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Biomedical subjects

C G Roehrborn

Publications and source records attributed to C G Roehrborn.

At least 19 recordsLinked to original sources
PubMed1999

Urinary flow rate recording: the impact of a single dose of a diuretic on clinic logistics and flow rate parameters.

PURPOSE: We determine the impact of a single dose of a diuretic given to patients scheduled for flow rate recording on clinic waiting time and flow rate parameters, and whether such practice induces artifacts in recording independent of those inherent in repeat recordings. MATERIALS AND METHODS: A total of 99 volunteers with a mean age plus or minus standard deviation of 54 +/- 10.9 years with no known urological condition participated in an open label, crossover study. On 2 separate occasions they came to the clinic for a flow rate recording, and were randomized to receive 20 mg. furosemide upon arrival at the first or second visit. Clinic waiting time, pre-void bladder volume, voided volume, maximum flow rate and other parameters were captured in a database and analyzed. RESULTS: Independent of diuretic use an increase in voided volume and maximum flow rate (19.8 to 21.2 ml. per second) was noted from the first to second visit. Diuretic use independent of sequence induced an increase in voided volume and significant reduction in waiting time (155 versus 81 minutes, p <0.001) without affecting maximum flow rate (19.9 versus 21.1 ml. per second, p = 0.058). Diuretic use on the second visit enhanced the learning effect on maximum flow rate, while first visit use negated the learning effect on the second visit. Waiting time reduction was significant independent of sequence. The positive correlation between voided volume and maximum flow rate remained unchanged with or without the diuretic. CONCLUSIONS: Repeat flow rate recordings are associated with a measurable learning effect leading to an increase in maximum flow rate. The use of 20 mg. furosemide reduces waiting time without inducing additional artifacts or significant changes in flow rate parameters. This practice is recommended for busy offices or clinical research centers to enhance urine flow, patient satisfaction and ultimately compliance with care.

Adult↗
PubMed1999

Neoadjuvant and adjuvant alpha-blockade improves early results of high-energy transurethral microwave thermotherapy for lower urinary tract symptoms of benign prostatic hyperplasia: a randomized, prospective clinical trial.

OBJECTIVES: Improved long-term results with respect to symptoms, voiding function, and quality of life (QOL) in patients with lower urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH) are achieved with targeted high-energy transurethral microwave thermotherapy (TUMT) compared with alpha-blocker treatment alone. However, maximal improvement after TUMT is not attained until 3 to 6 months after treatment. Measures to provide earlier symptom relief and improved voiding function and QOL would add to the clinical utility of TUMT. The objective of the present study was to determine whether neoadjuvant and adjuvant alpha-blockade is capable of accelerating a post-TUMT decrease in LUTS of patients with BPH. METHODS: In this randomized, prospective study of 81 patients with LUTS of BPH, 41 underwent TUMT with neoadjuvant and adjuvant tamsulosin (0.4 mg daily) treatment, and 40 had TUMT alone. International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), and QOL score were determined before treatment and at periodic intervals thereafter up to 12 weeks after TUMT. RESULTS: Mean IPSS values in the TUMT plus tamsulosin group at 2 weeks (14.0, 95% confidence interval [CI] 13.1 to 14.9) and 6 weeks (8.6; 95% CI 7.7 to 9.5) were 15% and 24% lower, respectively, than those at 2 weeks (16.5, 95% CI 15.6 to 17.4) and 6 weeks (11.3, 95% CI 10.4 to 12.2) in the TUMT-alone group (P<0.0005). However, by the final evaluation at 12 weeks, no significant difference between the groups in mean IPSS was evident. A similar temporal pattern of difference between the two study groups was also observed in QOL score. No significant between-group difference in mean Qmax was evident after TUMT. Urinary retention 1 week or more in duration occurred in 5 (12%) of 40 TUMT-alone group patients compared with 1 (2%) of 41 TUMT plus tamsulosin group patients. CONCLUSIONS: Neoadjuvant and adjuvant alpha-blocker treatment results in significantly greater early symptom reduction and QOL score improvement after TUMT, adding to the clinical utility of this minimally invasive treatment modality. In addition, post-TUMT complications such as urinary retention may be reduced.

