Validity and reliability of the patient's perception of intensity of urgency scale in overactive bladder

Study Type – Prognosis (outcomes research)
Level of Evidence 2c What’s known on the subject? and What does the study add? Improvement in urinary urgency is an important goal for patients with overactive bladder, and should be measured along with change in other key symptoms in overactive bladder clinical trials. Existing scales that measure urinary urgency during completion of a bladder diary have incomplete evidence of validity. Used as part of a 3‐day bladder diary the Patient’s Perception of Intensity of Urgency Scale has good test‐retest reliability and responsiveness. It correlates with other measures of condition severity, and distinguishes well between patient groups. The scale should therefore be useful both in clinical practice and in research.

OBJECTIVE

• ? To assess the measurement characteristics of the Patient Perception of Intensity of Urgency Scale (PPIUS) in patients with overactive bladder (OAB).

PATIENTS AND METHODS

• ? Adult women with at least a 3‐month history of OAB. The design was a 4‐week, double‐blind, randomized, placebo‐controlled trial of transdermal oxybutynin, with a 2‐week placebo run‐in and 8‐week, open‐label extension.
• ? Symptom improvement was assessed using 3‐day bladder diaries incorporating the PPIUS, and disease‐specific health‐related quality of life was assessed using the King’s Health Questionnaire (KHQ). Convergent validity was shown by correlation with the KHQ, and other bladder diary variables. Known groups validity was assessed by comparison of baseline mean urge ratings, and urgency episode frequency for continent and incontinent patients, and by comparison with the same measures from a historical control group of 40 asymptomatic female volunteers.
• ? Between‐ and within‐groups responsiveness was assessed using standardized effect sizes (Cohen’s d and effect size r). Reliability was assessed for the two arms of the trial at different time points and intervals, using intraclass correlation (ICC) and a t‐test for the difference between mean scores.

RESULTS

• ? In total, 96 women were randomized. Urgency episode frequency showed moderate correlation with total KHQ score (r= 0.500, P < 0.001) and with daytime and night‐time voiding frequency.
• ? There were significant differences in continent and incontinent subgroups for mean urge ratings (difference in means, ?0.61/void, P < 0.001), and urgency episodes (difference in means, ?2.67 episodes/day, P < 0.001), as well as between OAB patients and normal controls (mean urge rating: difference in means 1.22 per void, P < 0.001; urgency episodes: difference in means 2.93 episodes/day, P < 0.001).
• ? Between‐groups analysis of effect size found that urgency episode frequency (d= 0.679, r= 0.321) was more responsive than mean urge rating (d= 0.480, r= 0.233). In both subgroups, urgency episode frequency (d= 0.421–0.454, r= 0.206–0.222) had better within‐groups responsiveness than mean urge rating.
• ? Urgency episodes (ICC, 0.65–0.81) were measured more reliably than urgency urinary incontinence episodes (ICC, 0.50–0.65).

CONCLUSIONS

• ? Assessment of urgency episodes using the PPIUS shows good reliability, excellent known groups validity, high responsiveness and convergence with subjective measures of severity.
• ? PPIUS is freely available, and should be useful in both clinical practice and research studies when assessing women with urgency, with or without urgency urinary incontinence.

     

Prevalence of hesitancy in 30-80-year-old Finnish men: Tampere Ageing Male Urological Study (TAMUS)

Study Type – Therapy (symptom prevalence) Level of Evidence 2a What's known on the subject? and What does the study add? In several population‐based studies the prevalence of hesitancy has varied from 20% to 52%. Studies concern mostly older men ≥50‐years‐old. Knowledge of troublesomeness that hesitancy causes is very scarce. This is a large population‐based study on hesitancy in men with a wide age range. This study reports the prevalence of hesitancy from 30‐year‐old men to 80‐year‐old men. The bother of hesitancy is reported and this is also presented in different age groups.

OBJECTIVE

• ? To estimate the prevalence and bother of hesitancy by age group.

MATERIALS AND METHODS

• ? In this population‐based study, the target population was 30‐ to 80‐year‐old men from Pirkanmaa County, Finland.
• ? Information was collected by means of a mailed self‐administered questionnaire in 2004. The overall participation proportion was 58.7% (4384 men out of 7470).
• ? The Danish Prostatic Symptom Score (DAN‐PSS‐1) questionnaire was used to evaluate urinary symptoms, particularly hesitancy. Logistic regression was used for multivariate analysis.

RESULTS

• ? Almost half of the men (46.8%, 95% CI 45.3–48.3%) reported hesitancy at least occasionally, but only 0.5% (95% CI 0.3–0.7%) had hesitancy every time they urinated. The prevalence of any hesitancy was 42.3% at 30 years and 50.5% at 80 years of age (trend P < 0.001). Only a few men reported hesitancy often or always, prevalence increasing with age from 2.6% to 11.4% (trend P < 0.001).
• ? Hesitancy caused a small problem for 18.3% of the men and a moderate or major problem for 0.9–5.3%. Only 3% of the men with infrequent hesitancy reported more than a small problem, whereas 59% of the men with hesitancy often or always reported a small problem and 32% reported a moderate or major problem.
• ? Two other voiding symptoms, straining and weak stream, were strongly associated with hesitancy (with odds ratios exceeding 80).

CONCLUSIONS

• ? Mild hesitancy is very common in men of all ages.
• ? Severe cases are rare, but the prevalence increases with age.
• ? Hesitancy is a well‐tolerated urinary symptom.

     

The effect of surgical intervention for stress urinary incontinence (UI) on post-prostatectomy UI during sexual activity

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? It is well recognized that RP is associated with short‐ and long‐term SUI and erectile dysfunction. The incidence, clinical significance and treatment of UI during sexual activity is less well understood. The present study demonstrates the effectiveness of both an AUS and male sling to improve sexual QOL in men presenting with both SUI and UI during sexual activity.

