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Sacral neuromodulation for neurogenic bladder and bowel dysfunction after spinal cord disease

Study design: Cost-effectiveness analysis Objective: To establish a model to investigate the cost effectiveness for people with spinal cord injury (SCI), from a lifetime perspective, for the usage of two different single-use catheter designs: hydrophilic-coated (HC) and uncoated (UC). The model includes the long-term sequelae of impaired renal function and urinary tract infection (UTI). Setting: Analysis based on a UK perspective. Methods: A probabilistic Markov decision model was constructed, to compare lifetime costs and quality-adjusted life years, taking renal and UTI health states into consideration, as well as other catheter-related events. UTI event rates for the primary data set were based on data from hospital settings to ensure controlled and accurate reporting. A sensitivity analysis was applied to evaluate best-and worst-case scenarios. Results: The model predicts that a 36-year-old SCI patient with chronic urinary retention will live an additional 1.4 years if using HC catheters compared with UC catheters, at an incremental cost of 2100 pound. Moreover, the lifetime number of UTI events will be reduced by 16%. All best-and worst-case estimates were within the UK threshold of being cost effective. Conclusion: The use of HC catheters for intermittent catheterisation in SCI patients is highly cost effective. The outcome is consistent irrespective of whether UTI data are collected in hospital or community settings.

Summary Aims To systematically review dose-escalation data from flexible-dose studies of fesoterodine and summarise factors associated with dose-escalation decisions. Methods A PubMed search was conducted using the terms (fesoterodine AND flexible dose), with no limits. Articles were included if they contained fesoterodine dose-escalation data for efficacy or safety outcomes or factors associated with dose-escalation decisions. Results Of 13 articles identified by the search, 10 articles (six clinical studies) met inclusion criteria. In flexible-dose trials of fesoterodine, 51–63% of subjects initially receiving fesoterodine 4 mg opted for dose escalation to fesoterodine 8 mg. Escalators generally reported significantly more severe overactive bladder (OAB) symptoms, greater OAB symptom bother and worse health-related quality of life at baseline than non-escalators. Escalators demonstrated less treatment benefit with fesoterodine 4 mg than non-escalators. Non-escalators generally had a higher rate of dry mouth and constipation with fesoterodine 4 mg than escalators. The decision to escalate appeared to be determined by the efficacy/tolerability responses; fesoterodine escalators demonstrated a lower sensitivity (less efficacy and fewer adverse events) before their decision to escalate. By study end (8–11 weeks after escalation decision), the efficacy and tolerability profiles were similar in escalators and non-escalators. Conclusions Data from flexible-dose studies provide strong evidence that fesoterodine provides treatment benefit to individual subjects with OAB because of its true dose–response effect. In clinical practice, it can be worthwhile to escalate to fesoterodine 8 mg in individual subjects who require additional efficacy benefit.

Efficacy and safety of phosphodieterase-5 inhibitors for the treatment of erectile dysfunction secondary to spinal cord injury

Introduction This manuscript summarizes the work of Committee 10 on neurologic bladder and bowel of the International Consultation on Incontinence in 2008–2009. As the data are very large the outcome is presented in different manuscripts. This manuscript deals with neurologic urinary incontinence. Methods Through in debt literature review all aspects of neurological urinary incontinence were studied for levels of evidence. Recommendations for diagnosis and treatment, and for future research were made. Results Pathophysiology was summarized for different levels of lesions. For epidemiology, specific diagnostics, conservative treatment and surgical treatment of neurologic urinary incontinence, levels of evidence and grades of recommendation were made following ICUD criteria. Conclusions Though data are available that advice and guide in the management of urinary incontinence in neurologic patients, not many data have a high level of evidence or permit a high grade of recommendation. More and well-structured research is needed. Neurourol. Urodynam. 29: 159–164, 2010. © 2009 Wiley-Liss, Inc.

Aims: To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment. Methods: This was a 12-week, open-label, flexible-dose study of adults with OAB (¡Ý 8 micturitions and ¡Ý 3 urgency episodes per 24 h) who had been treated with tolterodine (immediate- or extended-release) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on the subject's and physician's subjective assessment of efficacy and tolerability. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question (TSQ). Safety and tolerability were assessed. Results: Among 516 subjects treated, approximately 50% opted for dose escalation to 8 mg at week 4. Significant improvements from baseline to week 12 were observed in micturitions, urgency urinary incontinence episodes, micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h (all p < 0.0001). Approximately 80% of subjects who responded to the TSQ at week 12 reported satisfaction with treatment; 38% reported being very satisfied. Using the PPBC, 83% of subjects reported improvement at week 12 with 59% reporting improvement ¡Ý 2 points. Significant improvements from baseline (p < 0.0001) exceeding the minimally important difference (10 points) were observed in OAB-q Symptom Bother and Health-Related Quality of Life (HRQL) scales and all four HRQL domains. Dry mouth (23%) and constipation (5%) were the most common adverse events; no safety issues were identified. Conclusion: Flexible-dose fesoterodine significantly improved OAB symptoms, HRQL, and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy.