Adrenergic alpha-Antagonists↗
PubMed1999

Effect of scrambling on the short-term reliability of the American Urological Association Symptom Index.

OBJECTIVES: To determine the degree of attention patients pay to the wording of symptom scoring instruments and to determine the short-term reliability of the American Urological Association Symptom Index (AUA SI). METHODS: The AUA SI was administered to 111 volunteers with a mean age+/-SD of 50.8+/-16.4 years (range 23 to 83) in the standard formatting. Without debriefing, the same volunteers were given the AUA SI a second time within 2 weeks. By sequential assignment, 65 of the subjects were given the AUA SI in the same standard format, and for the remaining 46, the sequence of the questions was scrambled and the order of the answers reversed for the second administration. In addition, the Benign Prostatic Hyperplasia Impact Index (BPH II) and the quality of life (QOL) question were answered and urinary flow rates were performed on both occasions to compare the short-term variability between the "subjective" symptom score and the "objective" flow rate recordings. RESULTS: In this group of volunteers with a mean age of 50.8 years, the mean AUA SI was 11.7 points. The mean values in the unscrambled group were 12.4 and 12.9 (NS) and in the scrambled group 10.5 and 10.2 (NS) for the two administrations. Cumulative frequency distribution of differences were nearly identical. Similarly, there were no differences in the mean values for the two administrations in either group for the BPH II, the QOL question, or the peak flow rate. The reproducibility was excellent for each of the individual seven questions in both groups. There was no effect of age (younger or older than 50 years) on the reproducibility, although in general the variability of the scores was higher in older men, presumably due to a higher score in the first assessment. CONCLUSIONS: Subjects pay relatively close attention to the questions of symptom score questionnaires. The reproducibility for each individual question, as well as for the entire score, was very high in the original unscrambled and in the scrambled version. In addition, the short-term variability of the AUA SI is comparable to that of the flow rate recording. These observations should give confidence to those using such scores in clinical practice and clinical research.

Adult↗
PubMed1999

Serum prostate-specific antigen concentration is a powerful predictor of acute urinary retention and need for surgery in men with clinical benign prostatic hyperplasia. PLESS Study Group.

OBJECTIVES: Prostate-specific antigen (PSA) is produced exclusively in the prostate gland and is currently the most useful clinical marker for the detection of prostate cancer. In this report, we examine whether serum PSA is also a predictor of important benign prostatic hyperplasia (BPH)-related outcomes, acute urinary retention (AUR), and the need for BPH-related surgery. METHODS: Three thousand forty men were treated with either placebo or finasteride in a double-blind, randomized study of 4-year duration. Serum PSA was measured at baseline, and baseline prostate volume was measured in a 10% subset of 312 men. Probabilities and cumulative incidences of AUR and BPH-related surgery, as well as reduction in risk of events with finasteride, were calculated for the entire patient population, stratified by treatment assignment, baseline serum PSA, and prostate volume. RESULTS: The risk of either needing BPH-related surgery or developing AUR ranged from 8.9% to 22.0% during the 4 years in placebo-treated patients stratified by increasing prostate volume and from 7.8% to 19.9% when stratified by increasing serum PSA. In comparison with symptom scores, flow rates, and residual urine volume, receiver operating characteristic curve analyses showed that serum PSA and prostate volume were the most powerful predictors of spontaneous AUR in placebo-treated patients (area under the curve 0.70 and 0.81, respectively). Finasteride treatment reduced the relative risk of needing surgery or developing AUR by 50% to 74% and by 43% to 60% when stratified by increasing prostate volume and serum PSA, respectively. CONCLUSIONS: Serum PSA and prostate volume are powerful predictors of the risk of AUR and the need for BPH-related surgery in men with BPH. Knowledge of baseline serum PSA and/or prostate volume are useful tools to aid physicians and decision makers in predicting the risk of BPH-related outcomes and choosing therapy for BPH.

