Urological Outcomes Research Articles

COMPARISON OF SECTION OF FILUM TERMINALE AND NON-NEUROSURGICAL MANAGEMENT FOR URINARY INCONTINENCE IN PATIENTS WITH NORMAL CONUS POSITION AND POSSIBLE OCCULT TETHERED CORD SYNDROME

Patients with persistent urinary incontinence and a normal location of the conus on magnetic resonance imaging scans may have occult tethered cord syndrome (OTCS). We compare outcomes in such patients after filum section versus nonoperative treatment. We performed a retrospective analysis of a consecutive series of children with refractory urinary incontinence and normal location of the conus who were offered section of the filum for treatment of possible OTCS. Eight children, aged 4.4 to 9.8 years, underwent filum section, with one child undergoing two such operations. Clinical urological improvement occurred in seven children at a mean follow-up period of 3.1 years, with improved urodynamic findings in four of the seven children tested postoperatively. Other non-urological back or lower limb abnormalities improved in five out of six children with such findings. None of the patients underwent additional urological operations after filum section. Seven children, aged 3.1 to 13.5 years, all of whom had abnormal urodynamic findings, did not undergo filum section. At a mean follow-up period of 3.3 years, two patients had urological improvement and three patients had undergone bilateral ureteric reimplantations. Other non-urological back and/or lower limb abnormalities were present in five patients and did not improve. One patient had the filum cut after 8 years and improved thereafter. Section of the filum in children with refractory urinary incontinence and OTCS may produce better urological outcomes than continued medical management. A definitive answer to the question of whether section of the filum is better than non-neurosurgical medical management for children with OTCS awaits the conclusion of a randomized controlled trial.

Clinical Urological Outcomes Following Primary Tethered Cord Release in Children Younger Than 3 Years

Current practice at our institution is to recommend tethered cord release at diagnosis to prevent the onset or worsening of symptoms. Tethered cord release is frequently performed in children younger than 3 years who often have no urological manifestations. To our knowledge there are currently no long-term data on urological outcomes in this age group. We completed a retrospective review of 475 cases of tethered cord release performed at a single institution between 1995 and 2002. Of these surgeries 173 were performed in children younger than 3 years. Clinical outcomes, and preoperative and postoperative urodynamic and radiographic studies were evaluated. A total of 79 patients met study criteria. Average age at surgery was 9.6 months and average followup was 5.2 years (range 6 months to 11.2 years). At followup 49 patients (62.1%) had no urological complaints and 30 (38%) had urological problems. A total of 20 children (25.3%) had minor problems (constipation, delayed toilet training or other) and 10 (12.7%) had major problems (need for clean intermittent catheterization, febrile urinary tract infection or reflux). Of 66 patients 30 (45.5%) had abnormal preoperative urodynamics. One of 31 patients (3.2%) had hydronephrosis on preoperative ultrasound. Statistical analysis revealed that abnormal preoperative urodynamics and ultrasound were not predictive of major urological problems. Lipomatous dysraphism and preoperative musculoskeletal symptoms positively correlated with major urological problems (p = 0.0076 and 0.0484, respectively). The majority of children did not experience urological problems following tethered cord release. Only a small set of children had major urological problems. Children with lipomatous dysraphism and musculoskeletal symptoms were more likely to experience poor urological outcomes.

Contemporary Trends in Low Risk Prostate Cancer: Risk Assessment and Treatment

We updated national risk trends in prostate cancer with a focus on low risk tumors, reexamined trends in primary treatment for low risk tumors and substratified patients at low risk based on pretreatment clinical data. Data were abstracted from the CaPSURE registry. A total of 10,385 men were diagnosed between 1990 and 2006 with localized disease. Low risk was defined as prostate specific antigen 10 ng/ml or less, Gleason score 6 or less and clinical T stage 2a or less. Temporal trends were assessed for patient distribution among risk groups and in the low risk group for individual risk factors, Kattan nomogram prediction, Cancer of the Prostate Risk Assessment score and primary treatment. The ability of the Cancer of the Prostate Risk Assessment score to substratify low risk prostatectomy cases was evaluated with survival analysis. The proportion of low risk tumors in CaPSURE almost doubled from 27.5% in 1990 to 1994, to 46.4% in 2000 to 2001 but it has been relatively constant since then. A growing proportion of low risk tumors are cT1c and virtually all are Gleason score 6. Prostate specific antigen and the percent of positive biopsies decreased throughout the study period, as did the mean Cancer of the Prostate Risk Assessment score. The use of active surveillance increased from a nadir of 6.2% in 2000 to 2001, to 10.2% in 2004 to 2006. The use of prostatectomy also increased, whereas the use of androgen deprivation and radiation decreased. The likelihood of recurrence increased significantly with increasing Cancer of the Prostate Risk Assessment scores. Patients at low risk can be further substratified to identify those at very low risk based on clinical variables. The use of surveillance is increasing but overtreatment remains a concern in these patients.