OBJECTIVE

• ? To determine the impact of anti‐incontinence surgical procedures (artificial urinary sphincter [AUS] or male sling) on bother due to urinary incontinence (UI) during sexual activity after radical prostatectomy (RP).

PATIENTS AND METHODS

• ? Between October 2000 and December 2007, 27 men in a large single‐surgeon RP series underwent anti‐incontinence surgery with an AUS or male sling.
• ? In all, 16 of these 27 men completed a questionnaire retrospectively capturing bother attributable to UI during arousal and orgasm and the impact of the AUS/male sling on UI and sexual quality of life (QoL).

RESULTS

• ? In all, 15 men were evaluable. Of these, 11 were sexually active; four and seven men underwent AUS and sling placement, respectively.
• ? All 11 men had a marked improvement in stress UI symptoms, which was the primary indication for surgery.
• ? All men undergoing AUS had an improvement in their sexual QoL, and most (three of four men) indicated marked improvement.
• ? Slightly more than half of men undergoing the sling procedure reported marked improvement in sexual QoL.

CONCLUSIONS

• ? Our study shows a beneficial effect of anti‐incontinence surgery on UI during sexual activity.
• ? Whether these surgical approaches would benefit men with significant bother due to UI limited to sexual activity warrants further investigation.

     

Lower urinary tract symptoms and urinary incontinence in a geriatric cohort – a population‐based analysis

Study Type – Symptom prevalence (prospective cohort) Level of Evidence 1b What's known on the subject? and What does the study add? Prevalence and severity of urinary incontinence and lower urinary tract symptoms increase with age and have a considerable negative influence on quality of life. As a result of demographic changes the proportion of octogenarians will increase in the next decades substantially, yet the literature on urinary incontinence and lower urinary tract symptoms of the oldest old is scant. This population‐based study of 85‐year‐old subjects sheds new light on this topic.

OBJECTIVES

• ? To assess prevalence and severity of lower urinary tract function in 85‐year‐old men and women.
• ? Little is known on the prevalence of lower urinary tract dysfunction in this geriatric age group, which is now the fastest growing sector of the population worldwide.

PATIENTS AND METHODS

• ? The Vienna Trans‐Danube Aging study (VITA) is a longitudinal, population‐based study initiated in 2000 that included men/women aged 75 years living in a well‐defined area in Vienna.
• ? The main purpose of the VITA study was to identify risk factors for incident Alzheimer's disease.
• ? All study participants alive in 2010 were contacted by mail to complete a detailed questionnaire on various aspects of lower urinary tract symptoms (LUTS) and urinary incontinence (UI).

RESULTS

• ? The response rate was 68%, resulting in a total of 262 questionnaires available for analysis (men n= 96; women n= 166). All study participants were 85 years of age.
• ? Urinary incontinence defined as any involuntary loss during the past 4 weeks was reported by 24% of men and 35% of women (P= 0.04). Stress UI was more frequent in women (39%) than in men (14%, P < 0.01), the difference for urge UI (women 35%, men 25%) was on the border of statistical significance (P= 0.05). Only four individuals (1.5%) needed permanent catheterization.
• ? Urgency (women 56%, men 54%) and daytime frequency (women 70%, men 74%) were equally distributed (P > 0.05). Nocturia more often than twice was more prevalent in men (69%) than in women (49%) (P= 0.02). Overactive bladder, according to International Continence Society criteria, was present in 55% of women and 50% of men.
• ? No difference regarding quality of life impairment as the result of LUTS and UI was noticed between sexes. A few co‐morbidities were identified to correlate with UI and storage symptoms.

CONCLUSIONS

• ? These data provide insights into the prevalence and severity of LUTS and UI in individuals in their eighties, to our knowledge the largest population‐based study in this age group.
• ? Demographic changes in upcoming decades underline the importance of a thorough understanding of lower urinary tract dysfunction in a geriatric population.

     

Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial

Study Type – Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Peri‐operative pelvic floor muscle training reduces urinary incontinence for men undergoing radical prostatectomy (RP). A preoperative biofeedback session, combined with postoperative pelvic floor muscle training, and assisted sessions on a monthly basis only, is an effective low‐intensity programme to improve recovery of continence in patients undergoing RP.

OBJECTIVE

• ? To evaluate the efficacy of preoperative biofeedback (BFB) combined with an assisted low‐intensity programme of postoperative perineal physiokinesitherapy in reducing the incidence, duration and severity of urinary incontinence (UI) in patients undergoing radical prostatectomy (RP).

PATIENTS AND METHODS

• ? A prospective, single‐centre, randomized controlled clinical study was designed.
• ? The intervention group received a training session with BFB, supervised oral and written instructions on Kegel exercises and a structured programme of postoperative exercises on the day before open RP. After RP, patients received control visits, including a session of BFB, at monthly intervals only.
• ? The control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home. Patients received control visits at 1, 3 and 6 months after catheter removal.
• ? At each visit the number of incontinence episodes, the number of pads used and patient‐reported outcome measures (International Consultation on Incontinence Questionnaire on Urinary Incontinence [ICIQ‐UI], [ICIQ]‐Overactive Bladder [OAB], University of California, Los Angeles‐Prostate Cancer Index [UCLA‐PCI], International Prostate Symptom Score‐Quality of Life [IPSS‐QoL]) were assessed in both groups. All patients were followed‐up for a period of at least 6 months after catheter removal.
• ? The primary outcome was the recovery of continence, strictly defined as a ICIQ‐UI score of zero.

