were observed between the individual f-PSA, c-PSA, and t-PSA concentrations with regard to pathologic stage (organ-confined versus extraprostatic) and grade. No significant relationship, however, was observed with the three ratios. Higher PSA values were not always associated with a pathologic stage of pT3 or greater, and lower levels did not ensure that a tumor was organ-confined. Only a slight association was observed between c-PSA and t-PSA levels and DNA ploidy. No significant relationship was observed between the f-PSA levels as well as the three ratios with regard to DNA ploidy. A statistically significant improvement in predicting pathologic stage was observed when combining knowledge of preoperative t-PSA concentration with the c-PSA/t-PSA ratio. However, the area under the receiver operator characteristic curves was only slightly increased; as such this combination was of limited clinical utility. CONCLUSIONS: Statistically significant but weak correlations were observed between the molecular forms of PSA and stage, grade, and DNA ploidy. The significant overlap in f-PSA and c-PSA values among all stages, grades, and ploidy values precluded any useful predictive information for the individual patient. As such, preoperative knowledge of f-PSA and c-PSA values and the three ratios provided no additional diagnostic information over standard PSA (t-PSA) values alone.

Adenocarcinoma↗
PubMed1996

Transurethral microwave thermotherapy v sham treatment: double-blind randomized study.

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.

Aged↗