Fetal myelomeningocele repair: urologic aspects

The notion that earlier surgical correction of congenital anomalies will lead to improved outcomes permeates throughout surgical literature. This review critically assesses some of the urologic evaluations in patients who have undergone fetal repair of their myelomeningoceles. Thus far, there are limited data to determine the effects of such a repair with respect to urologic outcome. Early data, though, have suggested that improvements are being noted in a cohort of patients who have undergone fetal repair of their myelomeningocele with respect to neurodevelopmental outcome and lower extremity neuromotor function. What remains to be seen is whether fetal surgery and the noted changes translate into long-term improvement. The efforts being put forth to critically assess the outcomes of such surgery are laudable and yet the end analysis may still leave the question unanswered.

Urogenitale Begleitverletzungen bei Beckenringfrakturen

Follow-up of patients with pelvic ring fractures and associated injuries of the lower urogenital tract was performed from January 2000 to October 2004. Analysis focused on incidence, fracture type, type of urogenital injury, associated intrapelvic lesions, mortality, and urologic outcome. The retrospective study included 18 of 111 patients (16.2%). Nine patients had a rupture of the urethra, six a rupture of the bladder, three a rupture of the penile root, and two a gonadal defect. The type of the pelvic ring fracture according to the AO classification was type A in 1, type B in 6, and type C in 11 cases. Fifteen patients (83.3%) were followed up clinically for a mean duration of 26 months (range: 12-66 months) after trauma. Seven patients were asymptomatic concerning the urogenital injury, five had erectile dysfunction, two had urethral stenosis, in one case associated with incontinence, and one patient with bilateral defect of the testicles was under hormone substitution therapy. Urogenital injuries, often associated with intrapelvic lesions in so-called complex pelvic trauma, are typical for high-grade pelvic ring fractures and have an essential prognostic value for the patient's morbidity and quality of life.

Postoperative Thrombotic Microangiopathy following Radical Cystectomy for Bladder Cancer

This report describes the perioperative management of disseminated intravascular coagulation occurring abruptly during a planned cystectomy for non-metastatic bladder papillary carcinoma. Peroperatively, profuse bleeding and an acute decrease in blood pressure were effectively treated by blood transfusions and fresh frozen plasma. Haematological tests indicated the presence of disseminated intravascular coagulation. On the following three days, acute renal failure, peripheral disseminated intravascular coagulation-related thrombocytopenia and haemolytic anemia with schistocytes were suggestive of thrombotic microangiopathy. Treatment by plasma exchange along with haemodialysis was commenced. An aetiological work-up remained negative. After 21 days of treatment, haemodialysis and plasma exchange were stopped. Urological outcome was favourable. The one-year follow-up did not show any residual renal insufficiency and laboratory parameters returned to normal. In the absence of evidence in favour of an infectious, drug-related or immunological aetiology, we postulated that this thrombotic microangiopathy was caused by disseminated intravascular coagulation and that the tumour manipulation during the surgical procedure was the triggering factor.

Does Surgical Release of Secondary Spinal Cord Tethering Improve the Prognosis of Neurogenic Bladder in Children With Myelomeningocele?