RESULTS

• ? Overall, 34 consecutive patients were eligible and 32 were available for the final analysis: 16 patients for each study group. The two groups were homogeneous for all pre‐ and intraoperative features examined.
• ? In the intervention group, continence had been achieved by six, eight and 10 patients at 1‐, 3‐ and 6‐month follow‐ups, respectively, vs no patients (P= 0.02), one patient (P= 0.01) and one patient (P= 0.002) in the control group at each follow‐up, respectively.
• ? The analysis of the UCLA‐PCI and ICIQ‐OAB scores, the number of incontinence episodes per week and the number of pads per week showed significant differences in favour of patients in the intervention group at 3 and 6 months.
• ? Patients in the intervention group reported better IPSS‐QoL scores at all follow‐up times but the difference did not reach statistical significance.

CONCLUSIONS

• ? Preoperative BFB combined with a postoperative programme of perineal physiokinesitherapy and assisted sessions on a monthly basis only, is a treatment strategy significantly more effective than the standard care in improving recovery of continence in patients undergoing RP.
• ? The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.

     

Effectiveness of medical and surgical therapies for lower urinary tract symptoms in the community setting

Study Type – Therapy (outcomes research) Level of Evidence 2c What's known on the subject? and What does the study add? It is known that benign prostatic hyperplasia is a common condition affecting most men by the age of 80 years. There are multiple treatment options available, including both medical and surgical interventions. However, what is not known is how affective the different types of interventions are in the general population. Previous studies have focused on centre‐specific data. What is unique about our study is that it is a prospective cross‐section analysis of a community cohort of men. Through this study we were able to assess the outcomes in the general population as opposed to in a high‐volume surgical centre. Our findings show that in this community medical management was poor at symptomatic improvement, whereas surgical intervention produced the best improvement.

OBJECTIVE

• ? To describe the use and symptomatic outcomes of different therapies for lower urinary tract symptoms (LUTS) in a community‐based population of men followed for 17 years.

PATIENTS AND METHODS

• ? Data from a randomly selected cohort of 2184 men, aged 40–79 years in 1990, from Olmsted County, Minnesota, USA were included in the study. Participants completed a questionnaire similar to the American Urological Association Symptom Index (AUASI) and reported on incontinence.
• ? Men were followed biennially through 2007 (median follow‐up: 13.7 years; Q1, Q3: 8.8, 15.7). Medical and surgical treatments for LUTS were reported on biennial questionnaires and abstracted from community medical records.

RESULTS

• ? Overall, 610 (28%) men received medical or surgical therapy for treatment of LUTS. Patients undergoing vaporization and transurethral resection of the prostate (TURP) had the highest pre‐intervention AUASI scores (P < 0.001) and the most rapid increase in scores over time (P= 0.002) compared with those treated with medications or no therapy. After intervention, symptom progression slowed in all treatment groups.
• ? However, the greatest improvement in AUASI score (median % change) was observed in the TURP group: ?27.45%. The TURP group also reported a significant decrease in incontinence after surgery (% change): TURP: ?22.58%.

CONCLUSION

• ? All therapies were effective at slowing the progression of LUTS, but only TURP patients reported a significant decrease in both LUTS and incontinence after therapy.

     

A comparative performance analysis of total prostate-specific antigen, percentage free prostate-specific antigen, prostate-specific antigen velocity and urinary prostate cancer gene 3 in the first, second and third repeat prostate biopsy

Study Type – Diagnostic (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Although non‐recommended PSA testing has been reported in men younger than 40 years of age, there are few recognized data on PSA in younger American men, particularly younger African‐American men, to provide age‐ and race‐specific references. Using data from an existing large study of young, male members of the US military, aged 28–36 years, the present study provides PSA reference distributions for young Caucasian‐American men (median = 0.56, 95th percentile = 1.42, range: <0.01–3.34 ng/mL) and African‐American men (median = 0.64, 95th percentile = 1.89, range: 0.12–6.45 ng/mL). Previous estimates from the literature are also summarized.

OBJECTIVE

• ? To provide race‐specific prostate‐specific antigen (PSA) reference distributions for young men less than 40 years of age who might have undergone non‐recommended PSA testing because of their family history of prostate cancer or inadvertently as part of a standard panel of tests.

MATERIALS AND METHODS

• ? We used data from a large existing study of young, male Caucasian‐ and African‐American members of the US military with stored serum in the Department of Defense serum repository.
• ? As part of this previous study, we selected a random sample of 373 Caucasian‐ and 366 African‐American men aged 28–36 years with an archived serum specimen collected for standard military purposes from 2004 to 2006.
• ? We measured serum total PSA concentration in this specimen using the Beckman Coulter Access Hybritech PSA assay.

RESULTS

• ? The PSA level ranged from <0.01 to 3.34 ng/mL among Caucasian‐American men, with a median of 0.56 ng/mL and a 95th percentile of 1.42 ng/mL.
• ? The PSA level ranged from 0.12 to 6.45 ng/mL among African‐American men, with a median of 0.64 ng/mL and 95th percentile of 1.89 ng/mL.
• ? The PSA level was significantly higher in African‐ than in Caucasian‐American men (P= 0.001).

CONCLUSION

• ? The PSA estimates, together with those summarized from the literature, provide age‐ and race‐specific PSA reference distributions for young men who might have undergone non‐recommended PSA testing.
• ? Comparisons by race could also begin to inform the timing of divergence of prostate cancer risk by race.

     

The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study

Study Type – Therapy (RCT)
Level of Evidence 1b What’s known on the subject? and What does the study add? Long‐term treatment with combination therapy (dutasteride plus tamsulosin) is significantly superior to tamsulosin but not dutasteride at reducing the relative risk of AUR or BPH‐related surgery. Furthermore, combination therapy is significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression, and provides significantly greater reductions in IPSS. In addition, combination therapy significantly improves patient‐reported, disease specific QoL and treatment satisfaction compared with either monotherapy. Two‐year results from the CombAT study showed that combination therapy was more effective than either monotherapy in controlling both storage and voiding symptoms, irrespective of baseline prostate volume (for men with prostate volume ≥30 cc). This post‐hoc two‐year analysis also showed that treatment with dutasteride not only improved voiding symptoms, as would be expected from its effects on prostate volume, but was also as effective as the α‐blocker tamsulosin in the control of storage symptoms.

