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PubMed2005

A double-blind placebo-controlled study evaluating the onset of action of doxazosin gastrointestinal therapeutic system in the treatment of benign prostatic hyperplasia.

OBJECTIVE: To determine the onset of improvement in benign prostatic hyperplasia symptoms in patients after treatment with doxazosin gastrointestinal therapeutic system (DOX GITS) versus placebo. METHODS: In this prospective, randomized, double-blind, placebo-controlled trial, baseline values, including International Prostate Symptom Score (IPSS) and maximum urine flow rate (Q(max)), were determined following a 2-week placebo run-in. Patients received DOX GITS 4 mg/d (n = 108) or placebo (n = 105) for 14 days. IPSS was measured on Days 3, 7, and 14; Q(max) on Days 1, 3, 7, and 14; and the patients' perception of improvement was measured on Days 1 and 2 in the evening at home and in the office on Day 14. RESULTS: Significantly more patients treated with DOX GITS than placebo perceived improvement after Day 1 (60.6% vs. 41.9%) through Day 14 (84.3% vs. 64.1%). On Day 1, improvement in Q(max) with DOX GITS was not significantly different compared with placebo. On Day 3 of the trial (1) IPSS improvement was significantly greater with DOX GITS than with placebo; (2) proportion of patients with > or =30% improvement in IPSS was significantly greater with DOX GITS (49.5%) than placebo (28.4%) and remained so through Day 14; (3) improvement in Q(max) was significantly greater with DOX GITS (3.7 mL/s) than placebo (1.9 mL/s) and remained so through Day 14; (4) proportion of patients with > or =3 mL/s increase in Q(max) was statistically greater with DOX GITS (54.4%) versus placebo (30.8%) and remained so through Day 14. CONCLUSIONS: DOX GITS significantly improved IPSS and Q(max) by Day 3 of treatment, and these changes were maintained through Day 14. More patients receiving DOX GITS than placebo perceived improvement in symptoms as early as Day 1.

Adrenergic alpha-Antagonists↗

PubMed1990

Complications in hyperthermia treatment of benign prostatic hyperplasia.

Of 435 patients treated with local hyperthermia to the prostate 27 had 29 complications, for an over-all complication rate of 6.6%. Urinary tract infections (7 cases), hematuria (6), and epididymitis (2) accounted for roughly half of the complications and could be attributed to the insertion of a catheter rather than the treatment itself but this remains to be proved. Most of the complications occurred within the first 3 treatment sessions. Despite the complication, 9 patients continued and completed the treatment course. Mean age of the study group was 73 +/- 8.3 years. Given the age of these patients, high incidence of accompanying diseases and low rate of complications, local hyperthermia should be considered a viable low risk treatment option in patients with benign prostatic hyperplasia.

Aged↗

PubMed1982

Studies on carcinogenesis of human prostate. II. Long-term explant culture of normal prostate and benign prostatic hyperplasia: light microscopy.

Light microscopic and histochemical changes in normal human prostate and benign prostatic hyperplasia (BPH) during long-term explant culture were characterized. Normal human prostate obtained at immediate autopsy of young adults or BPH obtained at the time of surgery were maintained in explant culture as long as 24 weeks. Morphologic alterations in glandular epithelium and stroma in response to culture conditions were assessed by light microscopy and histochemistry of mucosubstances. The histologic and histochemical responses of normal prostate and BPH to in vitro conditions were essentially identical. Within 1 week, secretory epithelial cells became necrotic and sloughed into acinar lumina. Remaining epithelial cells proliferated, repopulated acinar structures, and migrated onto explant surfaces forming a new well-differentiated epithelium characterized by synthesis and secretion of neutral and acidic mucosubstances. During subsequent periods in vitro, synthesis and secretion of mucosubstances gradually diminished whereas the stroma and deep glandular structures became necrotic. Our observations suggest that cells comprising the new epithelium in cultured explants of normal human prostate and BPH are derived from prostatic basal cells.

Adolescent↗

PubMed1997

Changes in keratin expression during the development of benign prostatic hyperplasia.

