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[The validity of the IPSS questionnaire in a sample of 262 patients with benign prostatic hyperplasia].

OBJECTIVE: The IPSS is a well-known method for symptom evaluation in patients with prostate disease. The present study analyzes the validity of this self-administered questionnaire in a group of patients from an industrial area in Spain. METHODS: 513 questionnaires (test 1) were sent out to patients with benign prostatic hyperplasia (BPH) who had undergone TUR or adenomectomy. After an interval of 30-60 days, the same questionnaire (test 2) was sent out to all those patients who had correctly answered test 1. The feasibility and reliability of this test in our hands, as well as its ability to discriminate, were determined. Moreover, the relationship between symptoms (S) and quality of life (L) was analyzed. RESULTS: Patient ages ranged from 50 to 86 years (mean 67.6). A) Feasibility (percentage of patients who answered the questionnaire correctly) was 71%. B) Reliability: internal consistency (Cronbach's alpha) was 0.74 and the retest reliability (correlation between the scores of tests 1 and 2) was 0.76 (Pearson's r) and 0.5 (Kendall's T). C) Correlation between symptoms (S) and quality of life (L) was 0.53 (Pearson) and 0.33 (Kendall). D) Discriminating validity (ability of the test alone to diagnose patients with BPH correctly). The patients in the study were compared with a group of 420 "healthy" males from a prostate cancer screening program; the area below the ROC curve was 0.98 (scantily evaluable: healthy patients vs surgical BPH cases). CONCLUSIONS: In our setting, the self-administered IPSS questionnaire had a moderate feasibility (29% of the patients were unable to understand the questionnaire). Our results, in terms of internal consistency and retest reliability, are similar to those of other validation studies conducted in our country (and appreciably worse than those of the original validation studies in the English language). Nevertheless, some items of the questionnaire have an unacceptable retest reliability, particularly those relating to frequency or urgency. Finally, the total symptom (S) score showed a scanty correlation with quality of life (L). We can conclude that although the IPSS questionnaire is a useful method in the assessment of patients with prostate disease, its reliability remains far from optimal.

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[A case-control study on the risk factors of benign prostatic hyperplasia in the suburb of Shenyang].

OBJECTIVE: To investigate the relation between various risk factors and benign prostatic hyperplasia (BPH). METHODS: A population based case-control study was conducted, including 100 BPH patients over 60 years old living in suburb of Shenyang as study group, and 100 elderly men with non-BPH (excluding prostatic cancer and prostatitis) as control group. Chi(2) test and non-conditional logistic regression were used for monovariate analysis and multivariate analysis, respectively. RESULTS: Data from monovariate analysis showed that BPH incidence was significantly related to body weight index, cigarette smoking, alcohol drinking, meal intake at the beginning of 1980's, hypertention and prostatitis, respectively. While multivariate non-conditional logistic analysis showed that BPH was related to five factors: prostatitis (OR = 5.577, 95% CI: 2.147 - 14.482), monthly intake of meats at the beginning of 1980's (OR = 4.930, 95% CI: 2.404 - 10.111), diastolic blood pressure (OR = 1.050, 95% CI: 1.017 - 1.083), cigarette smoking (OR = 0.660, 95% CI: 0.500 - 0.872) and alcohol consumption (OR = 0.650, 95% CI: 0.480 - 0.881). CONCLUSION: Prostatitis, monthly excessive intake of meats at the beginning of 1980's and high diastolic blood pressure were possible risk factors for BPH, while heavy cigarette smoking and alcohol consumption were possible protective factors for BPH.

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Surgical management for benign prostatic hyperplasia: indications, techniques, and results.

Diagnostic possibilities have improved with urodynamic studies and rectal ultrasound. Many more patients with benign prostatic hyperplasia (BPH) need urodynamic investigation because 25% of men with symptoms have no prostatic obstruction. Ultrasound is quite accurate in choosing the proper surgical technique. Open prostatectomy has largely been replaced by transurethral prostate resection (TURP). One reason is better surgical equipment, but another is that patients come earlier with smaller prostates. For obstructive prostates less than 20 g, transurethral incision (TUI) of the prostate is indicated. The results are as good as those of TURP. Primary success rates for TURP, TUI, and open prostatectomy are good, but in long-term follow-up studies, 10-25% of the patients have secondary procedures after 5-10 years.