Acute Disease↗
PubMed1999

Serum prostate-specific antigen as a predictor of prostate volume in men with benign prostatic hyperplasia.

OBJECTIVES: To assess the utility of prostate-specific antigen (PSA) as a predictor of prostate volume by characterizing the relationship between prostate volume and serum PSA in men with symptomatic benign prostatic hyperplasia (BPH) and no evidence of prostate cancer, stratified by decade of life. METHODS: Placebo-controlled multicenter trials in patients with BPH and a safety study in normal young men provided baseline measurements of serum PSA and prostate volume. The analyses included patients with a baseline prostate volume measured by either transrectal ultrasound (TRUS) or magnetic resonance imaging and baseline serum PSA. A common central laboratory was used for all but one of the individual studies; both laboratories used the Hybritech method. Patients 80 years of age or older were excluded. Patients with a baseline serum PSA greater than 10 ng/mL were excluded to reduce the likelihood of including occult prostate cancer cases. The patients in the BPH trials were screened at baseline by digital rectal examination (DRE) and serum PSA. Those with suspicious findings underwent TRUS-guided biopsy; only patients with negative biopsies are included in these analyses. RESULTS: The analyses included 4627 patients, 4448 from the BPH trials and 179 from the safety study. The men in the BPH trials were older (mean age+SE, 63.7+0.10 years) than the men in the safety study (mean age + SE, 30.8+/-0.43), had larger prostates (mean volume+/-SE, 43.7+/-0.38 mL versus 26.3+/-0.49 mL in the safety study), and had higher serum PSA values (mean+/-SE, 2.6+/-0.03 ng/mL versus 0.7+/-0.39 ng/mL in the safety study). The relationship between prostate volume and serum PSA was evaluated using only the BPH trial data. Prostate volume and serum PSA have an age-dependent log-linear relationship (ie, their logarithms are linearly related, and the parameters of the relationship depend on age). Older men tend to have a steeper rate of increase in prostate volume with increasing serum PSA (P < 0.00 for differences between slopes), and there was a slight tendency for PSA density to increase with age. Receiver operating characteristic (ROC) curves were constructed to evaluate the ability of serum PSA to predict threshold prostate sizes in men with BPH. The ROC curve analyses revealed that PSA had good predictive value for assessing prostate volume, with areas under the curve ranging from 0.76 to 0.78 for various prostate volume cutoff points (30, 40, and 50 mL). Conclusions. Prostate volume is strongly related to serum PSA in men with BPH and no evidence of prostate cancer, and the relationship depends on age. Since treatment outcome or risk of long-term complications depend on baseline prostate volume, serum PSA can estimate the degree of prostate enlargement sufficiently accurately to be useful for therapeutic decision making. To achieve a specificity of 70% while maintaining a sensitivity between 65% and 70%, approximate age-specific criteria for detecting men with prostate glands exceeding 40 mL are PSA > 1.6 ng/mL, >2.0 ng/mL, and >2.3 ng/mL for men with BPH in their 50s, 60s, and 70s, respectively.

Adult↗
PubMed1999

Prospective determination of the hormonal response after cessation of luteinizing hormone-releasing hormone agonist treatment in patients with prostate cancer.