OBJECTIVE: The relationship between different types of epithelial cells in the prostate and the regulatory mechanism underlying benign prostatic hyperplasia (BPH) are still obscure as is the association between BPH and prostate carcinoma (PCa.) On the basis of keratin immunophenotyping, a subpopulation of cells in normal rat prostate and human PCa have been identified as candidates for the 'amplifying cell' in the stem cell model. In this model the basal cell is described as being associated with the stem cell. From this precursor an intermediate cell type develops which may differentiate into the luminal-type cell. In this study these different cell types are investigated in the development of isolated BPH and BPH associated with PCa, using monoclonal antibodies to intermediate filaments of the keratin class. METHODS: We immunohistochemically stained 64 snap-frozen human prostatic tissues, using monoclonal antibodies against keratin 14 (marker for putative 'stem cell'), keratin 18 (marker for putative 'transit cell'), and MAb RCK103 (marker for putative 'amplifying cell' or intermediate cell). RESULTS: In basal cell hyperplasia, an atypical form of BPH, keratins previously associated with intermediate cells were frequently detected. Cells with this keratin phenotype were detected in the luminal compartment of BPH, and were more prevalent in BPH adjacent to PCa. This keratin expression pattern was similar to that of PCa. CONCLUSION: On the basis of keratin phenotyping we demonstrated that large numbers of cells with the keratin expression pattern of so-called intermediate cells were identified in BPH associated with PCa, while in isolated BPH these cells were infrequently found. This supports the concept that BPH with intermediate phenotype may have premalignant potential. Furthermore this is suggestive of an etiologic relationship between the two diseases.

Antibodies, Monoclonal↗

PubMed2003

Detection of prostate cancer and changes in prostate-specific antigen (PSA) six months after surgery for benign prostatic hyperplasia in patients with elevated PSA.

OBJECTIVE: To evaluate early postoperative results of patients with elevated prostate-specific antigen (PSA) levels who underwent surgery due to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: 64 patients who had lower urinary tract symptoms (LUTS), normal digital rectal examinations (DRE), elevated PSA levels and prostate biopsies reported as being benign pathologically in specimens obtained by transrectal ultrasound (TRUS)-guided biopsies, were included in the study. Patients were assessed in accordance with PSA density, free/total PSA ratio and uroflowmetric studies. Patients had no cancer pre- and postoperatively (according to operative specimens). Six months postoperatively, 32 patients were accepted for re-evaluation for all PSA parameters, routine tests and prostatic biopsies. RESULTS: 64 patients with a mean age of 66.8 (SD 6.72) were included in the study. Total PSA average value was 14.38 (SD 7.49) ng/ml. Free PSA average value was 2.11 (SD 1.43) ng/ml. Average PSA density and free/total PSA ratio were 25.19 SD (14.12) ng/ml/cm(3) and 14.53% (SD 5.35%) respectively. 56 patients had BPH, 7 had chronic prostatitis and 1 had prostatic intraepithelial neoplasia (PIN) preoperatively with biopsies. Re-biopsy of the patient with PIN was reported as BPH. In pathologic examination with resected tissues postoperatively, 49 patients had BPH, 14 had chronic prostatitis and 1 had PIN. In the sixth month, average values of free/total PSA were 0.45 (SD 0.26) and 3.71 (SD 4.96) ng/ml respectively. Average PSA density and free/total PSA ratio were 12.41 (SD 13.8) ng/ml/cm(3) and 19.59% (SD 10.33%) respectively. There were significant decreases in PSA densities (p < 0.001) and increases in free/total PSA ratios (p = 0.004). Seven patients still had elevated PSA levels 6 months postoperatively. Three of 7 patients were reported as chronic prostatitis. One of them was indicated as prostatic carcinoma who was reported as PIN preoperatively. All other patients were stated as BPH at re-biopsies. CONCLUSION: If pretreatment biopsies are negative and operative specimens are also benign in patients with high PSA values, these patients can be followed up like usual BPH patients, but long-term follow-up is still unclear.

Aged↗

PubMed1993

Transurethral needle ablation (TUNA): thermal gradient mapping and comparison of lesion size in a tissue model and in patients with benign prostatic hyperplasia.