The diagnostic criteria for secondary tethering of the spinal cord in children with prior closure of an open spinal defect are not well defined. Urological, neurological or orthopedic deterioration during followup remains the only strong indicator for the diagnosis of this condition. However, the outcome of untethering surgery cannot always be predicted. The aim of this study was to determine neurourological outcome after secondary untethering surgery in children with myelomeningocele. Of 401 children with myelomeningocele followed at our multidisciplinary spina bifida clinic between 1996 and 2005, 56 (14%) were diagnosed with secondary tethering of the spinal cord (median age at diagnosis 4.1 years). The diagnosis was based on urological and neuro-orthopedic deterioration in 58% and 42% of children, respectively. Preoperative urological findings were compared with 6-month postoperative findings. Febrile urinary tract infection, upper tract dilatation and vesicoureteral reflux were preoperatively documented in 48.2%, 19% and 30% of the 56 children, respectively. At 6 months postoperatively urine cultures were sterile in 34% of patients and upper tract dilatation completely resolved in 45%. For all grades of vesicoureteral reflux complete resolution occurred in 47% of patients. Urodynamic parameters in terms of cystometric bladder capacity and detrusor leak point pressure substantially improved 6 months after untethering surgery (125 vs 170 ml and 69.1 vs 47.5 cm H2O, respectively, p < 0.05). Assessment of urodynamic findings in 19 children at 1 year failed to demonstrate a significant change in these parameters. A subgroup analysis according to patient age at untethering surgery revealed urodynamic improvement was more significant in children who were diagnosed and treated before age 7 years. Secondary tethering of the spinal cord is a major risk factor for urological and neurological deterioration in children with myelomeningocele. Close urological surveillance remains the most valuable tool in the early diagnosis. Our study shows that secondary untethering surgery may significantly improve urological outcome.

Evolución urológica de pacientes con agenesia de sacro: 20 años de seguimiento

Complete or partial sacral agenesis is a rare malformation consisting in the absence of one or more sacral vertebrae. It is part of a caudal regression syndrome and it may be associated with other congenital anomalies (Currarino Syndrome). It does not have an established etiology but is associated with insulin-dependent diabetes mellitus in the mother (1%). The objective of this is study was to retrospectively analyze the urological outcome of patients with sacral agenesis in our case series.Retrospective analysis of 14 patients between 1975 and 2005. We evaluated reason for consultation, urological status, continence outcome, urological complications, hospital admissions and number of office visits.No patient had history of diabetic mother The number of male/female patients were similar. Mean age at first visit was 13.2 years and main reason for consultation was urinary incontinence. 60% of the patients presented associated myelomeningocele. 70% had a normal upper urinary tract at the beginning of follow-up; 10 patients presented some degree of incontinence (70%). Mean follow-up was 19.7 years (7-30): 50% of the patients keep a normal upper urinary tract. All of them have presented symptomatic urinary tract infection. The main urological reason for hospital admission was programmed surgery (7). The mean number of visits per year was 1.9.Sacral agenesis is a rare congenital malformation requiring an early diagnosis to avoid mid-term urological complications. These patients need life-long urological follow-up. The mean reason for consultation is urinary incontinence secondary to neurogenic bladder which may be satisfactorily treated in most cases.

Prognostic factors affecting urologic outcome after untethering surgery for lumbosacral lipoma

The authors report results of preoperative and postoperative urodynamic studies (UDS) and prognostic factors of urologic outcome in cases of lumbosacral lipomas for which prolonged follow-up data were available. The present series includes 42 consecutive cases of lumbosacral lipoma in patients aged 2 months to 15 years who underwent untethering operation during the period from 1986 to 1997. All of them underwent preoperative and postoperative UDS. At the last follow-up (mean duration of follow-up 108 months, range 44 to 176 months), 26 cases maintained social continence with or without intermittent catheterization. Young age (< or =12 months) at operation, preoperative absence of urologic symptoms, and absence of neurologic abnormalities were significantly correlated with favorable urologic outcome. UDS in cases with lumbosacral lipomas is a valuable tool for detecting neurourologic abnormalities as well as for monitoring the postoperative course and guiding management. History taking and neurologic examination are also proved to be important aspects in the evaluation of children with lumbosacral lipomas, predictive of urologic outcome. Better urologic results are anticipated if surgery is performed when the child is 12 months old or younger.