Study design: Review study. Objectives: Alternative treatments to oral phosphodiesterase type 5 inhibitors (PDE5Is) in individuals with spinal cord lesions (SCLs) and erectile dysfunction (ED). Setting: Italy. Methods: Research clinical trials (1999-2014). Results: Twelve studies were selected. One article documented that 76% of subjects reached satisfactory sexual intercourse (SI) using intracavernosal injection of vasoactive medications (papaverine and prostaglandin E1). One study regarding perineal training showed a significant increase (Po0.05) in penile tumescence in 10 individuals with preserved sacral segment. Two studies reported contrasting results on erectile function (EF) using various dosages of oral fampridine (25-40 mg). Furthermore, 95.1% of patients on fampridine 25mg experienced drawbacks. Disappointing findings were found with intraurethral alprostadil (125-1000 mu g) and sublingual apomorphine 3mg. Two studies concerning penile prosthesis reported valid SI more than 75% of the time with a mean follow-up of 11 years, although around 15% of individuals showed side effects. As for surgical treatments, 88% of males submitted to Brindley sacral anterior root stimulator after sacral dorsal rhizotomy achieved valid erection up to 8 years following the procedure. Three studies documented the impact of definitive sacral neuromodulation implant (Medtronic, Minneapolis, MN, USA) also on EF. After surgery, 20-37.5% of patients with ED recovered normal EF. Conclusions: Data are scant on the efficacy of ED treatments for SCL subjects who did not respond to PDE5Is. Further research should investigate the effects of any SCL treatments even when they are not strictly used for neurogenic sexual dysfunction.

Study design: Clinical case report with comments by colleagues from Austria, Belgium, Germany, Japan, and Poland. Objectives: To discuss challenges in the management of spinal bifida patients, who have marked kyphoscoliosis and no vascular access. Setting: Regional Spinal Injuries Centre, Southport, UK. Methods: A female patient, who was born with spina bifida, paraplegia and solitary right kidney, had undergone ileal loop urinary diversion. Renal calculi were noted in 1986. Percutaneous nephrostolithotomy was performed in 1989 and there was no residual stone fragment. However, she developed recurrence of calculi in the lower pole of the right kidney in 1991. Intravenous urography, performed in 1995, revealed right staghorn calculus and hydronephrosis. Chest X-ray showed markedly restricted lung volume due to severe kyphoscoliosis. In 2000, she was declared unsuitable for anaesthesia due to a lack of venous access and a high likelihood of difficulty in weaning off the ventilator in the postoperative period. In June 2002, she developed anuria (urine output=18 ml/24 h) due to ball-valve-type obstruction by a renal stone at the ureteropelvic junction. Urea: 14.4 mmol/l; creatinine: 236 μl/l. Ultrasound showed right hydronephrosis. Percutaneous nephrostomy was performed. Results: Following relief of urinary tract obstruction, there was postobstructive diuresis (3765 ml/24 h). However, the patient expired 19 days later due to progressive respiratory failure. Conclusion: In this spina bifida patient, who had reached the age of 35 years, severe kyphoscoliosis and lack of vascular access presented insurmountable challenges to implement the desired surgical procedure for removal of stones from a solitary kidney.

Study design: Literature review to evaluate the complications seen in patients on intermittent catheterization (IC) and intermittent self-catheterization (ISC). Objectives: To find the prevalence of most complications seen in patients on IC. To study the prevention and the treatment of these complications. Setting: An international literature review. Methods: Most relevant articles on the subject are reviewed. Conclusion: Urinary tract infection is the most frequent complication in patients performing IC. Catheterization frequency and the avoidance of bladder overfilling are amongst the most important prevention measures. Asymptomatic bacteriuria does not need to be treated with antibiotics. Long-term antibacterial prevention does seem to bear a risk of development of bacterial resistance. Previous treatment with indwelling catheters is a risk factor for chronic infection and urinary sepsis. Prostatitis is more frequently present than often thought. Epididymitis and urethritis are rare. Trauma from catheterization occurs regularly, but lasting effects are more limited. However, the prevalence of urethral strictures and false passages increases with longer use of IC. The use of hydrophilic catheters might be able to lower the urethral complication rate but additional proof through comparative studies is needed. The most important prevention measures are good education of all involved in IC, good patient compliance, the use of a proper material and the application of a good catheterization technique.