A new device has been development for treating benign prostatic hyperplasia (BPH) that is performed as an outpatient procedure. the device (transurethral needle ablation or TUNA) employs needles that deliver low-level radiofrequency (RF) power locally at high temperature to ablate hyperplastic prostate tissue. During the TUNA procedure the temperature proximal to the needle tips is measured with thermocouples within the needle's protective shields and urethral temperature is measured via a thermocouple contained within the catheter tip. Tissue impedance is also measured by the TUNA catheter since it is well known from other thermal treatment methods that thermal destruction of prostatic tissue depends upon a particular prostate's tissue composition and thermoregulation. Because of this variation in prostates, a nomogram guide for setting the TUNA device was created using a turkey breast tissue model. Lesion sizes created at particular settings in the turkey breast model were similar to those created at the same settings in patients with BPH. In addition, local thermal gradients within the TUNA lesions were visualized and mapped using an infrared thermal imaging system which demonstrated that central lesion temperature with the device is approximately 80-100 degrees C.

Catheter Ablation↗

PubMed1996

Effect of obesity on prostatic hyperplasia: its relation to sex steroid levels.

In 68 men with benign prostatic hyperplasia, we evaluated the association between obesity and prostatic enlargement, as well as changes in serum levels of oestradiol, testosterone, dihydroepiandrosterone and dihydroepiandrosterone sulphate. Despite the larger adenomas, no increase in the symptom score for BPH was observed with increasing obesity. Average specimen weights increased with increasingly obesity and increasing host age from 46 to 80 g. We also found the serum oestradiol level significantly elevated in obese men who were 140% or over recommended weight compared to underweight men younger than 60 years (51.3 pg/ml versus 26.8 pg/ml, p < 0.01). This pattern was present in all age groups. These results indicate that obesity is a risk factor for prostatic enlargement but not for obstruction. Also the degree of obesity appears to have a direct effect on oestradiol levels through transformation of androgens in adipose tissue to oestrogens. In conclusion, further studies to evaluate the pathogenesis, pathophysiology, natural history and symptomatology of BPH would be of great interest and should help to define better the associations that we have recognized.

Aged↗

PubMed2001

Hyperinsulinaemia as a risk factor for developing benign prostatic hyperplasia.

OBJECTIVE: To determine the validity coefficient of the total prostate gland volume as an expression of the transition zone (TZ) volume. To test the hypothesis of hyperinsulinaemia as a causal factor for the development of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Three hundred and seven consecutive patients with lower urinary tract symptoms were studied. A subgroup of 114 patients were tested with regard to the validity coefficient between the total prostate gland volume and the TZ volume. In the total material of 307 men, a BPH risk factor analysis was performed in which groups of men with the following conditions were related to the annual BPH growth rate: men without or with metabolic disease; men with different components of the metabolic syndrome, and men with low or high fasting plasma insulin values. The prostate gland volume and the TZ volume were determined using ultrasound. The presence of non-insulin-dependent diabetes mellitus (NIDDM) and treated hypertension was obtained from the patients' medical records. Data on blood pressure, waist and hip measurement, body height and weight were collected and body mass index and waist/hip ratio were calculated. Blood samples were drawn from fasting patients to determine the insulin and HDL-cholesterol values. RESULTS: In the subgroup of men subjected to measurement of both the total prostate gland volume and the TZ volume, the correlation coefficient between total prostate gland volume and the TZ volume was r.s. = 0.97 (p < 0.0001) which, thus, constituted the validity coefficient. The median annual BPH growth rate in the total group was 1.03 ml/year. The median annual BPH growth rate was faster in men with metabolic disease (p < 0.0001), NIDDM (p < 0.0001), treated hypertension (p < 0.0001), obesity (p < 0.0001) and dyslipidaemia (p < 0.0001) than in men without metabolic disease. Moreover, the annual BPH growth rate correlated positively with the diastolic blood pressure (r.s. = 0.27; p < 0.001), the BMI (r.s. = 0.22; p < 0.001) and four other expressions of obesity, and negatively with the HDL-cholesterol level (r.s. = -0.15; p < 0.001). The median annual BPH growth rate was faster in men with a high than in men with a low fasting plasma insulin level (p = 0.019). When the patients were divided into quartiles, the median annual BPH growth rate increased statistically significantly with increasing fasting plasma insulin levels. The fasting plasma insulin values correlated with the annual BPH growth rates (p = 0.009). When performing a multivariate analysis using the total prostate gland volume as dependent variable, fasting plasma insulin (p = 0.001) and age (p < 0.001) became statistically significant. CONCLUSION: The results of the present report suggest that the total prostate gland volume constitutes a valid expression of BPH. The findings support the hypothesis that hyperinsulinaemia is causally related to the development of BPH and generate the hypothesis of an increased sympathetic nerve activity in men with BPH.

