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ABSTRACT: To report the conclusion of the Think Thank on Neurourology discussions during the first ICI-RS meeting in 2009.
During a 3-day meeting a group of specialists discussed evidence-based medicine in neurourology and made suggestions for future research.
In the vast majority of patients with neurological disease bladder dysfunction occurs. The actual rules of diagnosis and treatment lack a study related evidence base. From a long list of possible research subjects, prevalence, detrusor pressure, imaging, catheterization and surgery have been first discussed.
In each of these subjects, research items are suggested which can help to improve the care in this patient group.
Neurourology and Urodynamics 04/2010; 29(4):662-9. · 2.96 Impact Factor
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P Abrams,
K E Andersson,
L Birder,
L Brubaker,
L Cardozo,
C Chapple,
A Cottenden,
W Davila,
D de Ridder,
R Dmochowski, [......],
I Nygaard,
C Payne,
A Smith,
D Staskin,
S Tekgul,
J Thuroff,
A Tubaro,
D Vodusek, A Wein,
J J Wyndaele
Neurourology and Urodynamics 12/2009; 29(1):213-40. · 2.96 Impact Factor
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ABSTRACT: This manuscript summarizes the work of Committee 10 on neurologic bladder and bowel of the International Consultation on Incontinence in 2008-2009. As the data are very large the outcome is presented in different manuscripts. This manuscript deals with neurologic urinary incontinence.
Through in debt literature review all aspects of neurological urinary incontinence were studied for levels of evidence. Recommendations for diagnosis and treatment, and for future research were made.
Pathophysiology was summarized for different levels of lesions. For epidemiology, specific diagnostics, conservative treatment and surgical treatment of neurologic urinary incontinence, levels of evidence and grades of recommendation were made following ICUD criteria.
Though data are available that advice and guide in the management of urinary incontinence in neurologic patients, not many data have a high level of evidence or permit a high grade of recommendation. More and well-structured research is needed.
Neurourology and Urodynamics 12/2009; 29(1):159-64. · 2.96 Impact Factor
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ABSTRACT: This manuscript summarizes the work of Committee 10 on neurologic bladder and bowel of the International Consultation on Incontinence in 2008-2009. As the data are very large the outcome is presented in different manuscripts. This manuscript deals with neurologic fecal incontinence (FI).
Through in debt literature review all aspects of neurologic urinary and FI were studied for levels of evidence. Recommendations for diagnosis and treatment, and for future research were made.
Pathophysiology was summarized for different levels of lesions. For epidemiology, specific diagnostics, conservative treatment, and surgical treatment of neurologic FI levels of evidence and grades of recommendation were made.
Though data are available that advice and guide in the management of FI in neurologic patients, not many data are with a high level of evidence or high grade of recommendation. More and well-structured research is needed.
Neurourology and Urodynamics 12/2009; 29(1):207-12. · 2.96 Impact Factor
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P. Abrams,
K.E. Andersson,
L. Birder,
L. Brubaker,
L. Cardozo,
C. Chapple,
A. Cottenden,
W. Davila,
D. de Ridder,
R. Dmochowski, [......],
I. Nygaard,
C. Payne,
A. Smith,
D. Staskin,
S. Tekgul,
J. Thuroff,
A. Tubaro,
D. Vodusek, A. Wein,
J.J. Wyndaele
Neurourology and Urodynamics 12/2009; 29(1):213 - 240. · 2.96 Impact Factor
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ABSTRACT: The impact of body mass index on tumor characteristics and treatment failure in prostate cancer is not well understood in diverse ethnic groups. We evaluated the effect of body mass index in African-American and European American patients from a radical prostatectomy cohort between 1995 and 2004 with regard to tumor histopathological characteristics and biochemical relapse-free survival.
A total of 924 patients were studied to evaluate whether obese men (body mass index greater than 30) had different preoperative and postoperative tumor characteristics or biochemical relapse-free survival compared to nonobese men. There were 784 European American and 140 African-American patients analyzed using failure time models, adjusted for age, preoperative prostate specific antigen, tumor stage and race.