SUMMARY Overactive bladder and urgency incontinence are common and distressing conditions in older people, for which the first-line pharmacological treatment is a bladder antimuscarinic agent. Of these, oxybutynin is often recommended in guidelines, but is associated with a higher incidence of adverse drug effects, and in particular has been suggested to have deleterious cognitive effects. Despite this, guidelines often suggest oxybutynin as first-line treatment, and insurance based healthcare systems often require oxybutynin to be used as a first-line therapy and fail before reimbursement for the cost of newer anticholinergics is authorised. We reviewed the literature of bladder antimuscarinics in older adults, using the headings overactive bladder, urinary frequency, urgency, urge, oxybutynin, antimuscarinic, older, older people, and frail. In general, oxybutynin had a similar efficacy to other anticholinergic drugs, but a higher incidence of adverse drug events, in particular significant yet unnoticed cognitive impairment. We conclude that oxybutynin should not be used in frail older people. Review criteria Theinformationconsideredinthereviewwasgathered with a literature search using the headings overactive bladder, urinary frequency, urgency, urge, oxybutynin, antimuscarinic, older, older people and frail. These were manually reviewed for relevant articles, specifically those relating to overactive bladder and its treatment in older people, and to the pharmacology, efficacy and adverse effect profile of oxybutynin. Message for the clinic Although commonly prescribed and recommended in guidelines, oxybutynin is associated with significantly worse adverse effects than other, more specific antimuscarinics, and its use in the frail elderly should be avoided.

Quantitative MRI analysis correlates with surgical outcome of cervical spinal cord injury without radiological evidence of trauma

Although the aetiology of urinary incontinence can be multifactorial, in some cases weight loss could be considered as a part of the therapeutic approach for urinary incontinence in people who are overweight. The objective of this study was to review and meta-analyse the effect of non-surgical weight loss interventions on urinary incontinence in overweight women. Web of Science, PubMed, Pedro, SPORTDiscus and Cochrane were systematically searched for clinical trials that met the a priori set criteria. Data of women who participated in non-surgical weight loss interventions (diet, exercise, medication or a combination) were included in the meta-analysis. After removing duplicates, 62 articles remained for screening on title, abstract and full text. Six articles (totalling 2,352 subjects in the intervention groups) were included for meta-analysis. The mean change in urinary incontinence (reported as frequency or quantity, depending on the study) after a non-surgical weight loss intervention, expressed as standardized effect size and corrected for small sample sizes (Hedges' g), was -0.30 (95%CI = -0.47 to -0.12). This systematic review and meta-analysis shows evidence that a non-surgical weight loss intervention has the potential to improve urinary incontinence and should be considered part of standard practice in the management of urinary incontinence in overweight women.

Objective To analyse the changes in toilet training of children in Belgium in the last three generations and to seek a possible cause for the apparent increase in lower urinary tract dysfunction over that period. Patients and methods A questionnaire (25 questions) was developed and completed by 321 people who had toilet-trained 812 children. The population was divided into three groups according to the age of those who trained the children. Results There has been a major change in toilet training in the last 60 years; the age at which toilet training began has been significantly postponed. One reason for starting training, i.e. bladder control during the afternoon nap (which can probably be considered as an indication of sufficient bladder capacity) has become less important. Season (summer) has become a more important factor, as has starting school. Training by bladder drill, formerly widely used, was progressively abandoned and a more liberal attitude adopted by the youngest parents. Conclusion There seems to be good concordance between the programmes currently proposed for treating bladder dysfunction in children and the traditional bladder-training methods used by parents 60 years ago. To start bladder training when the child stays dry during the afternoon nap and using bladder drill might help to avoid permanent bladder dysfunction. The lack of formal bladder training may be responsible for an increase in lower urinary tract dysfunction.

