A self-help diet and physical activity intervention with dietetic support for weight management in men treated for prostate cancer: pilot study of the Prostate Cancer Weight Management (PRO-MAN) randomised controlled trial.

Overweight and obesity may increase risk of disease progression in men with prostate cancer, but there have been few studies of weight loss interventions in this patient group. In this study overweight or obese men treated for prostate cancer were randomised to a self-help diet and activity intervention with telephone-based dietitian support or a wait-list mini-intervention group. The intervention group had an initial group meeting, a supporting letter from their urological consultant, three telephone dietitian consultations at 4-week intervals, a pedometer and access to web-based diet and physical activity resources. At 12 weeks, men in both groups were given digital scales for providing follow-up weight measurements, and the wait-list group received a mini-intervention of the supporting letter, a pedometer and access to the web-based resources. Sixty-two men were randomised; fifty-four completed baseline and 12-week measurements, and fifty-one and twenty-seven provided measurements at 6 and 12 months, respectively. In a repeated-measures model, mean difference in weight change between groups (wait-list mini-intervention minus intervention) at 12 weeks was -2·13 (95 % CI -3·44, -0·82) kg (P = 0·002). At 12 months the corresponding value was -2·43 (95 % CI -4·50, -0·37) kg (P = 0·022). Mean difference in global quality of life score change between groups at 12 weeks was 12·3 (95 % CI 4·93, 19·7) (P = 0·002); at 12 months there were no significant differences between groups. Results suggest the potential of self-help diet and physical activity intervention with trained support for modest but sustained weight loss in this patient group.

Communicating good care: a qualitative study of what people with urological cancer value in interactions with health care providers.

PURPOSE: Communication with health care providers is important to help meet cancer patients' information and support needs. It can significantly affect the extent to which patients feel cared for, respected and involved, and it can influence a range of cancer care processes and outcomes. This paper presents findings from a study which explored urological cancer patients' experiences of care, focussing on insights into what they appeared to value in their interactions with health care providers and why. METHOD: In-depth interviews were undertaken with 20 men and 6 women with different types of urological cancer at a range of times since diagnosis. Interviews were audio-recorded, transcribed and thematically analysed using an established interpretive approach. RESULTS: Patients valued being treated as someone who mattered and was worthy of care; being recognised and responded to as an individual; and experiencing support for autonomy/agency. Reasons for their valuations related to the implications of communicative interactions for the ways patients thought health professionals related to them 'as persons'. Our findings highlight the value of relational aspects of communication for: indicating to patients what clinicians think of their worth; facilitating individualised care; and enabling patients to contribute to their own care. CONCLUSIONS: Efforts to improve health care provider-patient communication should attend not only to the transfer of information about the condition and its management but to the range of features of interactions that can signal to people how health care providers relate to them as persons.

Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial).