Humans↗

[Residual fraction in the evaluation of bladder outlet obstruction resulting from benign prostatic hyperplasia].

OBJECTIVES: To study residual fraction (RF) in the bladder outlet obstruction (BOO) resulting from benign prostatic hyperplasia (BPH). METHODS: Fifty adult outpatients with BPH were evaluated. With ultrasound and uroflowmetry, prevoid volume (PV) and postvoid residual volume (PRV) and peak flow rate (Qmax) were determined. Linear dependence analysis of RF and Qmax, PRV and Qmax were conducted. RESULTS: The coefficient between RF and Qmax showed extremely negative correlation(r = -0.3859, P < 0.01). Also, PRV and Qmax showed significant negative correlation (r = -0.2831, P < 0.05). CONCLUSIONS: The greater the RF, the more serious the BOO, the poorer potency of bladder. It is recommended that RF be used as a good supplement to PVR in the routine non-invasive evaluation of BOO caused by BPH.

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Urodynamic and clinical effects of terazosin therapy in patients with symptomatic benign prostatic hyperplasia.

PURPOSE: We evaluated the urodynamic and clinical effects of terazosin in patients with symptomatic benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 45 patients who participated in a multicenter trial was evaluated with urodynamic pressure-flow studies before and after 26 weeks of treatment. RESULTS: Maximum flow rate and symptom score improved significantly in 22 patients with and 11 without bladder outlet obstruction who completed 26 weeks of treatment. In patients with bladder outlet obstruction the condition was significantly reduced and in patients without obstruction, significant urodynamic changes could not be detected. CONCLUSIONS: Terazosin treatment results in symptomatic relief and improved urinary flow in patients with and without bladder outlet obstruction, and in significant improvement in patients with urodynamically proved obstruction.

Adrenergic alpha-Antagonists↗

Benign prostatic hyperplasia: a population-based study.

To evaluate the incidence and outcome of initial surgery for benign prostatic hyperplasia (BPH) and to clarify the natural occurrence and progression of such urologic diseases, two studies have been conducted in a free-living population in Rochester, MN. The first followed 330 men who had not been diagnosed with prostate or bladder cancer at the time of prostatectomy. All surgery subjects were area residents and between 46 and 95 years of age (mean age 70 years). Among the operated subjects, 14 (4.2%) had serious intraoperative complications, 32 (9.7%) were rehospitalized for urologic complications within 30 days after surgery, and 13 (3.9%) experienced other serious complications in that same time period. Blood transfusions within 30 days of surgery were necessary in 45 patients (14%). The risk of reoperation within 6 years of the initial surgery was calculated at 15.1% (95% CI: 9.7, 20.6). On the basis of age- and sex-specific mortality statistics for Rochester, short- and long-term postoperative mortality was not statistically significantly different from that expected. Results of the second study are not yet available. This population-based evaluation of the natural history of urologic disease is expected to clarify the relative utility of various treatment options and provide a useful perspective on the management of BPH.

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Doxazosin gastrointestinal therapeutic system: a review of its use in benign prostatic hyperplasia.

Doxazosin, a well established treatment in patients with bothersome lower urinary tract symptoms from benign prostatic hyperplasia (BPH), is available in a new controlled-release formulation, doxazosin gastrointestinal therapeutic system (GITS). Doxazosin GITS (Cardura XL, Cardular PP Uro, Diblocin PP Uro) has an altered pharmacokinetic profile, which allows a higher initial dosage to be used than with the standard formulation and less titration steps to reach a clinically effective dosage. In two large, double-blind, randomised studies (one was placebo-controlled) in patients with BPH, doxazosin GITS (4-8 mg once daily) was as effective as the standard formulation (2-8 mg once daily), and both were more effective than placebo, after 13 weeks' treatment in improving symptom scores, health-related quality of life (HR-QOL), and maximum urinary flow rate (Qmax). Doxazosin GITS was at least as well tolerated as the standard formulation of doxazosin in clinical studies in patients with BPH.