Mean and median followup was 42 and 36 months, respectively. African-American men were significantly more obese than European American men. Mean body mass index was 29.0 in African-American and 28.1 in European American men (p = 0.003). African-American men (OR 2.30, 95% CI 1.04-5.1) were more likely to have higher tumor stage on final pathology. Obesity was a risk factor for biochemical failure in African-American men (adjusted hazard ratio 5.49, 95% CI 2.16-13.9) but not in European American men (HR 1.41, 95% CI 0.96-2.08), and this difference was statistically significant (p value for interaction 0.036).
Obesity is associated with poorer tumor prognostic characteristics and decreased biochemical relapse-free survival, particularly in African-American men. These data suggest that obesity may in part explain the poorer prostate cancer prognosis seen in African-American men compared to other racial and ethnic groups.
The Journal of Urology 12/2007; 178(5):1939-44; discussion 1945. · 3.75 Impact Factor
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European Urology Supplements - EUR UROL SUPPL. 01/2005; 4(3):141-141.
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International Journal of Radiation Oncology Biology Physics - INT J RADIAT ONCOL BIOL PHYS. 01/2004; 60(1).
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ABSTRACT: We evaluated the ability of previously defined risk groups to predict prostate specific antigen (PSA) outcome 10 years after radical prostatectomy in patients diagnosed with clinically localized prostate cancer during the PSA era.
Between 1989 and 2000, 2,127 men with clinically localized prostate cancer underwent radical prostatectomy, including 1,027 at Hospital of the University of Pennsylvania (study cohort) and 1,100 at Brigham and Women's Hospital (validation cohort). Cox regression analysis was done to calculate the relative risk of PSA failure with the 95% confidence interval (CI) in patients at intermediate and high versus low risk. The Kaplan-Meier actuarial method was used to estimate PSA outcome 10 years after radical prostatectomy.
Compared with low risk patients (stages T1c to 2a disease, PSA 10 ng./ml. or less and Gleason score 6 or less) the relative risk of PSA failure in those at intermediate (stage T2b disease or PSA greater than 10 to 20 ng./ml. or less, or Gleason score 7) and high (stage T2c disease, or PSA greater than 20 ng./ml. or Gleason score 8 or greater) risk was 3.8 (95% CI 2.6 to 5.7) and 9.6 (95% CI 6.6 to 13.9) in the study cohort, and 3.3 (95% CI 2.3 to 4.8) and 6.3 (95% CI 4.3 to 9.4) in the validation cohort. The 10-year PSA failure-free survival rate in the 1,020 patients in the low, 693 in the intermediate and 414 in the high risk groups was 83%, 46% and 29%, respectively (p <0.0001).
Based on 10-year actuarial estimates of PSA outcome after radical prostatectomy 3 groups of patients were identified using preoperative PSA, biopsy Gleason score and 1992 clinical T category.
The Journal of Urology 12/2001; 166(6):2185-8. · 3.75 Impact Factor
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ABSTRACT: The normal bladder functions, storage and elimination of urine, are dependent on neural circuits in the brain and spinal cord that coordinate the activity of the detrusor and that of the smooth and striated muscles of the outflow region. Disturbances at different levels may cause the overactive bladder (OAB) syndrome, characterized by urge, frequency and urge incontinence. Knowledge about the mechanisms controlling both normal and abnormal micturition is mandatory for the detection of targets for pharmacological intervention. Such targets may be found in the central nervous system (CNS) or peripherally. Several CNS transmitters can modulate voiding, but few drugs with a defined CNS site of action have been demonstrated to be clinically useful. Traditionally, drugs for treatment o
World Journal of Urology 12/2001; 19(5):294-8. · 2.41 Impact Factor
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ABSTRACT: Whether early detection using prostate-specific antigen (PSA) and digital rectal examination (DRE) compared with DRE alone will reduce prostate cancer mortality awaits the results of ongoing prospective randomized trials. However, the impact that early detection could have on prostate cancer-specific survival can be estimated by assuming that PSA failure after radical prostatectomy (RP) will translate into death from prostate cancer.