OBJECTIVES: To determine the hormonal (luteinizing hormone [LH] and testosterone) and biochemical (serum prostate-specific antigen [PSA]) response to withdrawal of luteinizing hormone-releasing hormone (LHRH) agonists in patients who received more than 2 years of LHRH therapy for advanced prostate cancer. METHODS: Fourteen patients with clinical Stage T3 or higher prostate cancer and no evidence of clinical or biochemical progression, who had received 2 years or more of LHRH therapy, were enrolled at the time of their scheduled 3-month depot injection. Patients underwent history, physical examination, and measurement of serum PSA, LH, and testosterone at baseline, monthly for 3 months, and then every 3 months for 1 year following LHRH withdrawal. RESULTS: The mean age of patients was 70.3 years (range 56 to 84). Patients previously received LHRH agonist for a mean of 38.6 months (range 25 to 82). All patients had castrate levels of testosterone (median 10.0 ng/dL) and suppressed LH levels (median 0.1 mIU/mL) at baseline. Median baseline PSA was 0.15 ng/mL. On multiple groupwise comparison, there was no significant change (compared with baseline) in LH or testosterone until 6 months after withdrawal and no change in PSA throughout the duration of the study (median PSA at 1 2 months 0.30 ng/mL). Despite significant increases in LH and testosterone when compared with baseline beginning at 6 months, both LH and testosterone remained markedly suppressed, with median testosterone remaining in the castrate range at both 6 and 9 months and significantly below the lower limit of normal at 12 months (median 111.0 ng/dL). Despite no statistically significant change for the entire cohort in serum PSA, a rising PSA was noted in 4 patients between 3 and 9 months, and LHRH therapy was reinitiated. The remaining patients continued to have suppressed LH and testosterone, with 4 patients remaining in the castrate range at 12 months. CONCLUSIONS: The recovery of function of the hypothalamic-pituitary-testicular axis after prolonged LHRH administration is variable. Castrate levels of testosterone and suppressed LH may persist even up to 1 year after discontinuing LHRH. These results have significant implications regarding the interpretation of clinical trials incorporating neoadjuvant and adjuvant hormonal therapy. Further studies are needed to expand on these preliminary observations and should also address the feasibility of incorporating LHRH withdrawal into clinical practice.

Aged↗
PubMed1999

Prospective randomized comparison of high energy transurethral microwave thermotherapy versus alpha-blocker treatment of patients with benign prostatic hyperplasia.

PURPOSE: We compare directly the efficacy and safety of targeted high energy transurethral microwave thermotherapy with alpha-blocker treatment for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: In this randomized prospective study 52 patients with symptomatic BPH received terazosin and 51 underwent high energy transurethral microwave therapy with topical anesthesia. Patient evaluation included determination of International Prostate Symptom Score (I-PSS), peak flow rate and quality of life score before transurethral microwave therapy or terazosin and periodically up to 6 months thereafter. RESULTS: At 2-week followup the terazosin group transiently exhibited significantly greater improvement than the transurethral microwave therapy group in mean values of all 3 primary efficacy parameters of I-PSS, peak flow rate and quality of life score. At 12 weeks and 6 months this pattern was reversed, and the transurethral microwave therapy group achieved significantly greater improvement than the terazosin group in mean I-PSS, peak flow rate and quality of life score. By 6 months 78.4, 64.7 and 84.3% of the transurethral microwave therapy group demonstrated a 50% or greater improvement in I-PSS, peak flow rate and quality of life score, respectively, compared with 32.7, 9.6 and 40.4% of the terazosin group, respectively. Nine patients in the terazosin group and 1 in the transurethral microwave therapy group withdrew from study because of side effects or lack of treatment efficacy. CONCLUSIONS: Terazosin afforded more rapid improvement in symptoms, voiding function and quality of life in BPH patients. High energy transurethral microwave therapy offered markedly superior clinical outcomes at 12 weeks to 6 months.

Adrenergic alpha-Antagonists↗
PubMed1999

Long-term followup of the North American multicenter UroLume trial for the treatment of external detrusor-sphincter dyssynergia.