Aged↗

PubMed2005

Treatment of benign prostatic hyperplasia using transurethral microwave thermotherapy and dilatation with double-balloon catheter.

PURPOSE: To improve the outcome of transurethral microwave thermotherapy (TUMT) for the treatment of benign prostatic hyperplasia, we combined TUMT and balloon dilatation (BD) with a double-balloon catheter and investigated its effects. PATIENTS AND METHODS: For a short-term trial, 40 patients were divided randomly into two groups: 20 patients received TUMT alone, and the other 20 received TUMT followed by BD. The degrees of symptoms were graded according to the International Prostate Symptom Score and Quality of Life score, and the peak urinary flow rate was measured before and 10 weeks after treatment. A historic control study of 527 patients was also performed to evaluate the long-term re-treatment rate: 98 of the patients received TUMT alone, and the other 429 patients received TUMT followed by BD. RESULTS: The symptom scores improved significantly in both groups. The peak uroflow rate was significantly increased in the group who received TUMT followed by BD (P < 0.01), whereas the change was not significant in the TUMT-alone group. Significant sustainability of long-term effects was more evident in patients receiving TUMT plus BD than in the TUMT-alone group, as judged by the higher proportion of BD-treated patients who required no further treatment during the 5-year study period in comparison with patients who received TUMT alone (66.3% v 28.6%, respectively; P < 0.001). CONCLUSIONS: Combined TUMT and BD achieves sufficient subjective and objective improvement and a sustainable long-term effect. We consider this combination technique to be useful for the treatment of prostatic hyperplasia.

Aged↗

PubMed2001

Targeted transurethral microwave thermotherapy versus alpha-blockade in benign prostatic hyperplasia: outcomes at 18 months.

OBJECTIVES: To compare directly the efficacy, safety, and durability of targeted transurethral microwave thermotherapy with that of alpha-blocker treatment for lower urinary tract symptoms of benign prostatic hyperplasia. METHODS: In a randomized, controlled clinical trial, 52 patients with lower urinary tract symptoms due to benign prostatic hyperplasia received terazosin treatment and 51 underwent microwave treatment under topical anesthesia. The patient evaluation included the International Prostate Symptom Score, peak flow rate, and quality-of-life score before microwave treatment or initiation of terazosin treatment and at periodic intervals thereafter up to 18 months. RESULTS: The mean International Prostate Symptom Score, peak flow rate, and quality-of-life score all improved significantly in both groups by 6 months. However, the magnitude of improvement was significantly greater in the microwave group than in the terazosin group. The significant between-group differences observed at 6 months in the mean International Prostate Symptom Score, peak flow rate, and quality-of-life score were fully maintained at 18 months, at which time the improvements in these three outcome measures were significantly greater (P <0.0005), by 35%, 22%, and 43%, respectively, in the microwave group than in the terazosin group. The actuarial rate of treatment failure at 18 months was significantly greater by sevenfold in the terazosin group. Adverse events were generally infrequent and readily manageable in both groups. CONCLUSIONS: Although the initial onset of terazosin action was more rapid, the longer term clinical outcomes of targeted microwave treatment were markedly superior. The more favorable results in patients who underwent microwave treatment were maintained for at least 18 months.

Adrenergic alpha-Antagonists↗

PubMed2004

Effects of transurethral resection of prostate on the quality of life of patients with benign prostatic hyperplasia.