OBJECTIVE

• ? To assess the effects of combined therapy with dutasteride and tamsulosin on voiding and storage symptoms compared with those of dutasteride or tamsulosin alone, using 4‐year data from the Combination of Avodart and Tamsulosin (CombAT) study.

PATIENTS AND METHODS

• ? Men (n = 4844) aged ≥50 years with moderate‐to‐severe lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH), a prostate volume of ≥30 mL, and a serum prostate‐specific antigen level of 1.5–10 ng/mL.
• ? CombAT was a multicentre, double‐blind, parallel‐group study.
• ? Oral dutasteride (0.5 mg) or tamsulosin (0.4 mg) alone or in combination was taken daily for 4 years.
• ? Mean changes from baseline in storage and voiding symptoms at 4 years were assessed using subscales of the International Prostate Symptom Score.

RESULTS

• ? At 4 years, the mean reduction in the storage subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference ?0.43) and tamsulosin (adjusted mean difference ?0.96) monotherapy groups (P < 0.001).
• ? Also at 4 years, the mean reduction in the voiding subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference ?0.51) and tamsulosin (adjusted mean difference ?1.60) monotherapy groups (P < 0.001).
• ? The improvement in the storage subscore with combined therapy was significantly better (P < 0.001) than dutasteride and tamsulosin from 3 months and 12 months, respectively. Similarly, the improvement in the voiding subscore with combined therapy was significantly better than dutasteride (P < 0.001) and tamsulosin (P ≤ 0.006) from 3 months and 6 months, respectively.
• ? Improvements in the storage and voiding symptom subscores with combined therapy were achieved irrespective of prostate volume, although in men with the highest baseline prostate volumes (≥58 mL), combined therapy was not better than dutasteride.

CONCLUSIONS

• ? In men with a prostate volume of ≥30 mL, combined therapy with dutasteride plus tamsulosin provided better long‐term (up to 4 years) control of both storage and voiding LUTS compared with tamsulosin monotherapy.
• ? Combined therapy was better than dutasteride monotherapy in men with prostate volumes of ≥30 to <58 mL, but not in men with a prostate volume of ≥58 mL.

     

Sustained improvement in patient-reported outcomes during long-term fesoterodine treatment for overactive bladder symptoms: pooled analysis of two open-label extension studies

Study Type – Outcomes (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Short‐term (12‐week) trials have demonstrated that subjects with OAB who receive treatment with fesoterodine 4‐ and 8‐mg, either in fixed‐dose or flexible‐dose regimens, show significant improvements in measures of HRQL and other patient‐reported outcomes. The results of this long‐term, open‐label study show that treatment with fesoterodine for up to 24 months resulted in sustained improvement in measures of HRQL and severity of bladder‐related problems in subjects with OAB symptoms. Throughout the study, a high percentage of subjects reported satisfaction with fesoterodine treatment. The results were similar in men and women and across age groups (<45 years; 45–64 years; 65–74; ≥75 years). Long term treatment with fesoterodine is beneficial to patients with overactive bladder.

OBJECTIVES

• ? To evaluate the effects of long‐term fesoterodine treatment on health‐related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms.
• ? To determine the impact of gender and age on these effects.

PATIENTS AND METHODS

• ? This is a post hoc analysis of data pooled from identically designed open‐label extensions of two randomized, double‐blind, 12‐week fesoterodine studies.
• ? Initial treatment was once‐daily fesoterodine 8 mg; subjects had the opportunity to receive open‐label fesoterodine for ≥24 months.
• ? After 1 month, subjects could elect dose reduction to 4 mg and subsequent re‐escalation to 8 mg; dose reduction and re‐escalation were each allowed once annually.
• ? Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire–Short Form (ICIQ‐SF) and a Likert scale evaluating severity of bladder‐related problems were assessed at open‐label baseline and months 12 and 24; treatment satisfaction was assessed at open‐label baseline and at months 4, 12 and 24.

RESULTS

• ? A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged <45 years, n= 134; 45–64 years, n= 432; 65–74 years, n= 204; ≥75 years, n= 94); most subjects (77%) who continued treatment maintained the 8‐mg dose.
• ? Among subjects in the overall population, there were significant improvements in all KHQ domains, ICIQ‐SF scores, and bladder‐related problems at open‐label baseline vs double‐blind baseline (P < 0.05); additional significant improvements were observed at months 12 and 24 vs open‐label baseline in all outcomes (P < 0.05) except for the KHQ General Health Perception domain.
• ? When data were stratified by gender or age, significant improvements at open‐label baseline vs double‐blind baseline were further significantly enhanced or sustained at months 12 and 24 for most KHQ domains, and for ICIQ‐SF scores and bladder‐related problems for all groups. Women had significantly greater improvements than men in the KHQ Emotion (P= 0.0173) and Severity/Coping (P= 0.0112) domains and ICIQ‐SF scores (P= 0.0276) during open‐label treatment. Subjects aged <45 years had significantly greater improvement in the Personal Relationships domain compared with those aged 45–64 years (P= 0.0357) and in the Sleep/Energy domain compared with all other groups (all P < 0.02).
• ? Treatment satisfaction was high (≥92%) throughout open‐label treatment regardless of gender or age.

CONCLUSIONS

• ? Long‐term fesoterodine treatment was associated with sustained improvement in measures of health‐related quality of life and bladder‐related problems and with high treatment satisfaction in subjects with overactive bladder symptoms.
• ? Effects of gender and age were minimal.