PURPOSE: We determine the long-term efficacy and safety of the UroLume stent as minimally invasive treatment for external detrusor-sphincter dyssynergia in spinal cord injured men. MATERIALS AND METHODS: A total of 160 spinal cord injured men with a mean age plus or minus standard deviation of 36.3 +/- 12.1 years (range 16 to 74) were prospectively treated with an endoprosthesis at 15 centers as part of the North American UroLume trial for external detrusor-sphincter dyssynergia. Urodynamic parameters, including voiding pressure, residual urine volume and bladder capacity, were compared before treatment and at 1, 2, 3, 4 and 5 years after treatment. RESULTS: Mean voiding pressure was 75.1 +/- 28.2 cm. water before treatment in the 160 patients, and 37.4 +/- 23.9 at year 1 in 97, 39.5 +/- 22.2 at year 2 in 84, 42.6 +/- 27.3 at year 3 in 61, 46.3 +/- 33.2 at year 4 in 57 and 44.2 +/- 28.9 cm. at year 5 in 41 after stent insertion (p <0.001). Residual urine volume decreased after stent placement and was maintained throughout the 5-year followup (p <0.001). Mean cystometric capacity remained constant from 269 +/- 155 before insertion to 337 +/- 182 ml. 5 years later (p = 0.17). Hydronephrosis and autonomic dysreflexia improved or stabilized in most patients with functioning stents. Stent explant was necessary in 24 patients (15%), of whom 4 (16.7%) had another stent implanted. CONCLUSIONS: The UroLume stent demonstrates long-term safety and efficacy for the treatment of external detrusor-sphincter dyssynergia. The outcome was similar in men with and without previous sphincterotomy.

Adolescent↗
PubMed1998

The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group.

BACKGROUND: Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, is not known. METHODS: In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men. RESULTS: During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the finasteride group (reduction in risk with finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group (P<0.001). Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001). CONCLUSIONS: Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the risk of surgery and acute urinary retention.

5-alpha Reductase Inhibitors↗
PubMed1998

Advanced transitional cell carcinoma of the upper urinary tract: patterns of failure, survival and impact of postoperative adjuvant radiotherapy.

PURPOSE: We review the outcome of patients with advanced stage III or IV transitional cell carcinoma of the upper urinary tract and the impact of postoperative radiotherapy. MATERIALS AND METHODS: We identified 74 patients who were treated surgically with curative intent for stage III (49) or IV (25) transitional cell carcinoma of the upper urinary tract. Median followup was 21 months (range 1 to 236) for all patients and 60 months (range 29 to 172) for those alive at last contact. A median dose of 40 Gy. adjuvant radiotherapy was delivered to the tumor bed and regional nodes of 15 patients (30%) with stage III and 13 (52%) with stage IV disease. RESULTS: The actuarial 5-year overall and disease specific survival for patients with stage III disease was 28 and 40%, respectively. Median disease specific survival was 37 months. Median overall and disease specific survival for patients with stage IV disease was 7 months. Isolated local recurrence was identified in 5 of 49 patients with stage III and only 1 of 25 with stage IV disease. The 5-year actuarial disease specific survival rate in patients with stage III disease whether or not they were treated with postoperative radiotherapy was 45 versus 40%, respectively. For patients with stage IV disease median survival was 7 and 9 months for those who were and those who were not treated with postoperative radiotherapy, respectively. CONCLUSIONS: Patients with stages III and IV transitional cell carcinoma of the upper urinary tract have a high risk of disease relapse and cancer mortality. The major clinical feature is distant failure with isolated local relapse uncommon following initial aggressive surgical therapy. There is no survival benefit with postoperative adjuvant radiotherapy. More effective systemic adjuvant therapy is necessary to improve the outcome of these patients.

Adult↗
PubMed1998

Safety and efficacy of the Alexandrite laser for the treatment of renal and ureteral calculi.