The study population consisted of 1274 men with clinically localized prostate cancer who underwent RP in Boston, Massachusetts or Philadelphia, Pennsylvania between 1989 and 2000 and had a preoperative PSA level greater than 4 but not more than 10 ng/mL. The primary endpoint was actuarial freedom from PSA failure (defined as PSA outcome).
The relative risk of PSA failure after RP for patients diagnosed with a PSA of greater than 4 to 5, 5 to 6, 6 to 7, or 7 to 8 ng/mL compared with greater than 8 up to 10 ng/mL was 0.3 (95% confidence interval [CI] 0.2 to 0.5), 0.5 (95% CI 0.4 to 0.8), 0.6 (95% CI 0.4 to 0.9), or 0.9 (95% CI 0.6 to 1.3), respectively. On the basis of the estimates of the 5-year PSA outcome, patients with a biopsy Gleason score of 5 or 6 (781 of 1274; 61%) consistently benefited from RP performed when the PSA at diagnosis was greater than 4 to 7 ng/mL compared with greater than 8 to 10 ng/mL (93% versus 78%, P <0.0001). A benefit to early detection was not found for the vast majority (266 of 312; 88%) of patients who had a biopsy Gleason score of 7 or higher.
Early detection using both PSA and DRE-based screening may benefit men who present with biopsy Gleason score 5 or 6 prostate cancer and a PSA level greater than 4 to 7 ng/mL compared with greater than 8 up to 10 ng/mL. This finding awaits validation from ongoing prospective randomized trials.
Urology 10/2001; 58(3):406-10. · 2.43 Impact Factor
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ABSTRACT: Previously available antimuscarinic therapies for overactive bladder are poorly tolerated due to a high incidence of adverse events, notably dry mouth. Tolterodine is a bladder-selective, antimuscarinic agent for the treatment of frequency, urgency, and urge incontinence that characterize overactive bladder. In a 9-month open-label study, the safety, tolerability, and clinical efficacy of tolterodine 2 mg twice daily was evaluated in 854 patients with overactive bladder symptoms who had completed one of four 12 week randomized, controlled trials of tolterodine. Safety and tolerability were assessed in terms of adverse events and clinical/laboratory variables. Efficacy was assessed using micturition diaries and patient perception of their bladder condition. In all, 70% of patients remained on treatment for 9 months. Dry mouth was the most frequently reported adverse event, occurring in 28% of patients (intensity: 19% mild, 7% moderate, 2% severe). A total of 9% of patients withdrew due to adverse events. Dosage reduction occurred in 13% of patients. Significant improvements (P < 0.0001) in micturitions per 24 h (-22%), urge incontinence episodes per 24 h (-76%) and volume voided per micturition (+22%) were observed after 9 months of treatment, with 65% of patients reporting an improvement in perception of their bladder problems. The incidence of adverse events and improvements in micturition diary variables during open-label treatment were comparable with those observed during a 12 week randomized treatment. It was concluded that tolterodine is well tolerated and maintains its clinical efficacy during 9 months of treatment. The high proportion of patients remaining on treatment indicates that tolterodine is an effective long-term treatment for overactive bladder.
World Journal of Urology 05/2001; 19(2):141-7. · 2.41 Impact Factor
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ABSTRACT: To evaluate the efficacy and tolerability of a new extended-release (ER), once-daily, capsule formulation of tolterodine, relative to placebo and the existing immediate-release (IR), twice-daily, tablet formulation, for treatment of the overactive bladder.
This was a double-blind, multicenter, randomized, placebo-controlled trial. One thousand five hundred twenty-nine patients (81% women) with urinary frequency (eight or more micturitions every 24 hours) and urge incontinence (five or more episodes per week) were randomized to oral therapy with tolterodine ER 4 mg once daily (n = 507), tolterodine IR 2 mg twice daily (n = 514), or placebo (n = 508) for 12 weeks. Efficacy was assessed at the end of the treatment period on the basis of the micturition diary variables. Tolerability and safety were assessed by evaluating the adverse events, electrocardiogram parameters, laboratory values, and treatment withdrawals.