BACKGROUND: This article investigated the effects of transurethral resection of prostate on quality of life (QOL) and urinary symptoms in patients with benign prostatic hyperplasia (BPH). STUDY DESIGN: In a prospective study, 30 patients without significant comorbidities undergoing transurethral resection of prostate for BPH were studied. Patients completed four validated questionnaires: the International Prostate Symptom Score and the associated QOL index because urinary symptoms, the Montgomery and Asberg Depression Rating Scale, the McGill Pain Questionnaire, and the QOL questionnaire Short Form-36. These were completed preoperatively, on the first postoperative day, on discharge from hospital, and at 1 and 3 months postoperatively. RESULTS: The QOL of patients who undergo transurethral resection of prostate for BPH had significantly improved at 3 months after their operation. The International Prostate Symptom Score scores at 1 month (9.3+/-4.6) and 3 months (5.4+/-5.6) were less than they were preoperatively (19.9+/-7.1). The QOL index because urinary symptoms was less at 1 month (2.4+/-1.9) and at 3 months postoperatively (1.5+/-1.4) in comparison with the preoperative scores (4.5+/-1.2). The Montgomery and Asberg Depression Rating Scale scores at 1 month (5.4+/-6.8) and 3 months (4.9+/-6.5) were less than they were preoperatively (9.2+/-8.3). The McGill Pain Questionnaire sensory and pain rating index scores were less at 3 months than they were preoperatively (p=0.02 and p<0.02 respectively). The McGill Pain Questionnaire affective score was less at 1 month than it was preoperatively (p<0.03). The McGill Pain Questionnaire evaluative scores were less than the preoperative score at all times postoperatively. The role physical (p=0.007), bodily pain (p=0.006), social function (p=0.007), and physical component summary (p=0.007) subsections of the Short Form-36 were greater at 3 months postoperatively when compared with the preoperative scores. CONCLUSIONS: Transurethral resection of prostate is associated with significant improvement in the overall QOL, in addition to urinary symptoms, of patients with BPH at 3 months postoperatively. The magnitude and timing of this improvement may serve as a useful comparator in determining the optimal treatment of patients with BPH.

Aged↗

PubMedDate not supplied

Heating characteristics of a helical microwave applicator for transurethral hyperthermia of benign prostatic hyperplasia.

A new applicator for intraurethral hyperthermic treatment of benign prostatic hyperplasia is described. The applicator uses an insulated helical antenna wound on the outer surface of a silicone urological (Foley) balloon catheter. The balloon catheter assures rapid and reproducible localization of the antenna in the prostatic urethra. Two small cannulae are fixed to the exterior surface of the applicator. One holds a temperature control sensor at a fixed location, the other is used to map temperature along the applicator. Two-dimensional SAR and steady-state temperature distributions measured in a plane tangent to the applicator in a tissue-equivalent phantom are presented, as well as longitudinal temperature distributions measured in situ at the applicator-urethral interface. Prostatic temperatures were also measured intraoperatively. The applicator appears to be capable of elevating temperature to greater than 42 degrees C in a cylindrically symmetric volume of about 4 cm length and about 0.5 cm radial penetration surrounding the antenna. The heating characteristics of this applicator are similar to an earlier design that employed an array of three dipoles. The helical applicator is narrower, more flexible and simpler to use than the earlier design.

Biomedical Engineering↗

PubMed1995

Transition zone index as a method of assessing benign prostatic hyperplasia: correlation with symptoms, urine flow and detrusor pressure.