Transverse Myelitis in Children: Long-Term Urological Outcomes

Urological complications are well documented in patients with traumatic spinal cord injury. We examined the long-term urological outcomes in a large population of children affected by transverse myelitis. We retrospectively reviewed the medical history, imaging studies and urodynamic findings in 22 children with transverse myelitis. Age at disease onset ranged from 3 months to 18 years (average 8.8 years). At a mean followup of 7.1 years 19 patients (86%) had persistent bladder dysfunction and 17 (77%) had persistent bowel dysfunction. Initial evaluation at least 1 month after disease onset revealed detrusor overactivity in 59% of patients, detrusor external sphincter dyssynergia in 41%, low compliance in 47% and detrusor leak point pressure greater than 40 cm water in 12%. Functional motor recovery and absence of lower extremity spasticity did not reflect normal urodynamic findings. Of the 19 patients with imaging available for review 5 (26%) had upper tract changes. One patient had development of chronic renal insufficiency. Low compliance (p = 0.02) and upper tract changes (p = 0.1) were more frequent in patients who started clean intermittent catheterization more than 2 years after disease onset. Persistent bowel and bladder dysfunction is common in transverse myelitis. Urodynamic abnormalities may be present despite normal neurological examination and absence of urinary symptoms. All pediatric patients with transverse myelitis require baseline renal ultrasound and urodynamic evaluation to guide treatment. Early institution of clean intermittent catheterization appears to preserve bladder compliance and decrease upper tract disease, and should be instituted at disease onset.

Long-term urological outcomes in paediatric spinal cord injury

Retrospective review. This retrospective review observes the evolution of bladder management by time and reports adult urological outcomes and complications in paediatric onset spinal cord injury (SCI). Spinal Injuries Unit RNOH Stanmore. In total, 10 traumatic SCI patients with mean age at injury of 13.6 years underwent treatment, for a mean period of 13.1 years. Characteristics of injury were noted. Two diagnostic subgroups, neurogenic detrusor overactivity (NDO), and acontractile detrusor were made. Complications, treatment changes, operative procedures with follow-up were noted. In group 1 (6/10 patients) with NDO, five had DSD. Initial bladder management was reflex/urge voiding (n=4), suprapubic catheterisation (SPC), (n=1) and self-intermittent catheterisation (SIC), (n=1). Two patients had multiple upper tract complications with decreased renal function, two recurrent symptomatic urinary infections and one; bladder calculus. In total, 12 operative procedures were performed to treat complications and change bladder management to, SIC+oxybutynin (n=3), ileal conduit (n=1), sacral anterior root stimulator implant (SARSI), (n=1), voiding on urge (n=1). In group 2 (4/10 patients) with a-contractile detrusor two had low compliance. Initial bladder management was SIC (n=3) and voiding on urge/straining (n=1). Two patients converted from SIC to permanent catheter drainage and reported complications. Incidental kidney stone was diagnosed in one. A total of four interventions were carried out with final management of SIC (n=2), voiding on urge/straining (n=1) and Mitrofanoff+ileocystoplasty (n=1). Bladder management in paediatric SCI is dependent on neurological level and type of injury; it changes with growth and is affected by changes in bladder management.

Correlations between Longitudinal Changes in Transitional Zone Volume and Measures of Benign Prostatic Hyperplasia in a Population-Based Cohort

ObjectiveTo determine whether measures of transitional zone volume (TZV) are more strongly associated than total prostate volume with longitudinal urologic outcomes. MethodsIn 1990, 2,115 randomly selected Caucasian men from Olmsted County, Minnesota (USA) completed validated questionnaires during a home visit. A 25% subsample underwent clinical evaluation that included transrectal ultrasonography, assessment of serum prostate-specific antigen levels, and maximum urinary flow rates. Examinations and questionnaires were repeated biennially through 2004. TZV measures were taken at the fifth through eighth visits. Men with at least one TZV measurement were included in this study (n=336). ResultsChanges in TZV correlated weakly with changes in peak urinary flow rate and urinary symptoms. After accounting for age and change in total prostate volume, change in TZV added no information to models that predict changes in urinary symptoms and peak urinary flow rates. Men who experienced the most rapid annual changes in TZV were not more likely to experience more rapid changes in urinary symptoms or maximum flow rate. ConclusionTracking changes in TZV over time may be unlikely to provide a good surrogate measure for the development of benign prostatic hyperplasia.