Tolterodine ER 4 mg once daily (P = 0.0001) and tolterodine IR 2 mg twice daily (P = 0.0005) both significantly reduced the mean number of urge incontinence episodes per week compared with placebo. The median reduction in these episodes as a percentage of the baseline values was 71% for tolterodine ER, 60% for tolterodine IR, and 33% for placebo. The ER formulation was 18% more effective than the IR formulation (P <0.05). Treatment with both formulations of tolterodine was also associated with statistically significant improvements in all other micturition diary variables compared with placebo. For both formulations, the mean decreases in micturition frequency (P <0.0079) and pad usage (P <0.0145) were significant, and the mean volume voided per micturition increased (P = 0.0001). The rate of dry mouth (of any severity) was 23% for tolterodine ER, 30% for tolterodine IR, and 8% for placebo. The overall dry mouth rate for patients taking tolterodine ER was 23% lower than for tolterodine IR (P <0.02), and the rate of severe dry mouth in the ER group was only 1.8%. The rates of withdrawal were comparable for the two active groups and the placebo group. No safety concerns were noted.
Tolterodine ER 4 mg once daily is effective and well tolerated in the treatment of overactive bladder with no safety concerns. Tolterodine ER demonstrated an improved efficacy for reducing urge incontinence episodes and a lower frequency of dry mouth compared with the existing IR twice-daily formulation.
Urology 04/2001; 57(3):414-21. · 2.43 Impact Factor
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ABSTRACT: Tolterodine is a bladder-selective antimuscarinic agent designed for the treatment of overactive bladder. Traditional antimuscarinic therapies are poorly tolerated due to a high incidence of anticholinergic adverse events and consequently few patients remain on long term therapy.
To evaluate the long term efficacy and tolerability of tolterodine in patients with symptoms of overactive bladder.
Twelve-month open-label extension of 4 randomised, placebo-controlled, double-blind, multinational, multicentre trials of 4 weeks' duration.
714 patients (aged 18 to 92 years) with symptoms of overactive bladder who completed the double-blind portion of the studies.
Tolterodine 2 mg twice daily for up to 12 months.
Micturition diary variables: number of micturitions per 24 hours, number of urge incontinence episodes per 24 hours, mean urine volume voided per micturition. Safety variables: adverse events, study discontinuation rate.
A total of 441 patients (62%) completed 12 months' open-label treatment with tolterodine, which significantly reduced the number of micturitions per 24 hours [mean change -2.4, 95% confidence interval (CI) -2.7 to -2.2, median change -20%, p < 0.0001] and number of urge incontinence episodes per 24 hours (mean change -1.3, 95% CI -1.6 to -1.0, median change -74%, p < 0.0001), while the mean volume voided per micturition was significantly increased (+33 ml, 95% CI +28 to +38, median change +18%; p < 0.0001). 41% of patients reported dry mouth (27% mild, 10% moderate, 3% severe). Dosage reduction to 1 mg twice daily was required in 23% of patients. 15% of patients withdrew from the study due to adverse events, with 5% having associated dry mouth.
The high percentage of patients completing 12 months' treatment indicates that tolterodine is an effective and well tolerated agent for long term treatment of overactive bladder.
Drugs & Aging 02/2001; 18(7):551-60. · 2.67 Impact Factor
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A V D'Amico,
R Whittington,
S B Malkowicz,
D Schultz,
B Silver,
L Henry,
M Hurwitz,
I Kaplan,
C J Beard,
J E Tomaszewski,
A A Renshaw, A Wein,
J P Richie
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ABSTRACT: The clinical utility of the percent of positive prostate biopsies in predicting prostate-specific antigen (PSA) outcome following radical prostatectomy (RP), or external beam radiation therapy (RT), for men with PSA detected, or clinically palpable prostate cancer was investigated. After accounting for the established prognostic significance of the PSA level, biopsy Gleason score and the clinical T-stage, the percent of positive prostate biopsies added clinically significant information regarding time to PSA failure following RP. These findings were validated in the intermediate risk patients using an independent surgical and radiation data set. Prostate Cancer and Prostatic Diseases (2000) 3, 259-264
Prostate cancer and prostatic diseases 01/2001; 3(4):259-264. · 2.10 Impact Factor
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ABSTRACT: Endorectal magnetic resonance imaging (MRI) of the prostate is sometimes performed before radical prostatectomy but to our knowledge its role for predicting outcome after radical prostatectomy is not yet established. We evaluated the clinical usefulness of endorectal MRI for predicting time to prostate specific antigen (PSA) failure after radical prostatectomy in 1,025 consecutive men with clinically localized or PSA detected prostate cancer. Our analysis controlled for PSA level, biopsy Gleason score, clinical T stage and percent of positive biopsies.