BACKGROUND: Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the UK NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including the use of antimicrobial catheters. However, there is considerable uncertainty regarding their usefulness in terms of reducing symptomatic CAUTI, and whether or not they are cost-effective. OBJECTIVES: Do antimicrobial catheters reduce the rate of symptomatic urinary tract infection (UTI) during short-term hospital use and is their use cost-effective for the UK NHS? DESIGN: A pragmatic multicentre UK randomised controlled trial comparing three catheters as they would be used in the UK NHS: antimicrobial-impregnated (nitrofurazone) and antiseptic-coated (silver alloy) catheters with the standard polytetrafluoroethylene (PTFE)-coated catheters. Economic evaluation used a decision model populated with data from the trial. Sensitivity analysis was used to explore uncertainty. SETTING: Relevant clinical departments in 24 NHS hospitals throughout the UK. PARTICIPANTS: Adults requiring temporary urethral catheterisation for a period of between 1 and 14 days as part of their care, predominantly as a result of elective surgery. INTERVENTIONS: Eligible participants were randomised 1 : 1 : 1 to one of three types of urethral catheter in order to make the following pragmatic comparisons: nitrofurazone-impregnated silicone catheter compared with standard PTFE-coated latex catheter; and silver alloy-coated hydrogel latex catheter compared with standard PTFE-coated latex catheter. MAIN OUTCOME MEASURES: The primary outcome for clinical effectiveness was the incidence of UTI at any time up to 6 weeks post randomisation. This was defined as any symptom reported during catheterisation, up to 3 days or 1 or 2 weeks post catheter removal or 6 weeks post randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI. The primary economic outcome was incremental cost per quality-adjusted life-year (QALY). Health-care costs were estimated from NHS sources with QALYs calculated from participant completion of the European Quality of Life-5 Dimensions (EQ-5D). RESULTS: Outcome analyses encompassed 6394 (90%) of 7102 participants randomised. The rate of symptomatic UTI within 6 weeks of randomisation was 10.6% in the nitrofurazone group (n = 2153; -2.1% absolute risk difference), 12.5% in the silver alloy group (n = 2097; -0.1% absolute risk difference) and 12.6% in the PTFE group (n = 2144). The effect size {odds ratio (OR) [97.5% confidence interval (CI)]} was 0.82 (97.5% CI 0.66 to 1.01) for nitrofurazone (p = 0.037) and 0.99 (97.5% CI 0.81 to 1.22) for silver alloy (p = 0.92) catheters. The nitrofurazone catheters were more likely to cause discomfort during use and on removal. The primary economic analysis suggested that nitrofurazone-impregnated catheters would be, on average, the least costly (> £7 less than PTFE) and most effective option at current NHS prices. There was a 73% chance that nitrofurazone would be cost saving and an 84% chance that the incremental cost per QALY would be < £30,000. At the trial price (£6.46), silver alloy catheters were very unlikely to be cost-effective. These results were unchanged in sensitivity analyses, although when the length of stay cost was excluded the incremental cost per QALY for nitrofurazone against PTFE was £28,602. CONCLUSIONS: The trial estimate of clinical effectiveness for nitrofurazone-impregnated catheters was less than the pre-specified minimum absolute risk difference that we considered important (-3.3%), and the surrounding CI included zero, indicating that any reduction in catheter-associated UTI was uncertain. Economic analysis, although associated with uncertainty, suggested that nitrofurazone-impregnated catheters may be cost-effective for the NHS. The trial ruled out the possibility that silver alloy-coated catheters might reach the pre-set degree of clinical effectiveness and that their use was unlikely to be cost-effective. These findings should be considered by patients, clinicians and health-care policy-makers to determine whether or not a change in practice is worthwhile. Future research should be aimed at determining the minimum clinically important difference in terms of CAUTI prevention in comparative trials, and to identify reliable methods which can detect the impact of the intervention on quality of life and other drivers of cost, when the intervention is a subsidiary part of overall treatment plans.

Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.

OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical prostatectomy or a transurethral resection of the prostate (TURP). BACKGROUND: Urinary incontinence after radical prostate surgery is common immediately after surgery, although the chance of incontinence is less after TURP than following radical prostatectomy. DESIGN: Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial prostatectomy and TURP. SETTING: Men having prostate surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. PARTICIPANTS: Men with urinary incontinence at 6 weeks after prostate surgery were eligible to be randomised if they consented and were able to comply with the intervention. INTERVENTIONS: Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. MAIN OUTCOME MEASURES: The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. RESULTS: Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [£ 181.02 (95% CI £ 107 to £ 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [£ 209 (95% CI £ 147 to £ 271)] and societal costs [£ 420 (95% CI £ 54 to £ 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. CONCLUSIONS: The provision of one-to-one conservative physical therapy for men with urinary incontinence after prostate surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.

Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence (SUI) through systematic review and economic modelling. DATA SOURCES: The Cochrane Incontinence Group Specialised Register, electronic databases and the websites of relevant professional organisations and manufacturers, and the following databases: CINAHL, EMBASE, BIOSIS, Science Citation Index and Social Science Citation Index, Current Controlled Trials, ClinicalTrials.gov and the UKCRN Portfolio Database. STUDY SELECTION: The study comprised three distinct elements. (1) A survey of 188 women with SUI to identify outcomes of importance to them (activities of daily living; sex, hygiene and lifestyle issues; emotional health; and the availability of services). (2) A systematic review and meta-analysis of non-surgical treatments for SUI to find out which are most effective by comparing results of trials (direct pairwise comparisons) and by modelling results (mixed-treatment comparisons - MTCs). A total of 88 randomised controlled trials (RCTs) and quasi-RCTs reporting data from 9721 women were identified, considering five generic interventions [pelvic floor muscle training (PFMT), electrical stimulation (ES), vaginal cones (VCs), bladder training (BT) and serotonin-noradrenaline reuptake inhibitor (SNRI) medications], in many variations and combinations. Data were available for 37 interventions and 68 treatment comparisons by direct pairwise assessment. Mixed-treatment comparison models compared 14 interventions, using data from 55 trials (6608 women). (3) Economic modelling, using a Markov model, to find out which combinations of treatments (treatment pathways) are most cost-effective for SUI. DATA EXTRACTION: Titles and abstracts identified were assessed by one reviewer and full-text copies of all potentially relevant reports independently assessed by two reviewers. Any disagreements were resolved by consensus or arbitration by a third person. RESULTS: Direct pairwise comparison and MTC analysis showed that the treatments were more effective than no treatment. Delivering PFMT in a more intense fashion, either through extra sessions or with biofeedback (BF), appeared to be the most effective treatment [PFMT extra sessions vs no treatment (NT) odds ratio (OR) 10.7, 95% credible interval (CrI) 5.03 to 26.2; PFMT + BF vs NT OR 12.3, 95% CrI 5.35 to 32.7]. Only when success was measured in terms of improvement was there evidence that basic PFMT was better than no treatment (PFMT basic vs NT OR 4.47, 95% CrI 2.03 to 11.9). Analysis of cost-effectiveness showed that for cure rates, the strategy using lifestyle changes and PFMT with extra sessions followed by tension-free vaginal tape (TVT) (lifestyle advice-PFMT extra sessions-TVT) had a probability of greater than 70% of being considered cost-effective for all threshold values for willingness to pay for a QALY up to 50,000 pounds. For improvement rates, lifestyle advice-PFMT extra sessions-TVT had a probability of greater than 50% of being considered cost-effective when society's willingness to pay for an additional QALY was more than 10,000 pounds. The results were most sensitive to changes in the long-term performance of PFMT and also in the relative effectiveness of basic PFMT and PFMT with extra sessions. LIMITATIONS: Although a large number of studies were identified, few data were available for most comparisons and long-term data were sparse. Challenges for evidence synthesis were the lack of consensus on the most appropriate method for assessing incontinence and intervention protocols that were complex and varied considerably across studies. CONCLUSIONS: More intensive forms of PFMT appear worthwhile, but further research is required to define an optimal form of more intensive therapy that is feasible and efficient for the NHS to provide, along with further definitive evidence from large, well-designed studies.

Systematic review of the clinical effectiveness and cost-effectiveness of photodynamic diagnosis and urine biomarkers (FISH, ImmunoCyt, NMP22) and cytology for the detection and follow-up of bladder cancer.

OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC), and urine biomarkers [fluorescence in situ hybridisation (FISH), ImmunoCyt, NMP22] and cytology for the detection and follow-up of bladder cancer. DATA SOURCES: Major electronic databases including MEDLINE, MEDLINE In-Process, EMBASE, BIOSIS, Science Citation Index, Health Management Information Consortium and the Cochrane Controlled Trials Register were searched until April 2008. REVIEW METHODS: A systematic review of the literature was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of alternative diagnostic and follow-up strategies for the diagnosis and management of patients with bladder cancer. RESULTS: In total, 27 studies reported PDD test performance. In pooled estimates [95% confidence interval (CI)] for patient-level analysis, PDD had higher sensitivity than WLC [92% (80% to 100%) versus 71% (49% to 93%)] but lower specificity [57% (36% to 79%) versus 72% (47% to 96%)]. Similar results were found for biopsy-level analysis. The median sensitivities (range) of PDD and WLC for detecting lower risk, less aggressive tumours were similar for patient-level detection [92% (20% to 95%) versus 95% (8% to 100%)], but sensitivity was higher for PDD than for WLC for biopsy-level detection [96% (88% to 100%) versus 88% (74% to 100%)]. For more aggressive, higher-risk tumours the median sensitivity of PDD for both patient-level [89% (6% to 100%)] and biopsy-level [99% (54% to 100%)] detection was higher than those of WLC [56% (0% to 100%) and 67% (0% to 100%) respectively]. Four RCTs comparing PDD with WLC reported effectiveness outcomes. PDD use at transurethral resection of bladder tumour resulted in fewer residual tumours at check cystoscopy [relative risk, RR, 0.37 (95% CI 0.20 to 0.69)] and longer recurrence-free survival [RR 1.37 (95% CI 1.18 to 1.59)] compared with WLC. In 71 studies reporting the performance of biomarkers and cytology in detecting bladder cancer, sensitivity (95% CI) was highest for ImmunoCyt [84% (77% to 91%)] and lowest for cytology [44% (38% to 51%)], whereas specificity was highest for cytology [96% (94% to 98%)] and lowest for ImmunoCyt [75% (68% to 83%)]. In the cost-effectiveness analysis the most effective strategy in terms of true positive cases (44) and life-years (11.66) [flexible cystoscopy (CSC) and ImmunoCyt followed by PDD in initial diagnosis and CSC followed by WLC in follow-up] had an incremental cost per life-year of over 270,000 pounds. The least effective strategy [cytology followed by WLC in initial diagnosis (average cost over 20 years 1403 pounds, average life expectancy 11.59)] was most likely to be considered cost-effective when society's willingness to pay was less than 20,000 pounds per life-year. No strategy was cost-effective more than 50% of the time, but four of the eight strategies in the probabilistic sensitivity analysis (three involving a biomarker or PDD) were each associated with a 20% chance of being considered cost-effective. In sensitivity analyses the results were most sensitive to the pretest probability of disease (5% in the base case). CONCLUSIONS: The advantages of PDD's higher sensitivity in detecting bladder cancer have to be weighed against the disadvantages of a higher false-positive rate. Taking into account the assumptions made in the model, strategies involving biomarkers and/or PDD provide additional benefits at a cost that society might be willing to pay. Strategies replacing WLC with PDD provide more life-years but it is unclear whether they are worth the extra cost.