     

Photoselective vaporization of the prostate using the 120-W lithium triborate laser in enlarged prostates (>120 cc)

Study Type – Therapy (case series) Level of Evidence 4 OBJECTIVE

• ? To evaluate experience with high power LBO laser for large prostates

PATIENTS AND METHODS

• ? Prospective database of 288 men treated with PVP from November 2006–2009
• ? 33 men identified to have transrectal ultrasound measured prostate size >120 cc
• ? All but 9 men not in urinary retention or on anticoagulant medications
• ? Average ASA Score 2.25 (range 1–4) with 11 having an ASA Score of 3 or more

RESULTS

• ? Mean operating time and laser time 109 and 86 minutes respectively
• ? IPSS, QoL and Qmax changes from baseline to 3 months for those not in retention were 24 to 8.6, 5.0 to 1.8 and 7.5 mL/s to 19.6 mL/s respectively
• ? Post void residual in these men fell from a mean of 235 mL to 88 mL
• ? Average fall in PSA was 38% for 22 men with paired PSA data
• ? Post operative urinary retention in 4 men resolved. 2 late onset clot urinary retention

CONCLUSION

• ? Early results demonstrate PVP to be safe and efficacious on early follow up in a high risk group of patients with significantly enlarged prostates, anticoagulation and urinary retention

     

Is joint hypermobility associated with vesico‐ureteral reflux? An assessment of 50 patients

Study Type – Aetiology (individual cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Recent studies have already shown associations between generalized joint hypermobility (GJH) and voiding and defecation dysfunction and/or slow transit constipation. Changes in extracellular matrix composition in vesico‐ureteric junction of vesico‐ureteral reflux (VUR) patients were also observed previously. This study is the first to assess joint mobility as a parameter for connective tissue composition in vesico‐ureteral reflux. We convincingly demonstrate that VUR patients have significantly more hypermobile joints compared to controls and this provides a new angle to the intriguing subjects of development of VUR and susceptibility to VUR.

OBJECTIVE

• ? To assess whether there is an increased prevalence of joint hypermobility in patients with vesico‐ureteric reflux (VUR).

MATERIALS AND METHODS

• ? We studied 50 patients with primary VUR and matched controls drawn from a reference population.
• ? Joint mobility was assessed using the Bulbena hypermobility score.

RESULTS

• ? We identified significantly more patients with VUR with generalized joint hypermobility than controls (24% vs 6.7%, P= 0.007).

CONCLUSION

• ? Our findings confirm our clinical observation of an increased rate of joint hypermobility in patients with VUR. We speculate that an altered composition of the connective tissue may contribute to the severity of the (pre‐existing) VUR phenotype.

     

Microstructure and cytocompatibility of collagen matrices for urological tissue engineering

What's known on the subject? and What does the study add? The gold standard in the reconstruction of the defect urinary system is still the transplantation of autologous gastrointestinal segments although numerous different types of biomaterials (natural/synthetic) have been investigated as possible replacements. However, the ideal biomaterial is still not identified. In this study, we were able to identify the engineered collagen‐based OptiMaix® scaffolds as promising biomaterials for the reconstruction of the urinary tract.

OBJECTIVES

• ? To analyse the in vitro cytocompatibility of several engineered collagen‐based biomaterials for tissue engineering of the urinary tract.
• ? Tissue‐engineered implants for the reconstruction of the urinary tract are of major interest for urological researchers as well as clinicians. Although several materials have been investigated, the ideal replacement has still to be identified.

MATERIALS AND METHODS

• ? Several collagen matrices were tested.
• ? Electron microscopy was used to visualize the microstructure of the tested matrices.
• ? Examination of cell attachment and growth of primary porcine urothelial and smooth muscle cells were performed and cell phenotypes were analysed using immunohistochemical stains.
• ? Urea permeability was investigated using Ussing chamber experiments.

RESULTS

• ? The best cytocompatibility for both urinary tract‐specific cell types was obtained with OptiMaix® (Matricel GmbH, Herzogenrath, Germany) materials.
• ? Cell‐specific phenotypes were maintained during culture as shown by immunohistochemical staining.
• ? Furthermore, simultaneous cultivation of both cell types for 7 and 14 days significantly reduced urea permeability.

CONCLUSION

• ? These results show the potential of OptiMaix materials in tissue engineering approaches of urinary tract tissues.

     

The absence of voiding symptoms in men with a prostate-specific antigen (PSA) concentration of ≥3.0 ng/mL is an independent risk factor for prostate cancer: results from the Gothenburg Randomized Screening Trial

Study Type – Prognostic (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? There are only a few studies and no consensus concerning the relationship between LUTS and prostate cancer. This paper focuses on 2353 men with an elevated PSA level within the Gothenburg Randomized Screening Trial who underwent biopsy and answered questions regarding LUTS. The main conclusion was that the absence of voiding symptoms is an independent risk factor for prostate cancer detection.

OBJECTIVE

• ? To investigate whether men with obstructive voiding symptoms are at increased risk for being diagnosed with prostate cancer within the Gothenburg randomized population‐based prostate cancer screening trial.

SUBJECTS AND METHODS

• ? In 1995, 20 000 men born between 1930 and 1944 were randomly selected from the population register and randomized to either a screening group (10 000), invited for total prostate‐specific antigen (tPSA) testing every second year until they reached an upper age‐limit pending between 67 and 71 years, or to a control group not invited (10 000).
• ? Men with a PSA concentration of ≥3.0 ng/mL were offered further examination with prostate biopsies. Immediately before the physician's examination a self‐administered, study‐specific questionnaire was completed including one question concerning obstructive voiding symptoms.
• ? Multivariate logistic regression modelling was used to estimate odds ratios (ORs) for associations of age, tPSA, free/total PSA (f/tPSA) ratio, prostate volume and the presence of voiding symptoms in prostate cancer risk. A P < 0.05 was considered statistically significant.