Late second trimester assessment of pyelectasis (SERP) to predict pediatric urological outcome is improved by checking additional features

Objective. Counseling for pyelectasis in the late 2nd trimester is usually based only upon assessing the antero-posterior (AP) width of the renal pelvis. We hypothesized that checking additional features would better predict postnatal outcome.Study design. Ultrasound (<24 weeks gestational age (GA)) and newborn outcome data collected prospectively since 1986 were analyzed retrospectively. We determined if outcome predictions in kidneys with a sonographically evident renal pelvis (SERP), which had evaluation of additional features (e.g., renal and bladder lengths, presence of a dilated ureter or dilated calyces) are more accurate than those that did not have these features.Results. There were 286 fetuses studied with pediatric follow-up of an average of 6.5 years. There were 338 exams providing 459 ultrasound images with SERP. Additional features were not assessed in 183 fetuses; however 103 fetuses did have evaluation of additional features. These features were categorized as abnormal (92) or as normal (11). Fetuses with SERP and abnormal additional features required extensive urological care or died 6.1 times more often than fetuses in which additional features were not examined (p < 0.001) and 12.9 times more often when additional features were normal (p < 0.001).Conclusion. Fetal kidneys with SERP (<24 weeks GA) and an abnormal additional ultrasound feature had extensive pediatric care significantly more often than when such features were not evaluated or were normal.

Relation between sacral sparing and long term urological outcome in open spina bifida

Relation between sacral sparing and long term urological outcome in open spina bifida

Long-term urological outcome of patients presenting with persistent cloaca.

Persistent cloaca is a complex malformation with variable presentation that remains a difficult reconstructive challenge. Previous reviews have concentrated on surgical technique, and data on long-term outcome are scarce. We evaluate long-term outcome and when possible correlate outcome with anatomy at presentation. The records and radiographs of 64 patients 0.5 to 25 years old with persistent cloaca treated at 1 institution from 1975 to 2000 were retrospectively reviewed to determine the outcome for urinary and fecal continence. Outcome data were available in 61 girls as 3 died. Of these patients 11 were younger than 3 years, making evaluation of continence difficult, and so the remaining 50 patients constitute the study population. Mean patient age at review was 11.3 years (range 4 to 25). Of the 50 patients 10 (20%) are incontinent of urine (4 with urinary diversion) and 40 (80%) are socially continent, including 11 (22%) who void spontaneously, 6 (12%) who perform clean intermittent catheterization alone and 23 (46%) who underwent reconstructive surgery. Fecal continence was achieved in 30 (60%) of patients and 40% are fecal incontinent or have a stoma. The majority of patients born with a cloacal malformation can achieve social fecal and urinary control, although in 46% additional reconstructive surgery was required. The presence of a good bladder neck, short common channel, a normal sacrum and 2 normal kidneys indicates improved prognosis for urinary continence. Achieving normal voiding continence in a child with a cloacal malformation still represents an enormous surgical challenge.

Carcinoma of the breast metastatic to the ureter seven years later

We present a case of ureteral metastasis from a primary breast cancer where the disease recurred with an episode of renal colic 7 years after diagnosis. A surgical operation was performed to remove the terminal ureter and the perimeatal area of the urinary bladder. Urological and radiological outcome was satisfactory after a 2-year follow up.

Upper and lower urinary tract outcome after surgical repair of cloacal malformations: a three‐decade experience

To report the urological outcome of the surgical correction of persistent cloaca, which is technically demanding and may require many procedures in an effort to preserve renal function and provide urinary continence. A retrospective chart review from 1971 to 2003 identified 23 patients with cloacal malformations (two posterior, 21 classical) that were reconstructed. The confluence of the urethra, vagina and rectum was noted to be high in 16, low in five and unknown in two; one patient was a conjoined twin. The mean (range) follow-up was 9.3 (0.4-31.6) years. Urinary anomalies included 14 patients with renal anomalies (six solitary kidneys, four renal dysplasia, two pelvi-ureteric junction, one each duplex and crossed fused) and two duplicated bladders. Vesico-ureteric reflux was present in 13 patients (57%), hydronephrosis at birth in 13, a bony vertebral abnormality in 14 and the VACTERL association in four. Total urogenital mobilization (TUM) was used in six patients and spinal cord untethering in four; a nephrectomy was required in three and partial nephrectomy in one. Upper tract dilation was still present in six patients. Age-adjusted creatinine levels were abnormal in four (18%) patients and borderline in another six (26%). In the nine patients with a solitary kidney (six solitary, three after nephrectomy), the age-adjusted creatinine level was abnormal in two and borderline in four. A vesicostomy was initially performed in 11 patients. The method of bladder emptying is known in 22; 10 void, 11 require clean intermittent catheterization (five abdominal stoma, six urethral) and one was diverted with a conduit. Of the 18 patients aged > 47 months 15 were continent (14 complete > 4 h, one partial 2-4 h), and three are wet (one conduit). Reconstruction of the lower urinary tract included four bladder augmentations (one ureteric, one ileal, two colon), five bladder neck procedures (two artificial sphincter, one each bladder neck repair, sling, bladder neck division) and six catheterizable channels (one now with a colon conduit). The ureters were re-implanted in 12 patients. Although the surgical correction of this rare malformation is complex, the upper urinary and lower urinary tract outcome can be favourable, albeit after several reconstructive procedures. TUM has emerged as the primary method for vaginal reconstruction, but the long-term lower tract outcome after this procedure is awaited.