Systematic review and economic modelling of effectiveness and cost utility of surgical treatments for men with benign prostatic enlargement.

OBJECTIVES: To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments. DATA SOURCES: Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs). REVIEW METHODS: Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Cost-effectiveness was assessed using a Markov model reflecting likely care pathways. RESULTS: 156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12-234). TURP provided consistent, high-level, long-term symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation of the prostate (HoLEP) additionally resulted in greater improvement in flow rate. HoLEP is unique amongst the newer technologies in offering an advantage in urodynamic outcomes over TURP, although long-term follow-up data are lacking. Severe blood loss was more common following TURP. Rates of incontinence were similar across all interventions other than transurethral needle ablation (TUNA) and laser coagulation, for which lower rates were reported. Acute retention and reoperation were commoner with newer technologies, especially minimally invasive interventions. The economic model suggested that minimally invasive procedures were unlikely to be cost-effective compared with TURP. Transurethral vaporisation of the prostate (TUVP) was both less costly and less effective than TURP. HoLEP was estimated to be more cost-effective than a single TURP but less effective than a strategy involving repeat TURP if necessary. The base-case analysis suggested an 80% chance that TUVP, followed by HoLEP if required, would be cost-effective at a threshold of 20,000 pounds per quality-adjusted life-year. At a 50,000 pounds threshold, TUVP, followed by TURP as required, would be cost-effective, although considerable uncertainty surrounds this finding. The main limitations are the quantity and quality of the data available, in the context of multiple comparisons. CONCLUSIONS: In the absence of strong evidence in favour of newer methods, the standard--TURP--remains both clinically effective and cost-effective. There is a need for further research to establish (i) how many years of medical treatment are necessary to offset the cost of treatment with a minimally invasive or ablative intervention; (ii) more cost-effective alternatives to TURP; and (iii) strategies to improve outcomes after TURP.

Outcomes of stenting after uncomplicated ureteroscopy: systematic review and meta-analysis.

OBJECTIVE: To investigate the potential beneficial and adverse effects of routine ureteric stent placement after ureteroscopy. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Cochrane controlled trials register (2006 issue 2), Embase, and Medline (1966 to 31 March 2006), without language restrictions. Review methods We included all randomised controlled trials that reported various outcomes with or without stenting after ureteroscopy. Two reviewers independently extracted data and assessed quality. Meta-analyses used both fixed and random effects models with dichotomous data reported as relative risk and continuous data as a weighted mean difference with 95% confidence intervals. RESULTS: Nine randomised controlled trials (reporting 831 participants) were identified. The incidence of lower urinary tract symptoms was significantly higher in participants who had a stent inserted (relative risk 2.25, 95% confidence interval 1.14 to 4.43, for dysuria; 2.00, 1.11 to 3.62, for frequency or urgency) after ureteroscopy. There was no significant difference in postoperative requirement for analgesia, urinary tract infections, stone free rate, and ureteric strictures in the two groups. Because of marked heterogeneity, formal pooling of data was not possible for some outcomes such as flank pain. A pooled analysis showed a reduced likelihood of unplanned medical visits or admission to hospital in the group with stents (0.53, 0.17 to 1.60), although this difference was not significant. None of the trials reported on health related quality of life. Cost reported in three randomised controlled trials favoured the group without stents. The overall quality of trials was poor and reporting of outcomes inconsistent. CONCLUSIONS: Patients with stents after ureteroscopy have significantly higher morbidity in the form of irritative lower urinary symptoms with no influence on stone free rate, rate of urinary tract infection, requirement for analgesia, or long term ureteric stricture formation. Because of the marked heterogeneity and poor quality of reporting of the included trials, the place of stenting in the management of patients after uncomplicated ureteroscopy remains unclear.

Herpetiform cutaneous metastases from transitional cell carcinoma of the urinary bladder: immunohistochemical analysis.