Adrenergic alpha-Antagonists↗

Durability of results obtained with transurethral microwave thermotherapy in the treatment of men with symptomatic benign prostatic hyperplasia.

To assess the durability of the results of transurethral microwave thermotherapy (TUMT) for symptomatic benign prostatic hyperplasia (BPH), we have reviewed publications describing trials with at least 3 years of follow-up. For men treated only by TUMT, improvement in symptoms and quality of life appears to be maintained for at least 4 to 5 years. Improvement in peak flow rates is modest but is generally maintained, particularly after higher-energy therapies. These results represent responders, and a crucial question is the need for additional treatments. With lower-energy treatment, this is common: between 50% and 60% within 3 to 5 years. With higher-energy TUMT, the retreatment rate appears to be less, approximating 20% within 3 to 4 years. When comparing these results with those of transurethral resection, it should be noted that there is a significant failure rate with surgery, and even if failure is more common with TUMT, men may be prepared to accept this risk rather than the greater morbidity of prostatectomy.

Humans↗

[Effect and safety of transrectal 137 CS gamma-rays in the treatment of benign prostatic hyperplasia].

OBJECTIVE: To evaluate the effect and safety of transrectal 137Cs gamma-ray therapy for benign prostatic hyperplasia. METHODS: Thirty cases of BPH were treated by transrectal 137Cs gamma-rays. RESULTS: After 6 months there was significant improvement in the maximum urine flow, IPSS and QOL (P < 0.05). But no significant changes were observed in the prostate volume and residual urine (P > 0.05). CONCLUSION: Transrectal 137Cs gamma-ray therapy is safe and effective in the treatment of BPH.

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The safety and efficacy of terazosin for the treatment of benign prostatic hyperplasia.

The efficacy and safety of terazosin was evaluated in 28 normotensive patients with symptomatic benign prostatic hyperplasia (BPH) ranging in age between 52-72 years. The parameters utilized to assess the efficacy of terazosin included peak and mean urinary flow rate, micturition symptom score and the patients' global assessment of symptomatic improvement. The dose of terazosin was titrated to 5 mg/day over a one-month interval, provided significant adverse drug reactions were not observed. Twenty-two (79%) of the 28 patients completed the terazosin dose-titration study, 5 (18%) were withdrawn owing to adverse drug reactions and 1 (3%) was withdrawn owing to poor compliance. Overall, the mean systolic blood pressure, increased 3 mmHg (3%) and the diastolic blood pressure decreased 1 mmHg (1%). The peak and mean urinary flow rates increased 63% and 61%, respectively. The obstructive and irritative symptom scores decreased 62% and 33%, respectively. The improvements in urinary flow rates and symptom scores were clinically and statistically significant. Overall, 61% of the patients indicated that their voiding symptoms were markedly improved on terazosin and 64% of the participants have elected to voluntarily continue on terazosin indefinitely. In conclusion, terazosin represents a safe and effective treatment for symptomatic BPH.

Adrenergic alpha-Antagonists↗

Microwave thermotherapy in patients with benign prostatic hyperplasia and chronic urinary retention.