RESULTS

• ? Between 1995 and 2010 there were 2590 men who had an elevated PSA concentration (≥3.0 ng/mL) at least once during the study. Of these, 2353 men (91%) accepted further clinical examination with transrectal ultrasonography (TRUS) and prostate biopsies. In all, 633/2353 men had prostate cancer (27%) on biopsy and 1720/2353 men (73%) had a benign pathology.
• ? Men with prostate cancer reported a lower frequency of voiding symptoms (24% vs 31%, P < 0.001), independent of age and locally advanced tumours (T2b–T4). In the multivariate logistic regression model increasing age and tPSA were positively associated with prostate cancer while prostate volume, f/tPSA ratio and the presence of voiding symptoms were all inversely associated with the risk of detecting prostate cancer in a screening setting. This inverse association of voiding symptoms and prostate cancer detection was restricted to men with large prostates (>37.8 mL); 15% in men with voiding symptoms vs 22% in asymptomatic men (P < 0.001).

CONCLUSION

• ? The presence of voiding symptoms should not be a decision tool for deciding which men with an elevated PSA concentration should be offered biopsies of the prostate.

     

Androgen deprivation therapy for volume reduction,lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide

Study Type – Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Androgen deprivation therapy (ADT) is commonly used as a primary treatment for patients with prostate cancer (PCa) who are not eligible for radical treatment options. ADT is also used in patients with PCa as neo‐adjuvant hormone therapy to reduce prostate volume and down‐stage the disease before radiotherapy with curative intent. The present study showed that ADT with the gonadotropin hormone‐releasing hormone (GhRH) antagonist degarelix is non‐inferior to combined treatment with the LHRH agonist goserelin and bicalutamide in terms of reducing prostate volume during the treatment period of 3 months. Degarelix treatment evokes, however, significantly better relief of lower urinary tract symptoms in patients having moderate and severe voiding problems.

OBJECTIVE

• ? To assess the efficacy of monthly degarelix treatment for reduction of total prostate volume (TPV), relief of lower urinary tract symptoms (LUTS) and improvement of quality of life (QoL) in patients with prostate cancer (PCa) using monthly goserelin as active control.

METHODS

• ? This was a randomized, parallel‐arm, active‐controlled, open‐label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks.
• ? For flare protection, goserelin‐treated patients also received daily bicalutamide (50 mg) during the initial 28 days.
• ? Key trial variables monitored monthly were TPV (primary endpoint), serum testosterone, prostate‐specific antigen (PSA), the International Prostate Symptom Score (IPSS) and the Benign Prostate Hyperplasia Impact Index.

RESULTS

• ? In all, 175 patients completed the trial (96.1%).
• ? At week 12, changes in TPV for degarelix and goserelin were similar (?37.2% vs ?39.0%) and met the predefined non‐inferiority criterion.
• ? Decreases in IPSS were greater in degarelix than in goserelin‐treated patients, differences being statistically significant in patients with baseline IPSS > 13 (?6.7 ± 1.8 vs ?4.0 ± 1.0; P= 0.02).
• ? The number of patients with an IPSS change of ≥3 over baseline was also significantly higher in patients treated with degarelix (61.0 vs 44.3%, P= 0.02).
• ? Both treatments were safe and well tolerated.

CONCLUSIONS

• ? Medical castration reduces TPV and could also improve LUTS in patients with PCa.
• ? While the short‐term efficacy of degarelix and goserelin + bicalutamide was the same in terms of TPV reduction, degarelix showed superiority in LUTS relief in symptomatic patients, which could highlight the different actions of these drugs on extrapituitary gonadotrophin‐releasing hormone (GnRH) receptors in the bladder and/or the prostate.

     

Long-term toxicity and quality of life up to 10 years after low-dose rate brachytherapy for prostate cancer

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add?

• ? Prostate BXT is an established treatment option for low and intermediate risk localized prostate cancer. Long‐term studies have confirmed similar oncological outcomes for low risk disease compared with radical prostatectomy and external beam radiotherapy.
• ? This study reports long‐term toxicity for a large cohort of patients who had been followed‐up after LDR BXT for up to 10 years, with a minimum follow‐up of 5 years.
• ? Long‐term toxicity results are very encouraging and provide useful date to help clinicians and patients make informed treatment choices.

OBJECTIVE

• ? To report on the long‐term toxicity outcome for patients with prostate cancer treated by low‐dose rate (LDR) brachytherapy (BXT).

PATIENTS AND METHODS

• ? The study population comprised a cohort of men treated in our centre between March 1999 and April 2004 with LDR BXT for prostate cancer who had at least 5 years of follow‐up post‐implant.
• ? Patients who had died or experienced biochemical failure were excluded.
• ? We contacted eligible patients and asked them to complete a questionnaire to assess current urinary, erectile and bowel function.
• ? Urinary and erectile function was compared pre‐ and post‐treatment and outcomes were assessed by treatment modality.

RESULTS

• ? Of the 226 LDR BXT‐treated patients with >5 years of follow‐up, 174 (77.0%) responded to the questionnaire.
• ? The mean International Prostate Symptom Score (IPSS) increased from 6.70 pre‐BXT to 7.91 at follow‐up (P= 0.003). Of the patients with mild symptoms pre‐BXT (IPSS, 0–7), 64.2% retained mild symptoms at follow‐up, 31.2% developed moderate symptoms (IPSS, 8–9) and 4.6% reported severe symptoms (IPSS, 20–35).
• ? A good or acceptable quality of life (QoL) secondary to urinary symptoms (IPSS QoL, 0–4) was reported by 98.0% of respondents.
• ? Of those patients potent (International Index of Erectile Function‐5 ≥11) pre‐BXT, 62.9% remained potent at follow‐up. There were no differences in the proportion of patients who were potent when analyzed by the number of years post‐implant.
• ? At follow‐up, 51.7% and 45.4% of patients, respectively, had normal or mild bowel symptoms as indicated by the European Organisation for the Research and Treatment of Cancer questionnaire (QLQ‐C30/PR25 scores, 4–8). Moderate bowel symptoms (QLQ‐C30/PR25 scores, 9–12) were reported by 2.9% of respondents; none reported severe symptoms.