OBJECTIVES: To assess the safety and efficacy of the Alexandrite laser for intracorporeal lithotripsy of renal and ureteral stones in conjunction with ureterorenoscopy or percutaneous nephrostolithotomy. METHODS: We retrospectively analyzed the records of 137 patients with 169 calculi in 143 renoureteral units who were treated with the Alexandrite laser via a retrograde (91.5%) or antegrade (8.5%) endoscopic approach. RESULTS: Adequate intraoperative fragmentation of the stone was observed in 88.8% of the cases. No intraoperative complications were attributable to the laser. At a mean follow-up of 34 days, the overall stone-free rate was 74.4%. The stone-free rate for ureteral stones (n = 115) was 80%, whereas the stone-free rate for renal stones (n = 22) was only 44%. In the best subgroup of ureteral stones (10 mm or less in the distal ureter), the stone-free rate was 97.4%. CONCLUSIONS: The Alexandrite laser is a safe modality for intracorporeal lithotripsy and is highly effective for ureteral stones less than 10 mm in size.

Adolescent↗
PubMed1998

Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Aged↗
PubMed1998

The so-called "placebo effect" in benign prostatic hyperplasia treatment trials represents partially a conditional regression to the mean induced by censoring.

OBJECTIVES: To study the variability of assessment instruments (symptom questionnaires and flow rate recordings) in healthy volunteers during repeat administration in short intervals. To study the effect of inclusion criteria-based censoring of patients during screening for benign prostatic hyperplasia (BPH) treatment trials on the outcome of subsequent tests. METHODS: One hundred forty-five male volunteers without known prostatic diseases with a mean age of 52 years (range 23 to 83) were given the American Urological Association (AUA) Symptom Index (SI), BPH Impact Index (II). Quality of Life (QOL) score, and a flow rate recording twice 10 to 20 days apart without any healthcare intervention. Data were collected and analyzed after typical BPH trial criteria were applied to the first test, and patients who did not "qualify" were censored. RESULTS: Good correlation exists between two closely spaced administrations of the AUA SI, BPH II, QOL score, and flow rate recordings in healthy male volunteers with correlation coefficients between 0.73 and 0.89. Censoring patients and excluding them from the analysis of the second test based on typical BPH trial criteria induces a regression to the mean phenomenon, which results in an artificial improvement in these outcome parameters. The magnitude of the improvement increases as the selection and censoring criteria tighten. The mean differences between the first and second test range from 1.4 to 1.7 mL/s for the peak flow rate, from -1.0 to -1.4 for the AUA SI, and from -0.4 to -0.8 for the BPH II. All these differences induced solely by censoring with resulting regression to the mean are statistically significant. CONCLUSIONS: Censoring of patients based on inclusion and exclusion criteria is typical for BPH treatment trials. One of the under-recognized effects of censoring is a regression to the mean, which leads to an apparent improvement in the outcome parameters assessed. In both placebo or sham-controlled trials, as well as in clinical series without controls, one must keep this effect and its relative magnitude in mind, and interpret the data from such trials with appropriate caution.

Adult↗
PubMed1998

Proposed cutoff values to define bladder outlet obstruction in women.

OBJECTIVES: There is no accepted urodynamic definition of outlet obstruction in women. Currently, the diagnosis is made on the basis of history and radiographic and endoscopic findings. The goal of this study is to design a pressure-flow nomogram (PdetQmax/Qmax) and define cut-off values for obstruction. METHODS: Two groups were studied prospectively in an open study: 124 control and 35 clinically obstructed patients. All had a complete history, physical examination, normal neurologic evaluation, cystoscopy, voiding cystography, and urodynamics-with-pressure-flow study. Pressure-flow plot and receiver operator characteristic curves (ROCs) were constructed to determine optimal cut-off values to predict obstruction for peak flow rate (Qmax) and detrusor pressure at maximal flow (PdetQmax). RESULTS: The etiology of obstruction was previous anti-incontinence surgery (n = 13), large cystocele (n = 11), urethral stricture (n = 6), and other (n = 5). On the basis of ROC curves, using cut-off values of Qmax of 15 mL/s or less and 12 mL/s or less, sensitivity was 85.7% and 71.4%, and specificity 78.2% and 90.3%, respectively. Using cut-off values of PdetQmax of more than 25 and more than 30 cm H2O, sensitivity was 74.3% and 71.4%, and specificity 79.8% and 88.7%, respectively. Using a combined cut-off value of Qmax of 1 5 mL/s or less and PdetQmax of more than 20 cm H2O, sensitivity was 74.3% and specificity was 91.1%. CONCLUSIONS: Based on this prospective, controlled study, preliminary cut-off values were obtained for refining the definition of outlet obstruction in women.