Using Cox regression analysis we prospectively assessed time to PSA failure to determine the role of endorectal MRI in predicting PSA outcome after radical prostatectomy at our institution, where an expert prostate magnetic resonance radiologist is available. The main outcome measure was actuarial freedom from PSA failure.
Endorectal MRI did not add clinically meaningful information in 834 of our 1,025 cases (81%) after accounting for the prognostic value of PSA, biopsy Gleason score, clinical T stage and percent of positive biopsies. However, this modality provided a clinically and statistically relevant stratification of 5-year PSA outcome in the remaining 191 patients at intermediate risk based on established prognostic factors. Specifically when endorectal MRI was interpreted as indicating extracapsular versus organ confined disease the relative risk of PSA failure was 3.6 (95% confidence interval 2.0 to 6.3), and 5-year actuarial freedom from PSA failure was 33% versus 72% (p <0.0001).
Despite expert radiological interpretation endorectal MRI had potential clinical value in less than 20% of the cases in our study after accounting for established prognostic factors. While further study of the value of this modality for predicting clinical outcome after radical prostatectomy should be performed in this select cohort, routine use of endorectal MRI cannot be justified based on these data.
The Journal of Urology 09/2000; 164(3 Pt 1):759-63. · 3.75 Impact Factor
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A V D'Amico,
R Whittington,
S B Malkowicz,
Y H Wu,
M H Chen,
M Hurwitz,
P W Kantoff,
J E Tomaszewski,
A A Renshaw, A Wein,
J P Richie
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ABSTRACT: Prostate-specific antigen (PSA) failure within 2 years after radical prostatectomy (RP) has been shown to be a clinically significant predictor of distant failure. This study was performed to estimate 2-year PSA failure rates on the basis of readily available clinical and pathologic factors to identify patients for whom effective adjuvant systemic therapy is needed.
A Cox regression multivariable analysis was used to determine whether the percentage of positive prostate biopsies, PSA level, and the pathologic findings at RP in 1,728 men provided clinically relevant information about PSA outcome after RP. A bootstrapping technique with 2,000 replications was used to provide 95% confidence intervals for the predicted 2-year PSA failure rates, which were determined on the basis of the independent clinical and pathologic predictors of PSA outcome.
The independent predictors of time to PSA failure included a percentage of positive prostate biopsies of greater than 34% (P: < or =.009), PSA level greater than 10 ng/mL (P: < or =.01), seminal vesicle invasion (P: =. 02), prostatectomy Gleason score of 8 to 10 (P: =.04), and positive surgical margins (P: =.0001). Predictions of 2-year PSA failure rates and bootstrap estimates of the 95% confidence intervals were arranged in a tabular format, stratified by independent clinical and pathologic predictors of PSA outcome.
Patients who are most likely to benefit from effective adjuvant systemic therapy after RP can be identified using readily available clinical and pathologic data.
Journal of Clinical Oncology 09/2000; 18(18):3240-6. · 18.37 Impact Factor
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ABSTRACT: Early (< or = 2 years) prostate specific antigen (PSA) failure after radical prostatectomy (RP) has been shown to predict for distant failure. After excluding patients with the pathologic predictors of early PSA failure, an analysis of PSA failure free (bNED) survival was performed to identify patients who may benefit from the use of postprostatectomy radiation therapy (RT).
Of 1,028 patients treated with RP for clinically localized prostate carcinoma between 1989 and 1999, 862 (84%) had either organ confined (OC), specimen confined (SC), or margin positive disease with negative seminal vesicles (SV) and a prostatectomy Gleason score < or = 7. A Cox regression multivariate analysis was performed in these patients evaluating the ability of the extent of extracapsular extension (ECE) (into but not through the capsule, SC focal ECE, SC established ECE, margin positive) and prostatectomy Gleason score (2-6 vs. 7) to predict time to postoperative PSA failure.