The case of an 83-year-old woman with an uncommon presentation of cutaneous metastases from muscle-invasive transitional cell carcinoma of the urinary bladder is reported. The band-like eruption of the metastatic lesion can often be misdiagnosed and treated initially as herpes zoster. A detailed immunohistochemical analysis is also described to differentiate metastatic lesions from other sources.

Mechanical devices for urinary incontinence in women.

BACKGROUND: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management. The latter more so when a person did not want surgery or when considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. OBJECTIVES: To determine the effects of mechanical devices in the management of adult female urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (7 December 2005). The register contains trials identified from MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and handsearching of journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined either by symptom classification or by urodynamic diagnosis. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2). MAIN RESULTS: There were six trials involving a total of 286 women. Two small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Five trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. There were no trials comparing a mechanical device with another type of treatment. AUTHORS' CONCLUSIONS: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and a large well-conducted trial is required for clarification. There was also insufficient evidence in favour of one device over another and no evidence to compare mechanical devices with other forms of treatment.

Mechanical devices for urinary incontinence in women.

BACKGROUND: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management. The latter more so when a person did not want surgery or when considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. OBJECTIVES: To determine the effects of mechanical devices in the management of adult female urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (7 December 2005). The register contains trials identified from MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and handsearching of journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined either by symptom classification or by urodynamic diagnosis. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2). MAIN RESULTS: There were six trials involving a total of 286 women. Two small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Five trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. There were no trials comparing a mechanical device with another type of treatment. AUTHORS' CONCLUSIONS: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and a large well-conducted trial is required for clarification. There was also insufficient evidence in favour of one device over another and no evidence to compare mechanical devices with other forms of treatment.

Short term urinary catheter policies following urogenital surgery in adults.

BACKGROUND: Urinary catheterisation (by the urethral or suprapubic routes) is common following urogenital surgery. There is no consensus on how to minimize complications and practice varies. OBJECTIVES: To establish the optimal way to manage urinary catheters following urogenital surgery in adults. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised trials register (searched 30 May 2005) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials were identified. Studies were excluded if they were not randomised or quasi-randomised trials of adults being catheterised following urogenital surgery. DATA COLLECTION AND ANALYSIS: Data collection was performed independently by two of the review authors and cross-checked. Where data might have been collected but not reported, clarification was sought from the trialists. MAIN RESULTS: Thirty nine randomised trials were identified for inclusion in the review. They were generally small and of poor or moderate quality reporting data on only few outcomes. Confidence intervals were all wide. USING A URINARY CATHETER VERSUS NOT USING ONE: The data from five trials were heterogeneous but tended to indicate a higher risk of (re)catheterisation if a catheter was not used postoperatively. The data gave only an imprecise estimate of any difference in urinary tract infection. URETHRAL CATHETERISATION VERSUS SUPRAPUBIC CATHETERISATION: In six trials, a greater number of people needed to be recatheterised if a urethral catheter rather than a suprapubic one was used following surgery (RR 3.66, 95% CI 1.41 to 9.49). SHORTER POSTOPERATIVE DURATION OF CATHETER USE VERSUS LONGER DURATION: In 11 trials, the seven trials with data suggested fewer urinary tract infections when a catheter was removed earlier (for example 1 versus 3 days, RR 0.50, 95% CI 0.29 to 0.87) with no pattern in respect of catheterisation. CLAMP AND RELEASE POLICIES BEFORE CATHETER REMOVAL VERSUS IMMEDIATE CATHETER REMOVAL: In a single small trial, the clamp-and-release group showed a significantly greater incidence of urinary tract infections (RR 4.00, 95% 1.55 to 10.29) and a delay in return to normal voiding (RR 2.50, 95% CI 1.16 to 5.39). AUTHORS' CONCLUSIONS: Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation.

Does retrograde balloon dilation compromise outcome of secondary open pyeloplasty: 17 years' experience at a single center.

OBJECTIVES: To determine whether the outcome of secondary open pyeloplasty is compromised by previous retrograde balloon dilation. METHODS: Patients undergoing secondary open pyeloplasty after retrograde balloon dilation (n = 25) were compared with a similar group undergoing primary open pyeloplasty (n = 25) at the same institution. Patients were assessed by renography before and after surgery, and postoperative success was determined by the complete absence of pain. RESULTS: In the primary pyeloplasty group, the success rate was 96%, with a mean follow-up of 33 months (range 17 to 53). In the secondary pyeloplasty group, the success rate was 88%, with a mean follow-up of 20 months (range 9 to 32). No statistically significant difference was found in the success rates between the two groups (P = 0.6). CONCLUSIONS: Treatment failures after retrograde balloon dilation can be salvaged by secondary pyeloplasty with no detriment to the chance of long-term success compared with primary pyeloplasty.