PURPOSE: Prostate volume has been poorly correlated to various parameters used to assess benign prostatic hyperplasia (BPH), including symptoms, peak urine flow and detrusor pressure at peak urine flow. The purpose of this study was 2-fold: 1) to determine if transrectal ultrasound measurement of the transition zone of the prostate served as a better proxy for determining prostate size and correlated better with American Urological Association symptom score, peak urine flow and detrusor pressure, and 2) if the parameter transition zone index (the ratio between transition zone volume and prostate volume) was useful in evaluating clinical prostatism. MATERIALS AND METHODS: We prospectively evaluated 61 men with symptomatic BPH (age 64.6 +/- 9.7 years) according to symptoms, peak urine flow, pressure/flow analysis, transrectal ultrasound volume of the entire prostate and the transition zone, and calculation of the transition zone index. RESULTS: Age correlated with symptoms (r = 0.31, p = 0.01) and peak urine flow correlated negatively with symptoms and age (p = 0.002). Age also correlated with prostate volume (r = 0.54 and p = 0.03) and transition zone (r = 0.31, p = 0.05). There was a weak correlation between prostate volume and symptoms, peak urine flow and detrusor pressure at peak urine flow; a stronger correlation between transition zone and symptoms (r = 0.48, p = 0.03), and peak urine flow (r = -0.34, p = 0.05), and a significant correlation (p = 0.001) between transition zone index and symptoms (r = 0.75), peak urine flow (r = -0.71) and detrusor pressure at peak urine flow (r = 0.43). A transition zone index of greater than 0.50 was a useful cutoff point and highly significant (p = 0.002) for delineating patients with more severe abnormalities of symptoms, peak urine flow and detrusor pressure at peak urine flow. CONCLUSIONS: Transition zone index is a parameter that correlates significantly with evaluated parameters of BPH and may serve as a useful proxy for evaluating worsening obstruction. Studies are underway to determine if transition zone index can be used prospectively to predict and correlate response with therapies designed to ablate prostatic tissue medically or surgically.

Age Distribution↗

PubMed2002

[Clinical evaluation of the effect of tamsulosin hydrochloride and cernitin pollen extract on urinary disturbance associated with benign prostatic hyperplasia in a multicentered study].

We evaluated the clinical efficacy and safety of tamsulosin hydrochloride and cernitin pollen extract in 243 patients with urinary disturbance associated with benign prostatic hyperplasia. They were assigned randomly to 3 groups, oral tamsulosin hydrochloride, cernitin pollen extract and their combination were administered for 12 weeks. The international prostate symptom score, post-voided residual urine and uroflowmetrogram were obtained before and after treatment. The international prostate symptom score improved in each group and then the maximum flow rate and average flow rate also increased significantly in the tamsulosin hydrochloride-administered groups. In conclusion, the administration of only tamsulosin hydrochloride and the combination of tamsulosin hydrochloride and cernitin pollen extract seemed more effective then the administration of only cernitin pollen extract in the treatment of urinary disturbance associated with benign prostatic hyperplasia.

Adrenergic alpha-Antagonists↗

PubMed1982

Studies on carcinogenesis of human prostate. III. Long-term explant culture of normal prostate and benign prostatic hyperplasia: transmission and scanning electron microscopy.

Ultrastructural changes in normal human prostate and benign prostatic hyperplasia (BPH) during long-term explant culture were compared. Explants of normal prostate obtained at immediate autopsy of young adults of BPH obtained at the time of surgery were maintained as long as 24 weeks in vitro. Ultrastructural changes occurring in epithelial cells during culture were monitored by transmission and scanning electron microscopy. Essentially identical results were found for normal prostate and BPH. During the first week of culture, secretory epithelial cells degenerated and sloughed into the acinar lumen, resulting in an accumulation of necrotic debris. During this period, however, epithelial cells with ultrastructural characteristics of basal cells remained viable, repopulated glandular structures, migrated from glands and ducts, and epithelialized adjacent cut surfaces, eventually covering the explant. On explant surfaces, these basal cells initially were squamous-like, but they later became typically cuboidal, polygonal, or sometimes columnar and formed an epithelium, two cells or more thick. Epithelium with similar features lined acini within explants. Epithelial cells at the surface or within explants were distinguished by the presence of microvilli, junctional complexes, multiple Golgi complexes, well-developed rough endoplasmic reticulum, polyribosomes, nuclei with prominent nucleoli, orthodox mitochondria, scattered tonofilaments, and a basal lamina. Some epithelial cells extended from the lumen to the basal lamina; others were oriented along the basal lamina and did not extend to the lumen. By 1--2 weeks in vitro, these epithelial cells began synthesis of mucus-like material. At later intervals of culture, microvilli were shortened and mucosubstances were reduced. During culture, the stroma became progressively hypocellular and necrotic. In summary, explant-cultured epithelial cells of normal human prostate or BPH were similar ultrastructurally and were found to originate from basal cells, which alone survive culture conditions.

Adolescent↗

PubMed1995

[Transurethral laser therapy of benign prostatic hyperplasia].