CONCLUSION

• ? The present study shows low morbidity after LDR BXT over the long‐term for a large cohort of patients.

     

Natural history of lower urinary tract symptoms in Japanese men from a 15-year longitudinal community-based study

Study Type – Symptom prevalence (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? There have been few longitudinal community‐based studies on LUTS suggestive of BPH. It is important to determine the natural history of LUTS suggestive of BPH among men in various countries because it is known that there are differences according to race. Although we previously reported a cross‐sectional community‐based survey on LUTS suggestive of BPH in Japanese men, no longitudinal data were available. The present study provides 15‐year longitudinal data on LUTS suggestive of BPH and related variables in Japanese men.

OBJECTIVE

• ? To report the natural history of benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in Japanese men.

PATIENTS AND METHODS

• ? From 1992 to 1993, we conducted a cross‐sectional community‐based study on LUTS suggestive of BPH in Japanese men aged 40–79 years.
• ? After 15 fifteen years, a follow‐up study was conducted to determine their longitudinal changes of LUTS.
• ? Of the 319 participants taking part in the initial study, 135 participated again in the follow‐up study.
• ? We investigated International Prostate Symptom Score (IPSS), quality of life index and bother score using a questionnaire, and measured prostate volume (PV), prostate‐specific antigen (PSA) level and peak urinary flow rate (Q_max) using a method that we have employed previously.

RESULTS

• ? The change in the total IPSS during 15 years was significant (P= 0.001) and its mean (sd ) annual change was 0.11 (0.40).
• ? Although there was little change in the bother score, a significant correlation was observed between changes in the IPSS and bother score (r= 0.528, P < 0.001).
• ? For the individual IPSS and bother scores, only changes in urgency, weak stream and nocturia were significant.
• ? The changes in PV, PSA level and Q_max were significant.
• ? The change in the total IPSS did not correlate with the changes in these variables.

CONCLUSION

• ? In a 15‐year‐longitudinal community‐based study for Japanese men, we have shown that the IPSS and quality of life index deteriorated, PV and PSA level increased, and Q_max decreased.

     

Prospective multi-centre study of adjustable single-incision mini-sling (Ajust(®) ) in the management of stress urinary incontinence in women: 1-year follow-up study

Study Type – Therapy (individual cohort) Level of Evidence 2b What's known on the subject? and What does the study add? A number of SIMS have been introduced into clinical practice in 2006 and has been so far shown to be inferior to standard mid urethral‐slings. Adjustable SIMS (Ajust) have been recently introduced into clinical practice however with little evidence on its safety and efficacy in surgical treatment of female SUI. SIMS‐Ajust^® is associated with low rates of postoperative pain and peri‐operative morbidity and is both feasible and acceptable under local anaesthesia. The patient reported success rate at 1‐year is 80%.

OBJECTIVES

• ? To determine whether an adjustable single‐incision mini‐sling (SIMS, Ajust^®) is safe and effective in the management of female stress urinary incontinence (SUI) at 12 months follow‐up.
• ? To determine whether it is feasible to be performed under local anesthesia (LA).

MATERIALS AND METHODS

• ? The present study is a multicentre prospective cohort study in which 90 female patients underwent SIMS‐Ajust^® using a standardized insertion technique.
• ? The last 45 women were offered the procedure under LA.
• ? All patients completed their 12‐month follow‐up.

RESULTS

• ? The patient‐reported success rate, using Patient Global Impression of Improvement (PGI‐I), was 80% at 12 months follow‐up and a further 6% (n= 5) reported themselves to be ‘improved’.
• ? In all, 32/45 (71%) patients agreed to undergo the procedure under LA while one patient required conversion to general anaesthetic.
• ? There was no organ damage or requirement for blood transfusion.
• ? Significantly lower rates of blood loss (P= 0.025) and postoperative voiding difficulties (P= 0.026) were seen in the LA group.
• ? The re‐operation rate for SUI was 6% at 12 months.

CONCLUSIONS

• ? SIMS (Ajust) appears to be a safe procedure, which is feasible under LA.
• ? SIMS (Ajust) have an 80% patient‐reported success rate at 12 months follow‐up.

     

A natural history of weight change in men with prostate cancer on androgen‐deprivation therapy (ADT): results from the Shared Equal Access Regional Cancer Hospital (SEARCH) database

Study Type – Harm (cohort) Level of Evidence 2b What’s known on the subject? and What does the study add? Prior studies have shown that men undergoing ADT tend to gain weight, with a net increase in fat mass and decrease in bone density and lean body mass. We sought to characterize the natural history of weight gain on ADT by studying patients over a three‐year interval, finding that most weight gain occurs within the first year of initiating therapy. Furthermore, we confirm these prior findings in a more racially heterogeneous population of men, an important finding given the different outcomes of prostate cancer in black and white men.

OBJECTIVES

• ? To better understand the natural history of weight change with androgen‐deprivation therapy (ADT), we investigated the effect of ADT on body weight among men from the Shared Equal Access Regional Cancer Hospital (SEARCH) database.
• ? Men undergoing ADT lose lean muscle but gain fat mass, contributing to an overall gain in weight.

PATIENTS AND METHODS

• ? We identified 132 men in SEARCH who received ADT after radical prostatectomy.
• ? ‘Weight change’ was defined as the difference in weight before starting ADT (6 months before ADT) and the on‐ADT weight (between 6 and 18 months after starting ADT).
• ? In a subanalysis, baseline characteristics of weight‐gainers and ‐losers were analysed using univariate and multivariate analysis to test association with weight change.