Adrenergic drugs for urinary incontinence in adults.

BACKGROUND: Adrenergic drugs have been used for the treatment of urinary incontinence. However, they have generally been considered to be ineffective or to have side effects which may limit their clinical use. OBJECTIVES: To determine the effectiveness of adrenergic agonists in the treatment of urinary incontinence in adults. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised trials register (searched 9 March 2005) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in adults with urinary incontinence which included an adrenergic agonist drug in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Reviewers' Handbook. MAIN RESULTS: Twenty-two eligible randomised trials were identified, of which 11 were crossover trials. The trials included 1099 women with 673 receiving an adrenergic drug (phenylpropanolamine in 11 trials, midodrine in two, norepinephrine in three, clenbuterol in another three, terbutaline in one, eskornade in one and Ro-115-1240 in one). No trials included men. The limited evidence suggested that an adrenergic agonist drug is better than placebo in reducing the number of pad changes and incontinence episodes, as well as improving subjective symptoms. In two small trials, the drugs also appeared to be better than pelvic floor muscle training, possibly reflecting relative acceptability of the treatments to women but perhaps due to differential withdrawal of women from the trial groups. There was not enough evidence to evaluate the use of higher compared to lower doses of adrenergic agonists nor the relative merits of an adrenergic agonist drug compared with oestrogen, whether used alone or in combination. Over a quarter of women reported adverse effects. There were similar numbers of adverse effects with adrenergics, placebo or alternative drug treatment. However, when these were due to recognised adrenergic stimulation (insomnia, restlessness and vasomotor stimulation) they were only severe enough to stop treatment in 4% of women. AUTHORS' CONCLUSIONS: There was weak evidence to suggest that use of an adrenergic agonist was better than placebo treatment. There was not enough evidence to assess the effects of adrenergic agonists when compared to or combined with other treatments. Further larger trials are needed to identify when adrenergics may be useful. Patients using adrenergic agonists may suffer from minor side effects, which sometimes cause them to stop treatment. Rare but serious side effects, such as cardiac arrhythmias and hypertension, have been reported.

Serotonin and noradrenaline reuptake inhibitors (SNRI) for stress urinary incontinence in adults.

BACKGROUND: To date, standard recommendations for the management of stress urinary incontinence (SUI) would be either pelvic floor muscle training (PFMT) or surgery. A new form of drug treatment with a serotonin-noradrenaline reuptake inhibitor (SNRI), duloxetine, may now have a place in treatment of this condition. OBJECTIVES: To determine whether a SNRI is better than placebo (or no treatment, other pharmacological and non-pharmacological therapies, or surgery) in the treatment of women with SUI, or mixed urinary incontinence that includes stress incontinence (MUI), or both and which doses should be used. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register (searched 1 December 2004), (CENTRAL) (Issue 2, 2004), MEDLINE (January 1966 to September 2004), PREMEDLINE (11 March 2004), Dissertation Abstracts and the reference lists of relevant articles. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of treatment for SUI or MUI, in which at least one management arm involved a SNRI. DATA COLLECTION AND ANALYSIS: Two authors evaluated the trials for appropriateness for inclusion and methodological quality. Three authors performed the data extraction using predetermined criteria. Analyses were performed using the Cochrane Review Manager software, RevMan. MAIN RESULTS: Nine randomised trials were included, involving 3327 adults with predominantly SUI, randomised to receive duloxetine or placebo. Both arms in individual trials were comparable for various baseline characteristics. Treatment duration was between three weeks and 12 weeks. Duloxetine was significantly better than placebo in terms of improving patients' quality of life (WMD 5.26, 95%CI 3.84 to 6.68. P< 0.00001) and perception of improvement. Individual studies demonstrated a significant reduction in the Incontinence Episode Frequency (IEF) by approximately 50% during treatment with duloxetine. With regard to objective cure, however, meta-analysis of stress pad test and 24 hour pad weight change failed to demonstrate a benefit for duloxetine over placebo though data were relatively few. Subjective cure favoured duloxetine, albeit with a small effect size (3%). One trial suggested that duloxetine was better than pelvic floor muscle training alone in reducing IEF (P < 0.05) based on median percentage decrease in IEF per week. Although significant side effects were commonly associated with duloxetine, they were reported as acceptable. AUTHORS' CONCLUSIONS: The available evidence suggests that duloxetine treatment can significantly improve the quality of life of patients with stress urinary incontinence, but it is unclear whether or not benefits are sustainable. Adverse effects are common but not serious. About one in three participants allocated duloxetine reported adverse effects (most commonly nausea) related to treatment, and about one in eight allocated duloxetine stopped treatment as a consequence.