OBJECTIVE: To evaluate microwave thermotherapy as a treatment option for benign prostate hyperplasia (BPH) in patients with chronic retention and an indwelling catheter. PATIENTS AND METHODS: 24 unselected patients, 53-91 years old (mean age 73 years) with chronic urinary retention and an indwelling catheter were treated with ProstaLund Feedback TreatmentR. Patients had had an indwelling catheter for 1-12 months prior to treatment. ProstaLund Feedback Treatment is an enhanced microwave treatment where the actual intraprostatic temperature is monitored and used to control the microwave power. RESULTS: 19 (80%) of the 24 patients were successfully relieved of their indwelling catheter with satisfactory peak flow, residual urine and symptom score. Treatment failed in 5 (20%) out of the 24 cases. The reasons of failure were identified in all 5 cases and indicate that the method may be less suitable in case of a median lobe or large protruding lobes into the bladder. There were no serious complications such as bleeding requiring hospital intervention, sepsis or urine incontinence. Isolated cases of urinary infection occurred. CONCLUSION: The satisfying outcome of a 1-hour-long out-patient procedure for this patient category suggests that ProstaLund Feedback Treatment may be a good alternative to surgery for BPH patients with chronic retention and an indwelling catheter.

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Reproducibility of uroflow measurement: experience during a double-blind, placebo-controlled study of doxazosin in benign prostatic hyperplasia.

OBJECTIVES: To evaluate the interindividual and intraindividual variation of uroflow measurements in men with benign prostatic hyperplasia (BPH). METHODS: A total of 147 men with clinical evidence of BPH underwent two uroflow measurements at each of two screening visits prior to recruitment into a placebo-controlled study of doxazosin in the treatment of BPH. The maximum and mean flow rates were determined on each occasion. Differences in the mean value of both parameters for the cohort were examined. The intraindividual variability was evaluated using intraclass correlation coefficients and differences in maximum uroflow at each visit were examined. RESULTS: Uroflow measurements for the cohort were reproducible and there was no clinically significant difference in maximum and mean flow rate on each occasion. However, the intraclass correlation coefficients for the mean and maximum flow rate varied between 0.70 and 0.82, indicating that intraindividual variation accounted for a substantial component of the total variation in uroflow observed among these patients. For many individuals, test-retest differences were clinically relevant. CONCLUSIONS: For a group of patients, maximum and mean uroflow measurements are reproducible. However, for an individual, these parameters are subject to clinically significant variation and a single measurement may not be representative. This may be important when considering the need for therapeutic intervention.

Adrenergic alpha-Antagonists↗

Postoperative MRI in patients undergoing interstitial laser coagulation thermotherapy of benign prostatic hyperplasia.

OBJECTIVE: We conducted MRI of the effects of laser-induced thermal therapy (LITT) in benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Eighteen patients (average age 64 years) were examined with MRI 24-48 h before and after LITT of BPH. Sagittal and axial T2-weighted FSE MR images were evaluated for signs of coagulation necrosis in the prostate gland and the presence of intra- and extraprostatic edema. RESULTS: Coagulation areas showed as a hypointense central core with a hyperintense rim. Intraprostatic edema led to a volume increase of 18-108% both in the central and in the total gland. Periprostatic edema was severe in preprostatic and prevesical tissue as well as lateral to the prostate, moderate in the presacral space, and mild perirectally and dorsal to the prostate. Follow-up examinations 2 weeks to 6 months after LITT in five patients showed decrease of coagulation necrosis volume, prostate size, and edema. CONCLUSION: MRI appears to be a reliable method to monitor LITT effects in patients with BPH.

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Reproducibility of pressure-flow variables in patients with symptomatic benign prostatic hyperplasia.

OBJECTIVES: To study the reproducibility of pressure-flow studies in patients with symptomatic benign prostatic hyperplasia and to investigate if the reproducibility is influenced by the method of intravesical pressure measurement, that is, transurethral catheterization versus suprapubic puncture. METHODS: The within-patient variation of maximum urinary flow rates and detrusor pressure at maximum flow was investigated in 25 patients in whom 2 (transurethral group) or 3 (suprapubic group) sequential voidings during urodynamic investigation were analyzed. RESULTS: The within-patient variation of pressure-flow values was evaluated by the intraclass correlation coefficient, which was 0.71 for maximum urinary flow rate and 0.84 for detrusor pressure, suggesting a relatively high degree of reproducibility. However in 26% of the patients, the maximum flow rates changed by more than 3 mL/s or the detrusor pressure by more than 20 cm H2O during the repeated tests. There was no significant difference in the within-patient variation of pressure-flow values between the suprapubic group and the transurethral group. CONCLUSIONS: In larger clinical trials where the assessment of treatment effects between groups is desired, a single pressure-flow test is sufficient. In the individual patient, a single pressure-flow curve is of limited value due to a considerable within-patient variation of the test and, for these patients, multiple consecutive tests are recommended for diagnosis of intravesical obstruction and assessment of individual patient's response to treatment.

