Conservative interventions for managing urinary incontinence after prostate surgery.

BACKGROUND: Men may need to undergo prostate surgery to treat prostate cancer or benign prostatic hyperplasia. After these surgeries, men may experience urinary incontinence (UI). Conservative treatments such as pelvic floor muscle training (PFMT), electrical stimulation and lifestyle changes can be undertaken to help manage the symptoms of UI. OBJECTIVES: To assess the effects of conservative interventions for managing urinary incontinence after prostate surgery. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearched journals and conference proceedings (searched 22 April 2022). We also searched the reference lists of relevant articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs of adult men (aged 18 or over) with UI following prostate surgery for treating prostate cancer or LUTS/BPO. We excluded cross-over and cluster-RCTs. We investigated the following key comparisons: PFMT plus biofeedback versus no treatment; sham treatment or verbal/written instructions; combinations of conservative treatments versus no treatment, sham treatment or verbal/written instructions; and electrical or magnetic stimulation versus no treatment, sham treatment or verbal/written instructions. DATA COLLECTION AND ANALYSIS: We extracted data using a pre-piloted form and assessed risk of bias using the Cochrane risk of bias tool. We used the GRADE approach to assess the certainty of outcomes and comparisons included in the summary of findings tables. We used an adapted version of GRADE to assess certainty in results where there was no single effect measurement available. MAIN RESULTS: We identified 25 studies including a total of 3079 participants. Twenty-three studies assessed men who had previously undergone radical prostatectomy or radical retropubic prostatectomy, while only one study assessed men who had undergone transurethral resection of the prostate. One study did not report on previous surgery. Most studies were at high risk of bias for at least one domain. The certainty of evidence assessed using GRADE was mixed. PFMT plus biofeedback versus no treatment, sham treatment or verbal/written instructions Four studies reported on this comparison. PFMT plus biofeedback may result in greater subjective cure of incontinence from 6 to 12 months (1 study; n = 102; low-certainty evidence). However, men undertaking PFMT and biofeedback may be less likely to be objectively cured at from 6 to 12 months (2 studies; n = 269; low-certainty evidence). It is uncertain whether undertaking PFMT and biofeedback has an effect on surface or skin-related adverse events (1 study; n = 205; very low-certainty evidence) or muscle-related adverse events (1 study; n = 205; very low-certainty evidence). Condition-specific quality of life, participant adherence to the intervention and general quality of life were not reported by any study for this comparison. Combinations of conservative treatments versus no treatment, sham treatment or verbal/written instructions Eleven studies assessed this comparison. Combinations of conservative treatments may lead to little difference in the number of men being subjectively cured or improved of incontinence between 6 and 12 months (RR 0.97, 95% CI 0.79 to 1.19; 2 studies; n = 788; low-certainty evidence; in absolute terms: no treatment or sham arm: 307 per 1000 and intervention arm: 297 per 1000). Combinations of conservative treatments probably lead to little difference in condition-specific quality of life (MD -0.28, 95% CI -0.86 to 0.29; 2 studies; n = 788; moderate-certainty evidence) and probably little difference in general quality of life between 6 and 12 months (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; n = 742; moderate-certainty evidence). There is little difference between combinations of conservative treatments and control in terms of objective cure or improvement of incontinence between 6 and 12 months (MD 0.18, 95% CI -0.24 to 0.60; 2 studies; n = 565; high-certainty evidence). However, it is uncertain whether participant adherence to the intervention between 6 and 12 months is increased for those undertaking combinations of conservative treatments (RR 2.08, 95% CI 0.78 to 5.56; 2 studies; n = 763; very low-certainty evidence; in absolute terms: no intervention or sham arm: 172 per 1000 and intervention arm: 358 per 1000). There is probably no difference between combinations and control in terms of the number of men experiencing surface or skin-related adverse events (2 studies; n = 853; moderate-certainty evidence), but it is uncertain whether combinations of treatments lead to more men experiencing muscle-related adverse events (RR 2.92, 95% CI 0.31 to 27.41; 2 studies; n = 136; very low-certainty evidence; in absolute terms: 0 per 1000 for both arms). Electrical or magnetic stimulation versus no treatment, sham treatment or verbal/written instructions We did not identify any studies for this comparison that reported on our key outcomes of interest. AUTHORS' CONCLUSIONS: Despite a total of 25 trials, the value of conservative interventions for urinary incontinence following prostate surgery alone, or in combination, remains uncertain. Existing trials are typically small with methodological flaws. These issues are compounded by a lack of standardisation of the PFMT technique and marked variations in protocol concerning combinations of conservative treatments. Adverse events following conservative treatment are often poorly documented and incompletely described. Hence, there is a need for large, high-quality, adequately powered, randomised control trials with robust methodology to address this subject.

Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults.

BACKGROUND: Around 16% of adults have symptoms of overactive bladder (OAB; urgency with frequency and/or urge incontinence), with prevalence increasing with age. Anticholinergic drugs are commonly used to treat this condition. This is an update of a Cochrane Review first published in 2002 and last updated in 2006. OBJECTIVES: To assess the effects of anticholinergic drugs compared with placebo or no treatment for treating overactive bladder syndrome in adults. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 14 January 2020), and the reference lists of relevant articles. We updated this search on 3 May 2022, but these results have not yet been fully incorporated. SELECTION CRITERIA: We included randomised or quasi-randomised trials in adults with overactive bladder syndrome that compared an anticholinergic drug alone with placebo treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility and extracted data from the included studies, including an assessment of the risk of bias. We assessed the certainty of the body of evidence using the GRADE approach. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: We included 104 studies, 71 of which were new or updated for this version of the review. Although 12 studies did not report the number of participants, there were 47,106 people in the remainder of the included studies. The majority of the studies had insufficient information to allow judgement of risk of bias and we judged them to be unclear for all domains. Nine anticholinergic drugs were included in these studies: darifenacin; fesoterodine; imidafenacin; oxybutynin; propantheline; propiverine; solifenacin; tolterodine and trospium. No studies were found that compared anticholinergic drugs to no treatment. At the end of the treatment period, anticholinergics may slightly increase condition-specific quality of life (mean difference (MD) 4.41 lower, 95% confidence interval (CI) 5.28 lower to 3.54 lower (scale range -100 to 0); 12 studies, 6804 participants; low-certainty evidence). Anticholinergics are probably better than placebo in terms of patient perception of cure or improvement (risk ratio (RR) 1.38, 95% CI 1.15 to 1.66; 9 studies, 8457 participants; moderate-certainty evidence), and the mean number of urgency episodes per 24-hour period (MD 0.85 lower, 95% CI 1.03 lower to 0.67 lower; 23 studies, 16,875 participants; moderate-certainty evidence). Compared to placebo, anticholinergics may result in an increase in dry mouth adverse events (RR 3.50, 95% CI 3.26 to 3.75; 66 studies, 38,368 participants; low-certainty evidence), and may result in an increased risk of urinary retention (RR 3.52, 95% CI 2.04 to 6.08; 17 studies, 7862 participants; low-certainty evidence). Taking anticholinergics may be more likely to lead to participants withdrawing from the studies due to adverse events (RR 1.37, 95% CI 1.21 to 1.56; 61 studies, 36,943 participants; low-certainty evidence). However, taking anticholinergics probably reduces the mean number of micturitions per 24-hour period compared to placebo (MD 0.85 lower, 95% CI 0.98 lower to 0.73 lower; 30 studies, 19,395 participants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: The use of anticholinergic drugs by people with overactive bladder syndrome results in important but modest improvements in symptoms compared with placebo treatment. In addition, recent studies suggest that this is generally associated with only modest improvement in quality of life. Adverse effects were higher with all anticholinergics compared with placebo. Withdrawals due to adverse effects were also higher for all anticholinergics except tolterodine. It is not known whether any benefits of anticholinergics are sustained during long-term treatment or after treatment stops.

PROTOCOL: Methods used in the development, production and updating of evidence and gap maps: A scoping review.

Evidence and gap maps (EGMs) are an increasinly popular approach used in evidence synthesis. As an approach they address broad research questions, describing the existing evidence base, highlighting evidence gaps and providing an interactive visual tool for knowledge users. The purpose of this methodological study is to explore the the processes used in the development of EGM's and how they are reported. The aim is to better understand current practice and identify where clearer guidance is needed to support their production.

Non-pharmaceutical primary care interventions to improve mental health in deprived populations: a systematic review.