Female↗
PubMed1998

Transurethral needle ablation for benign prostatic hyperplasia: 12-month results of a prospective, multicenter U.S. study.

OBJECTIVES: To report the safety and efficacy of the transurethral needle ablation (TUNA) procedure for the treatment of clinical benign prostatic hyperplasia (BPH). METHODS: One hundred thirty patients with BPH were enrolled in two identical protocols and treated by the TUNA procedure. Entry criteria included an American Urological Association symptom index (AUA SI) of 13 points or higher and a peak flow rate of 12 mL/s or less. Patients were followed up for 12 months. Efficacy parameters included the AUA SI, AUA problem index, BPH impact index (BPH II), quality of life (QOL) score, and peak flow rate. At each visit, side effects were elicited. Follow-up data are available for 93 patients at 12 months. All patients were given intraurethral lidocaine augmented by oral and/or parenteral sedation. No patient received spinal or general anesthesia. RESULTS: All patients tolerated the procedure well, and there were no deaths. Forty-one percent of patients (n = 53) had a catheter placed immediately after the procedure. At 12 months, the AUA SI had decreased from 23.7 to 11.9 (P < 0.0001) and the BPH II from 7.5 to 2.5 (P < 0.0001), whereas the peak flow rate had increased from 8.7 to 14.6 mL/s (P < 0.0001). Irritative voiding symptoms were noted in 20 patients (16%) at some point during follow-up. Two patients reported erectile dysfunction, and 1 reported retrograde ejaculation. CONCLUSIONS: In this prospective study of 130 patients with clinical BPH and lower urinary tract symptoms, TUNA provided substantive and lasting improvement according to AUA SI, BPH II, and QOL scores as well as peak flow rate over 1 year. The TUNA procedure was well tolerated, with few major side effects and complications noted. Longer follow-up is needed to document the maintenance of clinical benefit beyond 12 months.

Aged↗
PubMed1998

Accurate determination of prostate size via digital rectal examination and transrectal ultrasound.

Previously, prostate size did not play a significant role in the choice of treatment for benign prostatic hyperplasia (BPH). It has been postulated that prostate size does not correlate with symptom severity, flow rate, or the presence or absence of obstruction. However, in a published study of community-dwelling men, the odds of having moderate to severe symptoms were five times higher for men with enlarged prostates than for those with normal prostates. Response to certain types of BPH therapy, especially finasteride, depends on actual prostate volume. Therefore, it is important to have a simple way to accurately determine if a patient's prostate is enlarged. In an analysis of four studies, there was a distinct underestimation of prostate size by digital rectal examination (DRE) when compared with transrectal ultrasound (TRUS) measurement. The underestimation of prostate volume increased with increasing TRUS volume, particularly if the volume was greater than 30 mL. The average underestimation was between 9% and 12% for prostate volumes 30 to 39 mL and between 17% and 27% for prostate volumes 40 to 49 mL. Because of these results, a prospective study is currently in progress to develop models or visual aids to assist physicians in more accurately predicting a threshold prostate volume via DRE.

Humans↗
PubMed1998

Meta-analysis of randomized clinical trials of finasteride.

A meta-analysis was recently published based on six randomized clinical trials of at least one year duration involving finasteride 5 mg and placebo in the treatment of men with clinical benign prostatic hyperplasia (BPH). In a pooled analysis, mean improvement in symptoms and urinary flow rate with finasteride were found to increase with increasing prostate size. This article reviews the previous publication of this meta-analysis, which indicated prostate volume is a key predictor of outcomes with finasteride treatment and suggested that finasteride is most effective in men with large prostates.

Finasteride↗