RESULTS

• ? In all, 92 men (70%) gained weight, and 40 (30%) either lost or maintained a stable weight.
• ? On average, weight on ADT was 2.2 kg higher than the weight before ADT, with the mean change for weight‐gainers and ‐losers being +4.2 kg and ?2.4 kg, respectively.
• ? This compared with no significant weight change in the year before starting ADT (paired t‐test, change ?0.7 kg, P= 0.19) or in the second year on ADT (paired t‐test, change ?0.5 kg, P= 0.46) for 84 men in whom these additional weight values were recorded.
• ? There was no significant association between any of the features examined and weight change on univariate and multivariate analysis.

CONCLUSION

• ? In this longitudinal study, ADT was accompanied by significant weight gain (+2.2 kg). This change occurred primarily in the first year of therapy, with men neither losing nor gaining additional weight thereafter.

     

Significance of histological prostatitis in patients with urinary retention and underlying benign prostatic hyperplasia or adenocarcinoma of the prostate

What's known on the subject? and What does the study add? It is known that histological prostatitis is associated with a significantly higher risk for acute urinary retention in men with BPH. This study showed that, in men with BPH, histological prostatitis was associated with urinary retention at a significantly younger age and with higher serum PSA levels. In men with ACP, histological prostatitis was associated with urinary retention at an earlier stage of cancer. Study Type – Prognosis (individual cohort) Level of Evidence 2b

OBJECTIVE

• ? To compare the clinical features of patients having urinary retention and benign prostatic hyperplasia (BPH) with those having adenocarcinoma of the prostate (ACP) and to evaluate the significance of histological prostatitis.

PATIENTS AND METHODS

• ? The clinical data and histopathology reports of patients with retention admitted to Tygerberg Hospital between September 1998 and June 2007 were evaluated.
• ? Statistical analysis was performed with Student's t‐test, Mann–Whitney test and Fisher's exact test where appropriate and P < 0.05 was considered to indicate statistical significance.

RESULTS

• ? Prostatic histology was available in 405 patients, 204 with BPH and 201 with ACP.
• ? Comparing those with BPH and those with ACP showed statistically significant differences in mean age (69.5 vs 71.9 years), serum prostate‐specific antigen (PSA) level (18.6 vs 899.5 ng/mL) and histological prostatitis (48 vs 25%) but not duration of catheterization, prostate volume or urinary tract infection (UTI).
• ? Comparing those with BPH only and those with BPH plus prostatitis showed significant differences in mean age (71.9 vs 67.1 year) and PSA level (14.6 vs 22.8 ng/mL) but not prostate volume, UTI or duration of catheterization.
• ? Comparing those with ACP only and those with ACP plus prostatitis showed significant differences in stage T4 cancer (68.1 vs 35.4%) and PSA level (1123.4 vs 232.4 ng/mL) but not age, prostate volume, UTI or duration of catheterization.

CONCLUSIONS

• ? Histological prostatitis was almost twice as common in patients with urinary retention associated with underlying BPH than in patients with ACP, but there was no significant difference in the duration of catheterization, prostatic volume or presence of UTI, suggesting that histological prostatitis more often contributes to the development of retention in patients with underlying BPH than in those with ACP.
• ? In patients with BPH, histological prostatitis was associated with urinary retention at a significantly younger age and with higher serum PSA levels.
• ? In patients with ACP, histological prostatitis was associated with urinary retention at an earlier stage of cancer.

     

Single-stage segmental urethral replacement using combined ventral onlay fasciocutaneous flap with dorsal onlay buccal grafting for long segment strictures

Study Type – Therapy (case series) Level of Evidence 4

What's known on the subject? and What does the study add?

Single‐stage urethral segment replacement has historically poor outcomes and two‐stage repairs are now more common. We present a novel approach to the single‐stage repair with initial outcomes similar to two‐stage repairs.

OBJECTIVE

• ? To present our experience with repairing long‐segment urethralstrictures in a single‐stage using a combined tissue‐transfer technique.

PATIENTS AND METHODS

• ? In all, 14 men underwent urethroplasty where a segment of urethra was completely replaced using a dorsal onlay buccal mucosa graft and a ventral onlay fasciocutaneous flap in a singlestage.
• ? Primary success was defined as an open urethra at >6 months follow‐up with no need for additional surgical intervention.
• ? Secondary success was defined as the need for a single postoperative endoscopic procedure before stricture stabilization.
• ? Failure was the need for multiple endoscopic procedures, repeat urethroplasty, urinary diversion or intermittent dilatation.

RESULTS

• ? The mean (sd ) stricture length was 9.75 (4.6) cm. The mean (sd ) neourethral length was 5.4 (2.7) cm. Stricture location was penile/bulbar in 12men, and bulbar alone in two. Primary success was achieved in nine of the 14 men at a median (range) follow‐up of 2.5 (0.5–9.43) years.
• ? The mean (sd ) time to recurrence in the five initial failures was 340 (376) days.
• ? Secondary success was achieved in two men after a single endoscopic procedure for an overall success in 11 of 14 men.
• ? Patients that recurred had longer strictures (12.8 vs 8.7 cm, P= 0.04) than initial successes, but neourethral lengths were similar (6.2 vs 5.1 cm, P= 0.5).
• ? In all, three of the 14 men failed, two of whom required a repeat urethroplasty.

CONCLUSIONS

• ? Our initial outcomes were favourable using the combined tissue‐transfer technique for segmental urethral replacement with initial and secondary success rates similar to those reported for two‐stage repairs.
• ? This technique is not suitable for all patients as it requires healthy penile skin, but appears to be effective when a single‐stage repair is desirable.