Limitations of Using Outcomes in the Placebo Arm of a Clinical Trial of Benign Prostatic Hyperplasia to Quantify Those in the Community

OBJECTIVES To quantify potential biases that may occur when placebo arms of clinical trials are used to characterize the natural history of disease and to compare incidence rates of benign prostatic hyperplasia (BPH) outcomes in community-dwelling men with outcomes in the placebo arm of a clinical trial of BPH. SUBJECTS AND METHODS White men aged 50 years or older at baseline were selected randomly from the Olmsted County, Minnesota, community in 1990 and were monitored biennially through 1996 for urologic outcomes. Symptom progression, acute urinary retention, and minimally invasive or surgical treatment of BPH were assessed from a validated questionnaire and a review of community medical records. Findings from the Olmsted County Study (N=1193) and a selected subcohort (n=238) were compared with those from the placebo arm of the Medical Therapy of Prostatic Symptoms trial (N=737). RESULTS During more than 5088 person-years of follow-up (mean, 4.9 years) in the Olmsted County Study, incidence rates per 1000 person-years were 8.5 (95% confidence interval [CI], 6.4-11.2) for acute urinary retention, 97.1 (95% CI, 88.7-106.0) for symptom progression, 6.6 (95% CI, 4.8-9.0) for surgery or minimally invasive treatment, and 105.1 (95% CI, 96.4-114.4) for any outcomes for all men. For those meeting trial inclusion criteria (selected subcohort, n=238), incidence rates were 18.3, 86.5, 16.8, and 109.4, respectively. By comparison, incidence rates per 1000 person-years for the placebo arm of the Medical Therapy of Prostatic Symptoms clinical trial for BPH (mean follow-up, 4.5 years) were 6 for acute urinary retention, 36 for symptom progression, and 45 for any outcome, but the estimate of 13 for surgery or minimally invasive treatment was higher than for men in the Olmsted County Study. CONCLUSIONS Compared with community-dwelling men, men in the placebo arm of this clinical trial of BPH treatments had a substantially lower risk of BPH-related outcomes. Extrapolation of findings from the placebo arm of clinical trials to describe the natural history of disease in community-dwelling men should be done with caution and appropriate recognition of limitations. To quantify potential biases that may occur when placebo arms of clinical trials are used to characterize the natural history of disease and to compare incidence rates of benign prostatic hyperplasia (BPH) outcomes in community-dwelling men with outcomes in the placebo arm of a clinical trial of BPH. White men aged 50 years or older at baseline were selected randomly from the Olmsted County, Minnesota, community in 1990 and were monitored biennially through 1996 for urologic outcomes. Symptom progression, acute urinary retention, and minimally invasive or surgical treatment of BPH were assessed from a validated questionnaire and a review of community medical records. Findings from the Olmsted County Study (N=1193) and a selected subcohort (n=238) were compared with those from the placebo arm of the Medical Therapy of Prostatic Symptoms trial (N=737). During more than 5088 person-years of follow-up (mean, 4.9 years) in the Olmsted County Study, incidence rates per 1000 person-years were 8.5 (95% confidence interval [CI], 6.4-11.2) for acute urinary retention, 97.1 (95% CI, 88.7-106.0) for symptom progression, 6.6 (95% CI, 4.8-9.0) for surgery or minimally invasive treatment, and 105.1 (95% CI, 96.4-114.4) for any outcomes for all men. For those meeting trial inclusion criteria (selected subcohort, n=238), incidence rates were 18.3, 86.5, 16.8, and 109.4, respectively. By comparison, incidence rates per 1000 person-years for the placebo arm of the Medical Therapy of Prostatic Symptoms clinical trial for BPH (mean follow-up, 4.5 years) were 6 for acute urinary retention, 36 for symptom progression, and 45 for any outcome, but the estimate of 13 for surgery or minimally invasive treatment was higher than for men in the Olmsted County Study. Compared with community-dwelling men, men in the placebo arm of this clinical trial of BPH treatments had a substantially lower risk of BPH-related outcomes. Extrapolation of findings from the placebo arm of clinical trials to describe the natural history of disease in community-dwelling men should be done with caution and appropriate recognition of limitations.