SC focal ECE (P = 0.0017), SC established ECE (P < 0.0001), and margin positive disease (P < 0.0001) were significant predictors of time to postoperative PSA failure, whereas prostatectomy Gleason score and disease extending into but not through the capsule were not. Five-year bNED rates were 90%, 88%, 69%, 45%, and 33% for patients with OC, into but not through capsule, SC focal ECE, SC established ECE, and margin positive prostate carcinoma, respectively.
Patients with SC ECE or margin positive prostate carcinoma and a prostatectomy Gleason score < or = 7 with no evidence of SV invasion may benefit from adjuvant postoperative RT.
Cancer 06/2000; 88(9):2110-5. · 4.77 Impact Factor
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ABSTRACT: Early (2 years or less) prostate-specific antigen (PSA) failure has been shown to predict for distant failure. The independent clinical predictors of time to postoperative PSA failure were used to identify prostate cancer patients at high risk for early PSA failure.
A Cox regression multivariable analysis was used to determine whether additional predictive information was provided by the endorectal coil magnetic resonance imaging (erMRI) T-stage when controlling for the established prognostic factors in predicting the time to postoperative PSA failure in 977 men with palpable (T2) or PSA-detected (T1c) prostate cancer.
Preoperative PSA (P = 0.0001), percentage of positive prostate biopsies (P= 0.0001), erMRI T-stage (P = 0.0001), biopsy Gleason score (P = 0.0015), and clinical stage T2c disease (P = 0.004) were independent predictors of time to postoperative PSA failure. Two-year PSA failure rates derived from the Cox regression model and bootstrap estimates of the 95% confidence intervals are presented in nomogram format stratified by the preoperative PSA, percentage of positive prostate biopsies, erMRI T-stage, and the biopsy Gleason score.
Patients at high risk for early PSA failure and subsequent distant progression include men with erMRI T3 disease and 3 or more of 6 cores positive for a Gleason score 6 or higher disease when the PSA is more than 10 but not more than 20 ng/mL and any Gleason score when the PSA is more than 20 ng/mL. Men with erMRI T2 disease and 3 or more of 6 cores positive for a Gleason score 8 or higher disease and who have a PSA more than 20 ng/mL are also at high risk. Neoadjuvant therapy trials in these select patients may be justified.
Urology 05/2000; 55(4):572-7. · 2.43 Impact Factor
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ABSTRACT: To determine the clinical utility of the percentage of positive prostate biopsies in predicting prostate-specific antigen (PSA) outcome after radical prostatectomy (RP) for men with PSA-detected or clinically palpable prostate cancer.
A Cox regression multivariable analysis was used to determine whether the percentage of positive prostate biopsies provided clinically relevant information about PSA outcome after RP in 960 men while accounting for the previously established risk groups that are defined according to pretreatment PSA level, biopsy Gleason score, and the 1992 American Joint Committee on Cancer (AJCC) clinical T stage. The findings were then tested using an independent surgical database that included data for 823 men.
Controlling for the known prognostic factors, the percentage of positive prostate biopsies added clinically significant information (P <.0001) regarding time to PSA failure after RP. Specifically, 80% of the patients in the intermediate-risk group (1992 AJCC T2b, or biopsy Gleason 7 or PSA > 10 ng/mL and </= 20 ng/mL) could be classified into either an 11% or 86% 4-year PSA control cohort using the preoperative prostate biopsy data. These findings were validated in the intermediate-risk patients using an independent surgical data set.
The validated stratification of PSA outcome after RP using the percentage of positive prostate biopsies in intermediate-risk patients is clinically significant. This information can be used to identify men with newly diagnosed and clinically localized prostate cancer who are at high risk for early (</= 2 years) PSA failure and, therefore, may benefit from the use of adjuvant therapy.
Journal of Clinical Oncology 03/2000; 18(6):1164-72. · 18.37 Impact Factor