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Measuring disease-specific health status in men with benign prostatic hyperplasia. Measurement Committee of The American Urological Association.

In preparation for an outcomes study of benign prostatic hyperplasia (BPH), two measures of disease-specific health status were developed to supplement a symptom score and overall health status measures. The symptom problem index (SPI) captures how troublesome patients find their urinary symptoms. The BPH impact index (BII) measures how much their urinary problems affect various domains of health. A prospective revalidation of the refined instruments (N = 108 BPH patients and 50 controls) documented that both indices had good internal consistency (Cronbach's alpha = 0.88 and 0.79, respectively) and test-retest (r = 0.88 for both) reliabilities, correlated strongly with symptom scores (r = 0.86 and 0.77), and discriminated between BPH and control subjects (receiver-operating characteristic areas = 0.87 and 0.85, respectively). These indices were nearly as responsive as symptom scores in 50 men actively treated for BPH, and much more responsive than a non-disease-specific General Health Index (GHI), a Mental Health Index (MHI), and an Activity Index (AI). Finally, these measures capture most of the health status significance of BPH symptoms. In linear regression models constructed to predict scores on the GHI, MHI, and AI, symptom scores added little explanatory power to the SPI and, particularly, to the BII. These measures help clarify how BPH affects overall health status and function. Such measures have an important role to play in studies of the outcomes of treatment for BPH, and probably for other conditions that interfere with health status and function.

Adult↗

Simultaneous administration of vardenafil and tamsulosin does not induce clinically significant hypotension in patients with benign prostatic hyperplasia.

OBJECTIVES: To assess the pharmacodynamic effects of coadministered vardenafil and tamsulosin in patients with benign prostatic hyperplasia (BPH) undergoing stable tamsulosin therapy. METHODS: In this Phase 1, placebo-controlled, two-stage, two-way, crossover study, 22 patients undergoing stable (longer than 4 weeks) tamsulosin therapy for BPH (18 using 0.4 mg and 4 using 0.8 mg tamsulosin daily) received vardenafil 10 mg (or placebo), followed by vardenafil 20 mg (or placebo), simultaneously with tamsulosin. The mean maximal change from baseline with vardenafil use versus placebo was evaluated for supine and standing blood pressure and heart rate for up to 6 hours after dosing. RESULTS: In patients receiving vardenafil 10 mg, the mean maximal change from baseline versus placebo in supine systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate was -4.5 mm Hg (95% confidence interval [CI] -8.2 to -0.8), -2.3 mm Hg (95% CI -4.9 to 0.4), and 3.7 beats per minute (95% CI 1.1 to 6.3), respectively. In patients receiving vardenafil 20 mg, the mean maximal change from baseline versus placebo in supine SBP, DBP, and heart rate was -4.0 mm Hg (95% CI -6.3 to -1.8), -2.9 mm Hg (95% CI -5.6 to -0.2), and 0.8 beats per minute (95% CI -1.2 to 2.9), respectively. These hemodynamic changes were similar to those obtained in the standing position. Two placebo patients and 1 vardenafil 10-mg patient had a drop of 20 mm Hg or more in standing DBP; 1 vardenafil 10-mg patient had a standing SBP drop of 30 mm Hg or more. No patient exhibited symptomatic hypotension (SBP less than 85 mm Hg with dizziness). Three patients receiving vardenafil 20 mg/tamsulosin 0.4 mg reported dizziness, but never had an SBP of less than 95 mm Hg. No serious adverse events were reported. CONCLUSIONS: In this study, no evidence was found that coadministered vardenafil and tamsulosin induced clinically significant hypotension in patients with BPH.