Is orthotopic bladder replacement the new gold standard? Evidence from a systematic review.

PURPOSE: In this systematic review we determined whether the outcome of orthotopic bladder replacement is superior to that of continent and incontinent urinary diversion. MATERIALS AND METHODS: We searched MEDLINE, PubMed, EMBASE, CINAHL and the Cochrane Library from January 1990 to January 2003. A total of 3,370 abstracts were reviewed, including all types of studies from prospective, randomized, controlled studies to small, retrospective series. All relevant articles with at least 10 patients and a mean followup of at least 1 year were retrieved. There were no language restrictions. NonEnglish articles were translated. Comparisons were made between the major surgery types, including ileal conduit, continent diversion, bladder reconstruction and bladder replacement. All studies were scored using a predetermined quality assessment checklist to assess internal validity (bias and confounding) and external validity. RESULTS: A total of 405 studies met inclusion criteria. There were 32 prospective and 373 retrospective studies describing a total of 32,795 patients. The majority of studies were incompletely or poorly described and outcomes were often not defined. When they were defined, definitions varied. In clinical outcomes ileal conduit diversions had the lowest operative complications rate but highest reported postoperative morbidity. They also had a higher reported incidence of symptomatic urinary tract infections. The rates of postoperative morbidity, mortality and need for reoperation varied widely among studies even for the same procedure. Of physiological outcomes metabolic acidosis was the most commonly reported metabolic complication in patients with various urinary diversions. The quality of the reported literature was poor. There were no studies of the health economic implications of performing 1 type of surgery vs another type. CONCLUSIONS: While enthusiasts regard orthotopic bladder replacement as the new gold standard when lower urinary tract function must be replaced, the level and quality of current evidence are poor. The immediate concern must be to rectify this paucity of evidence with well designed and well reported prospective studies, ideally in a randomized setting, comparing the various major forms of urinary diversion and bladder replacement surgery.

The bladder does not appear to have a dynamic secreted continuous mucous gel layer.

PURPOSE: We determined whether the nature of any protective barrier in the bladder is composed of a secreted mucous gel layer. MATERIALS AND METHODS: We collected 24-hour urine samples for analysis from 8 healthy 22 to 49-year-old volunteers and 5, 19 to 59-year-old patients treated with bladder reconstruction, in addition to scrapings from 100 freshly slaughtered pig bladders. Samples were subjected to homogenization, dialysis, freeze-drying, papain digestion, gel chromatography, equilibrium density gradient centrifugation, periodic acid-Schiff assay and amino acid analysis. Normal human bladder, pig bladder, normal ileum and transposed intestinal segments were studied for the presence of a mucous layer using a new method of histological analysis. RESULTS: Mucin content in normal urine is 2.7 mg/24 hours, meaning that less than 0.6% of nondialyzable material in normal urine is mucin. The mucin content of urine from reconstructed bladders amounted to 86 mg/24 hours (5.2% of nondialyzable material). We observed that glycosaminoglycans accounted for 41% of the peak total elution volume of PAS positive material in normal urine. Mucin estimation in urine can be grossly overestimated if contaminating glycoconjugates are not removed. Biochemical analysis of material scraped off the pig bladder surface demonstrated that the maximum thickness of a continuous layer that could be achieved was 13.6 mum. While we could visualize an obvious mucous layer on control ileal samples and biopsies of transposed ileal segments from patients with bladder reconstruction, we were unable to note a distinct, measurable mucous layer lining the bladder surface in humans or pigs. CONCLUSIONS: Mucin levels in normal human and pig urine would be enough for slow turnover of a thin barrier but the large increase in mucin in the urine of patients with transposed intestinal segments demonstrates that any layer in normal bladder is much different than that lining the transposed intestinal segment. The most likely constituents of this barrier are membrane bound rather than secreted mucins along with the proteoglycan components of the glycocalix.

Adrenergic drugs for urinary incontinence in adults.