Limitations of Using Outcomes in the Placebo Arm of a Clinical Trial of Benign Prostatic Hyperplasia to Quantify Those in the Community

To quantify potential biases that may occur when placebo arms of clinical trials are used to characterize the natural history of disease and to compare incidence rates of benign prostatic hyperplasia (BPH) outcomes in community-dwelling men with outcomes in the placebo arm of a clinical trial of BPH. White men aged 50 years or older at baseline were selected randomly from the Olmsted County, Minnesota, community in 1990 and were monitored biennially through 1996 for urologic outcomes. Symptom progression, acute urinary retention, and minimally Invasive or surgical treatment of BPH were assessed from a validated questionnaire and a review of community medical records. Findings from the Olmsted County Study (N=1193) and a selected subcohort (n=238) were compared with those from the placebo arm of the Medical Therapy of Prostatic Symptoms trial (N=737). During more than 5088 person-years of follow-up (mean, 4.9 years) In the Olmsted County Study, Incidence rates per 1000 person-years were 8.5 (95% confidence Interval [CI], 6.4-11.2) for acute urinary retention, 97.1 (95% CI, 88.7-106.0) for symptom progression, 6.6 (95% CI, 4.8-9.0) for surgery or minimally invasive treatment, and 105.1 (95% CI, 96.4-114.4) for any outcomes for all men. For those meeting trial Inclusion criteria (selected subcohort, n=238), Incidence rates were 18.3, 86.5, 16.8, and 109.4, respectively. By comparison, Incidence rates per 1000 person-years for the placebo arm of the Medical Therapy of Prostatic Symptoms clinical trial for BPH (mean follow-up, 4.5 years) were 6 for acute urinary retention, 36 for symptom progression, and 45 for any outcome, but the estimate of 13 for surgery or minimally invasive treatment was higher than for men in the Olmsted County Study. Compared with community-dwelling men, men in the placebo arm of this clinical trial of BPH treatments had a substantially lower risk of BPH-related outcomes. Extrapolation of findings from the placebo arm of clinical trials to describe the natural history of disease in community-dwelling men should be done with caution and appropriate recognition of limitations.

289: Long Term Urologic Outcomes of Adult Patients with Classic and Cloacal Exstrophy and Epispadias: A Review of 50 Patients

You have accessJournal of UrologyModerated Poster, Sunday, May 22, 2005 8:00 - 10:00 am1 Apr 2005289: Long Term Urologic Outcomes of Adult Patients with Classic and Cloacal Exstrophy and Epispadias: A Review of 50 Patients Frank Papanikolaou, Richard Baverstock, Sender Herschorn, Ron Kodama, Tony Khoury, and Joao L. Pippi-Salle Frank PapanikolaouFrank Papanikolaou More articles by this author , Richard BaverstockRichard Baverstock More articles by this author , Sender HerschornSender Herschorn More articles by this author , Ron KodamaRon Kodama More articles by this author , Tony KhouryTony Khoury More articles by this author , and Joao L. Pippi-SalleJoao L. Pippi-Salle More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(18)34554-3AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "289: Long Term Urologic Outcomes of Adult Patients with Classic and Cloacal Exstrophy and Epispadias: A Review of 50 Patients." The Journal of Urology, 173(4S), p. 80 © 2016 by American Urological AssociationFiguresReferencesRelatedDetails Volume 173Issue 4SApril 2005Page: 80 Advertisement Copyright & Permissions© 2016 by American Urological AssociationMetricsAuthor Information Frank Papanikolaou More articles by this author Richard Baverstock More articles by this author Sender Herschorn More articles by this author Ron Kodama More articles by this author Tony Khoury More articles by this author Joao L. Pippi-Salle More articles by this author Expand All Advertisement Loading ...