During the last 4 years, transurethral laser therapy for benign prostatic hyperplasia (BPH) has become an increasingly popular alternative to transurethral resection of the prostate (TURP) for the treatment of obstructive BPH symptoms. Clinical data so far published prove the efficacy of this new therapeutic modality, although the results are up to now possibly inferior to those achieved with TURP. On the other hand, the incidence of severe perioperative complications is significantly lower in patients treated with laser prostatectomy than in those undergoing TURP. Therefore, laser prostatectomy is a reasonable adjunct to the therapeutic spectrum for BPH in high-risk patients. Nevertheless, its role in the treatment of obstructive BPH in low-risk patients cannot be defined until long-term follow-up data are available.

Contraindications↗

PubMed2001

Long-term use of tamsulosin to treat lower urinary tract symptoms/benign prostatic hyperplasia.

PURPOSE: The long-term efficacy and safety of 0.4 mg. tamsulosin once daily were assessed in patients with lower urinary tract symptoms/benign prostatic hyperplasia treated for up to 4 years. MATERIALS AND METHODS: A total of 516 patients were enrolled from 2 European open label studies that were extensions of 3 double-blind controlled studies. RESULTS: Significant improvement in maximum urine flow and total Boyarsky symptom score during the controlled trials was sustained throughout the extension study for up to 4 years in patients who remained on therapy. The increase in mean maximum urine flow from baseline was 1.2 to 2.2 ml. per second (p <0.001) and it remained 11.5 to 12 ml. per second during followup. Total Boyarsky symptom score was decreased from baseline by 4.1 to 4.7 points (p <0.001). The incidence of treatment responders, defined as a 25% or greater decrease in total symptom score, remained stable throughout the 4-year period. Increasing the dose of tamsulosin from 0.4 to 0.8 mg. seemed to have no substantial additional benefit. During the 4 years of treatment 26% of patients had side effects that were considered possibly or probably drug related. However, only 5% of patients discontinued treatment because of drug related side effects. No clinically significant changes in blood pressure or pulse rate occurred during the study. CONCLUSIONS: Long-term treatment with tamsulosin is safe and well tolerated in patients with lower urinary tract symptoms/benign prostatic hyperplasia. Improved efficacy was sustained during 4 years of followup.

Adrenergic alpha-1 Receptor Antagonists↗

PubMed2001

Apoptotic regression of prostatic tissue induced by short-term doxazosin treatment in benign prostatic hyperplasia.

OBJECTIVES: Benign enlargement of the prostate comprises both hypertrophy and in particular hyperplasia of prostatic stromal and glandular compartments. Alpha adrenergic blockade has been shown to be effective in the management of BPH. Recent investigations have shown that this effect may in part be due to apoptosis. METHODS: A total of 29 patients who were symptomatic due to BPH were enrolled into this prospective placebo controlled, double-blind randomized study and underwent prostatectomy at the end of the 4th week. Clinical efficacy was evaluated by a set of detailed investigations. Surgical specimens were analyzed by immunohistochemistry and tissue components of stroma, smooth muscle and glandular epithelium were calculated by a software on a computer after representative areas were scanned and captured as high resolution images. Apoptosis in each tissue specimen was analyzed by Terminal Deoxynucleotidyl Transferase End Labelling (TUNEL) method utilizing Biotin-16-dUTP. RESULTS: Both groups were similar in terms of baseline evaluation in all aspects. There was a steady decline in patients' urinary complaints as evidenced by International Prostate Symptom Score System (IPSS) in the doxazosin group compared to placebo. Uroflowmetric investigations on patients revealed that maximum flow rates in the active drug group increased throughout the study. Mean PSA levels decreased by 14% at the end of the study in the doxazosin group, while it increased by 11% in the placebo group. Average stroma to epithelial ratio in the doxazosin group was 2:1 in comparison to a value of 1:1 in the placebo group. The rate of apoptosis was 2.2% and 3.2% for the epithelial and stromal compartments, respectively, in the doxazosin group, and 1.2% and 2.7% for the placebo arm. CONCLUSIONS: These data suggest apoptosis as the possible underlying molecular mechanism partly responsible for the clinical efficacy and morphological changes induced by doxazosin treatment in BPH.

Adrenergic alpha-Antagonists↗