BACKGROUND: Adrenergic drugs have been used for the treatment of urinary incontinence. However, they have generally been considered to be ineffective or to have side effects which may limit their clinical use. OBJECTIVES: To determine the effectiveness of adrenergic agonists in the treatment of urinary incontinence in adults. SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (January 2002) and the reference lists of relevant articles. Date of the most recent searches: January 2002. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials which include an adrenergic agonist drug in at least one arm for adults with urinary incontinence. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Collaboration Handbook. MAIN RESULTS: Fifteen randomised trials were identified, which included 832 women, of whom 506 received an adrenergic drug (phenylpropanolamine in 11 trials, Midodrine in two and Clenbuterol in another two). Of these, six were crossover trials. No trials included men. The limited evidence suggested that an adrenergic agonist drug is better than placebo in reducing number of pad changes and incontinence episodes, as well as improvement in subjective symptoms. The drugs also appeared to be better than pelvic floor muscle training in two small trials, possibly reflecting relative acceptability of the treatments to women but perhaps due to differential withdrawal of women from the trial groups. There was not enough evidence to evaluate the use of higher compared to lower doses of adrenergic agonists nor the relative merits of an adrenergic agonist drug compared with oestrogen, whether used alone or in combination. REVIEWER'S CONCLUSIONS: There was weak evidence to suggest that use of an adrenergic agonist is better than placebo treatment. There was not enough evidence to assess the effects of adrenergic agonists when compared to or combined with other treatments. Patients using adrenergic agonists may suffer from minor side effects, only occasionally leading them to stop treatment. Rare but serious side effects such as cardiac arrhythmias and hypertension have been reported, however.

Periurethral injection therapy for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence is a common, troublesome symptom amongst adult women. Periurethral injection of bulking agents is a surgical procedure used for the treatment of urinary incontinence. OBJECTIVES: To assess the effects of periurethral injection therapy in the treatment of urinary incontinence in women. SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (February 2003), MEDLINE (January 1996 to January 2003), PREMEDLINE (7 February 2003) and the reference lists of relevant articles. Date of the most recent searches: February 2003. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of treatment for urinary incontinence, in which at least one management arm involved periurethral injection therapy. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently using a standard form and clarification concerning possible unreported data sought directly from the investigators. MAIN RESULTS: We identified seven trials that met the inclusion criteria. The limited data available prevented meta-analysis. Injection of autologous fat was compared to placebo in a study of 68 women which was terminated early because of safety concerns. No differences in subjective or objective outcome were found in the two groups. No studies were found comparing injection therapy with conservative treatment. The single study that compared injection with a variety of surgical management in 133 women found no significant difference in subjective outcome but did note significantly better objective outcome in the surgical group. The four studies that compared different agents found that silicone particles and carbon spheres gave improvement at 12 months equivalent to collagen. A comparison of paraurethral and transurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the paraurethral group. REVIEWER'S CONCLUSIONS: Data from the available randomised trials suggest, but do not prove, that periurethral injection of established manufactured bulking agents results in subjective and objective short term improvement of symptomatic female stress urinary incontinence in adults. Future recommendation as a first line treatment would require evidence of patient benefit and cost-effectiveness from randomised trials involving placebo and conservative treatment arms. Future studies should also record long-term outcome and monitor for delayed particle migration. Injection therapy is probably inferior to surgery but a long term comparative study against a single standard procedure (Burch colposuspension) is required to prove this. It is recommended that phase III studies of newer agents will not be worthwhile until the aforementioned trials have been performed and a rationale for the use of injection therapy decided. For women with extensive co-morbidity precluding anaesthesia, injection therapy may represent a useful option for relief of symptoms for a 12 month period although 2 or 3 injections are likely to be required to achieve a satisfactory result.

Characterization of Escherichia coli strains causing urinary tract infections in patients with transposed intestinal segments.

PURPOSE: Transposition of intestinal segments into the urinary tract predisposes to urinary tract infections. We characterized bacterial infections in these patients and examined the virulence genotype and persistence of Escherichia coli isolates. MATERIALS AND METHODS: We followed 26 patients who underwent bladder reconstructive surgery using transposed intestinal segments. E. coli strains isolated from the urine of these patients were genotyped for established virulence determinants and the frequency of carriage was compared with E. coli strains isolated from community acquired urinary infections and the fecal flora of anonymous volunteers. A longitudinal study of E. coli strains in 9 patients was also done using pulsed field gel electrophoresis. RESULTS: E. coli was the most frequently isolated organism, responsible for 59% (62 of 105) of monobacterial infections. Other bacteria isolated included Klebsiella species, Proteus species and Enterococcus faecalis. Community acquired E. coli strains were more likely to carry multiple determinants for particular adhesins (P and S fimbriae) and toxins (alpha-hemolysin and cytotoxic necrotizing factor) than fecal strains. Carriage frequency for bladder reconstruction strains was intermediary and not significantly different. The key finding was that E. coli strains persisted for prolonged periods, including 2 years in certain patients, often despite various antimicrobial treatments. CONCLUSIONS: This study highlights that further steps must be taken to prevent and treat urinary tract infections in this susceptible group. Particular attention should be given to the treatment of persistent infections.