BACKGROUND: Common mental health disorders are especially prevalent among people from socioeconomically disadvantaged backgrounds. Non-pharmaceutical primary care interventions, such as social prescribing and collaborative care, provide alternatives to pharmaceutical treatments for common mental health disorders, but little is known about the impact of these interventions for patients who are socioeconomically disadvantaged. AIM: To synthesise evidence for the effects of non-pharmaceutical primary care interventions on common mental health disorders and associated socioeconomic inequalities. DESIGN AND SETTING: Systematic review of quantitative primary studies published in English and undertaken in high-income countries. METHOD: Six bibliographic databases were searched and additional grey literature sources screened. Data were extracted onto a standardised proforma and quality assessed using the Effective Public Health Practice Project tool. Data were synthesised narratively and effect direction plots were produced for each outcome. RESULTS: Thirteen studies were included. Social-prescribing interventions were evaluated in 10 studies, collaborative care in two studies, and a new model of care in one study. Positive results (based on effect direction) were reported for the impact of the interventions on wellbeing in groups that were socioeconomically deprived. Inconsistent (mainly positive) results were reported for anxiety and depression. One study reported that people from the group with least deprivation, compared with the group with greatest deprivation, benefitted most from these interventions. Overall, study quality was weak. CONCLUSION: Targeting non-pharmaceutical primary care interventions at areas of socioeconomic deprivation may help to reduce inequalities in mental health outcomes. However, only tentative conclusions can be drawn from the evidence in this review and more-robust research is required.

Experiences of Non-Pharmaceutical Primary Care Interventions for Common Mental Health Disorders in Socioeconomically Disadvantaged Groups: A Systematic Review of Qualitative Studies.

Common mental health disorders (CMDs) disproportionately affect people experiencing socioeconomic disadvantage. Non-pharmaceutical interventions, such as 'social prescribing' and new models of care and clinical practice, are becoming increasingly prevalent in primary care. However, little is known about how these interventions work and their impact on socioeconomic inequalities in health. Focusing on people experiencing socioeconomic disadvantage, this systematic review aims to: (1) explore the mechanisms by which non-pharmaceutical primary care interventions impact CMD-related health outcomes and inequalities; (2) identify the barriers to, and facilitators of, their implementation in primary care. This study is a systematic review of qualitative studies. Six bibliographic databases were searched (Medline, ASSIA, CINAHL, Embase, PsycInfo and Scopus) and additional grey literature sources were screened. The included studies were thematically analysed. Twenty-two studies were included, and three themes were identified: (1) agency; (2) social connections; (3) socioeconomic environment. The interventions were experienced as being positive for mental health when people felt a sense of agency and social connection. The barriers to effectiveness and engagement included socioeconomic deprivation and underfunding of community sector organisations. If non-pharmaceutical primary care interventions for CMDs are to avoid widening health inequalities, key socioeconomic barriers to their accessibility and implementation must be addressed.

Clinical and cost effectiveness of endoscopic bipolar radiofrequency ablation for the treatment of malignant biliary obstruction: a systematic review.

Background: Early evidence suggests that using radiofrequency ablation as an adjunct to standard care (i.e. endoscopic retrograde cholangiopancreatography with stenting) may improve outcomes in patients with malignant biliary obstruction. Objectives: To assess the clinical effectiveness, cost-effectiveness and potential risks of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction, and the value of future research. Data sources: Seven bibliographic databases, three websites and seven trials registers were searched from 2008 until 21 January 2021. Review methods: The study inclusion criteria were as follows: patients with biliary obstruction caused by any form of unresectable malignancy; the intervention was reported as an endoscopic biliary radiofrequency ablation to ablate malignant tissue that obstructs the bile or pancreatic ducts, either to fit a stent (primary radiofrequency ablation) or to clear an obstructed stent (secondary radiofrequency ablation); the primary outcomes were survival, quality of life or procedure-related adverse events; and the study design was a controlled study, an observational study or a case report. Risk of bias was assessed using Cochrane tools. The primary analysis was meta-analysis of the hazard ratio of mortality. Subgroup analyses were planned according to the type of probe, the type of stent (i.e. metal or plastic) and cancer type. A de novo Markov model was developed to model cost and quality-of-life outcomes associated with radiofrequency ablation in patients with primary advanced bile duct cancer. Insufficient data were available for pancreatic cancer and secondary bile duct cancer. An NHS and Personal Social Services perspective was adopted for the analysis. A probabilistic analysis was conducted to estimate the incremental cost-effectiveness ratio for radiofrequency ablation and the probability that radiofrequency ablation was cost-effective at different thresholds. The population expected value of perfect information was estimated in total and for the effectiveness parameters. Results: Sixty-eight studies (1742 patients) were included in the systematic review. Four studies (336 participants) were combined in a meta-analysis, which showed that the pooled hazard ratio for mortality following primary radiofrequency ablation compared with a stent-only control was 0.34 (95% confidence interval 0.21 to 0.55). Little evidence relating to the impact on quality of life was found. There was no evidence to suggest an increased risk of cholangitis or pancreatitis, but radiofrequency ablation may be associated with an increase in cholecystitis. The results of the cost-effectiveness analysis were that the costs of radiofrequency ablation was £2659 and radiofrequency ablation produced 0.18 quality-adjusted life-years, which was more than no radiofrequency ablation on average. With an incremental cost-effectiveness ratio of £14,392 per quality-adjusted life-year, radiofrequency ablation was likely to be cost-effective at a threshold of £20,000 per quality-adjusted life-year across most scenario analyses, with moderate uncertainty. The source of the vast majority of decision uncertainty lay in the effect of radiofrequency ablation on stent patency. Limitations: Only 6 of 18 comparative studies contributed to the survival meta-analysis, and few data were found concerning secondary radiofrequency ablation. The economic model and cost-effectiveness meta-analysis required simplification because of data limitations. Inconsistencies in standard reporting and study design were noted. Conclusions: Primary radiofrequency ablation increases survival and is likely to be cost-effective. The evidence for the impact of secondary radiofrequency ablation on survival and of quality of life is limited. There was a lack of robust clinical effectiveness data and, therefore, more information is needed for this indication. Future work: Future work investigating radiofrequency ablation must collect quality-of-life data. High-quality randomised controlled trials in secondary radiofrequency ablation are needed, with appropriate outcomes recorded. Study registration: This study is registered as PROSPERO CRD42020170233. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 7. See the NIHR Journals Library website for further project information.