Adrenergic alpha-Antagonists↗

Long-term results of microwave thermotherapy for symptomatic benign prostatic hyperplasia.

PURPOSE: To study the long-term outcomes of men with moderately severe symptomatic benign prostatic hyperplasia (BPH) who were treated with transurethral microwave thermotherapy (TUMT) with the Dornier Urowave machine. PATIENTS AND METHODS: A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association (AUA) Symptom Score of >or=13, and a peak urinary flow rate (Qmax) of <or=12 mL/sec were enrolled in a multicenter randomized, double-blind, sham-controlled trial. Sham and active treatments were conducted under local anesthesia as an outpatient procedure. Patients were followed up at 1 week and at 1, 3, and 6 months. Patients in the sham-treatment arm who still met the initial enrollment criteria were then offered active treatment. The 6-month interim analysis of the safety and efficacy of this treatment has been previously reported (Urology 1998;51:19). Patients were then followed at 6-month intervals out to 60 months after treatment. At our center, 34 men (mean age 64+/-6 years) continued on the recommended long-term follow-up protocol. RESULTS: Among the 34 men from our center initially entered in the study, 15 completed the entire 5-year follow-up. Four of the men available for follow-up at the 5-year mark were on alpha-blocker medication, and six men had required transurethral surgery for symptom relief. At 5 years, this cohort of patients maintained improvement in AUA Score (from 20.5+/-6.2 to 11.5+/-5.0; P<0.001) and Quality of Life score (from 3.7+/-1.3 to 1.9+/-1.0; P<0.001) but showed no significant improvement in Qmax (8.2+/-1.9 mL/sec to 8.4+/-4.3 mL/sec). At 5 years, 11 of the 15 patients available for review had not required additional therapy. CONCLUSIONS: While improvement in voiding symptoms and Quality of Life scores were maintained without the need for adjuvant treatment in approximately one third of men 5 years after TUMT, a significant number had required salvage therapies for symptom relief.

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[Relationship of socioeconomic factors with medical utilization for lower urinary tract symptoms and benign prostatic hyperplasia in a South Korean community].

OBJECTIVES: We wanted to evaluate the medical underutilization for benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) among Korean elderly men and we wanted to determine their associated factors. METHODS: This study was conducted on 239 men with LUTS and 116 men with BPH who were compatible with the diagnostic criteria from a total of 641 participants. These participants were over 50 years old and they were randomly chosen in a community-based study for estimating the prevalence of BPH. Using a self-reported questionnaire, we surveyed the sociodemographics, health status, quality of life, lower urinary tract symptoms, medical utilization and reasons for not seeking treatment. RESULTS: Only 27.6% of the men with LUTS and 31.0% of the men with BPH reported having visited a doctor for urinary symptoms. The reasons for not visiting a doctor were, in order of responses from the group with LUTS: 'considered the symptoms as a part of the normal ageing process', 'not enough time to visit a doctor', 'financial difficulty' and 'the symptoms were not severe or bothersome'. Regarding BPH, the responses were the same as those of the group with LUTS however, 'financial difficulty' placed second. Among the men with experience of visiting a doctor for urinary symptoms, 33.3% of those with LUTS and 28.1% of those with BPH were not treated. The most common reason in both groups was 'the symptoms were not severe to be treated'. On a multiple logistic regression analysis, the larger size household (odds ratio (OR) 3.03, 95% confidence interval (Cl) = 1.40-6.54) and an unsatisfactory quality of life related with urinary symptoms (OR 2.98, 95% CI = 1.23-7.21) were associated with medical utilization in the group of LUTS. For BPH, the current employment status was related with the medical utilization (OR 2.80, 95% CI = 1.10-7.11), in addition to the larger size household (OR 3.24, 95% CI = 1.14-9.21). CONCLUSIONS: Many men with urinary symptoms do not visit a doctor. This medical underutilization for people with LUTS and BPH may be associated with economic status in Korea.

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