The bile and pancreatic ducts transport fluids to the intestines to help people digest their food properly. Some types of cancer can cause these ducts to become totally or partially blocked. We wanted to know if endoscopic radiofrequency ablation is safe and works well to treat people who have one of these blockages that cannot be removed by surgery. Radiofrequency ablation burns away a blockage by hitting it with radio waves. Endoscopic means that the radio waves are directed to the blockage using a thin, tube-like wire with a camera at the end. During radiofrequency ablation, a person might have a small tube called a stent put into their bile or pancreatic duct to keep it open or to replace an already blocked stent.

We searched for research studies that looked at (1) whether or not radiofrequency ablation was able to remove blockages from the ducts, (2) if radiofrequency ablation allowed people to live longer, (3) if patients had a better quality of life after radiofrequency ablation, (4) if radiofrequency ablation caused any side effects and (5) how much it costs to treat people with radiofrequency ablation.

We found that treatment with radiofrequency ablation before giving a person a stent helped them to live a little longer with their cancer. We did not find any evidence that radiofrequency ablation increased pain or swelling in the bile duct or pancreatic duct. Radiofrequency ablation might cause more swelling in the gall bladder than having a stent without radiofrequency ablation, but there was not enough research available for us to be certain of this.

Radiofrequency ablation before inserting a stent could be a safe option to add to treatment of bile and pancreatic duct blockages caused by cancer. There is limited research evidence and so we are unable to recommend radiofrequency ablation as a treatment for standard clinical practice.

Economic evaluations of interventions to prevent and control health-care-associated infections: a systematic review.

Almost 9 million health-care-associated infections have been estimated to occur each year in European hospitals and long-term care facilities, and these lead to an increase in morbidity, mortality, bed occupancy, and duration of hospital stay. The aim of this systematic review was to review the cost-effectiveness of interventions to limit the spread of health-care-associated infections), framed by WHO infection prevention and control core components. The Embase, National Health Service Economic Evaluation Database, Database of Abstracts of Reviews of Effects, Health Technology Assessment, Cinahl, Scopus, Pediatric Economic Database Evaluation, and Global Index Medicus databases, plus grey literature were searched for studies between Jan 1, 2009, and Aug 10, 2022. Studies were included if they reported interventions including hand hygiene, personal protective equipment, national-level or facility-level infection prevention and control programmes, education and training programmes, environmental cleaning, and surveillance. The British Medical Journal checklist was used to assess the quality of economic evaluations. 67 studies were included in the review. 25 studies evaluated methicillin-resistant Staphylococcus aureus outcomes. 31 studies evaluated screening strategies. The assessed studies that met the minimum quality criteria consisted of economic models. There was some evidence that hand hygiene, environmental cleaning, surveillance, and multimodal interventions were cost-effective. There were few or no studies investigating education and training, personal protective equipment or monitoring, and evaluation of interventions. This Review provides a map of cost-effectiveness data, so that policy makers and researchers can identify the relevant data and then assess the quality and generalisability for their setting.