The aim of the study was to determine the success rate, the complications, the failures and the solutions found in troublesome cases. A retrospective study was performed in three university centers in Belgium. Between March 1994 and April 1998, a quadripolar electrode and a pulse generator were implanted in 53 patients (8 men, 45 women, 43 +/- 12 years, mean follow-up 24 +/- 8 months, range 13-39 months). During the first few months, 45 (85%) of the 53 patients had an objective response. Eight late failures occurred, with a mean failure delay of 9 +/- 5 months. We performed 15 revisions in 12 patients. Major complications were pain and current-related troubles. The outcome was significantly better (P = 0.001) in post-stress incontinence surgery patients. Device-related pain was found more frequently in patients with dysuria and/or retention or perineal pain, and the test stimulation was less reliable (P = 0.025) in patients with a psychiatric history. Sacral nerve stimulation is efficient in treating patients with refractory lower urinary tract symptoms and/or perineal pain.

Prostate cancer: a hazard also to be considered in the ageing male patient with spinal cord injury

In 92 patients with spinal cord lesion, out of spinal shock, the data from a clinical neurological examination of the lumbosacral area are compared with the data from a full urodynamic investigation, including evaluation of sensation in the lower urinary tract. A significant correlation can be found between different levels of spinal cord lesion, the function of bladder neck and sphincter and the anal bulbocavernosus reflexes. Higher lesions correspond more with a reflexic lower urinary tract and somatic motor activity, lower lesions more with areflexia. With a lesion between thoracic 10 and lumbar 2 as many reflexic as areflexic lower urinary tract dysfunctions were found. The presence or absence of perineal sensation of light touch corresponded significantly with the presence or absence of sensation in the lower urinary tract. Detrusor and striated sphincter reflexia/areflexia corresponded significantly with the presence/absence of bulbocavernosus and anal reflexes. Clinical neurological examination gives useful information which acceptably corresponds with the LUT function. However to decide on a detailed individual diagnosis, clinical examination is in our opinion insufficient. Urodynamic tests are needed for a profound evaluation of the function of different parts of the lower urinary tract and their interaction.

Optimal parameters of exercise programs need to look at the interaction with oxidative stress

Challenges of today: at one side employment important for quality of life and to avoid depression; at the other side a worldwide economic crisis

Objective: To develop a web-based educational resource for health professionals responsible for the management of spinal cord injury (SCI). The resource: www.elearnSCI.org is comprised of seven learning modules, each subdivided into various submodules. Six of the seven modules address the educational needs of all disciplines involved in comprehensive SCI management. The seventh module addresses prevention of SCI. Each submodule includes an overview, activities, self-assessment questions and references. Development of the resource: Three hundred and thirty-two experts from The International Spinal Cord Society (ISCoS) and various affiliated societies from 36 countries were involved in developing the resource through 28 subcommittees. The content of each submodule was reviewed and approved by the Education and Scientific Committees of ISCoS and finally by an Editorial Committee of 23 experts. Key features: The content of the learning modules is relevant to students and to new as well as experienced SCI healthcare professionals. The content is applicable globally, has received consumer input and is available at no cost. The material is presented on a website underpinned by a sophisticated content-management system, which allows easy maintenance and ready update of all the content. The resource conforms to key principles of e-learning, including appropriateness of curriculum, engagement of learners, innovative approaches, effective learning, ease of use, inclusion, assessment, coherence, consistency, transparency, cost effectiveness and feedback. Conclusion: www.elearnSCI.org provides a cost effective way of training healthcare professionals that goes beyond the textbook and traditional face-to-face teaching. Spinal Cord (2013) 51, 176-182; doi:10.1038/sc.2012.177

Cervical spinal cord injuries without radiographic evidence of trauma: the potential for recovery of upper extremity function

Secondary health conditions in individuals with spinal cord injury: a sign of premature ageing?

Improve efficiency of spinal cord rehabilitation by reducing length of stay while maintaining or improving patient outcomes

To develop an International Spinal Cord Injury (SCI) Urinary Tract Infection (UTI) Basic Data Set presenting a standardized format for the collection and reporting of a minimal amount of information on UTIs in daily practice or research. International working group. The draft of the Data Set developed by a working group was reviewed by the Executive Committee of the International SCI Standards and Data Sets, and later by the International Spinal Cord Society (ISCoS) Scientific Committee and the American Spinal Injury Association (ASIA) Board. Relevant and interested scientific and professional (international) organizations and societies (∼40) were also invited to review the data set, and it was posted on the ISCoS and ASIA websites for 3 months to allow comments and suggestions. The ISCoS Scientific Committee, Executive Committee and ASIA Board received the data set for final review and approval. The International SCI UTI Basic Data Set includes the following variables: date of data collection, length of time of sign(s)/symptom(s), results of urine dipstick test for nitrite and leukocyte esterase, urine culture results and resistance pattern. The complete instructions for data collection and the data form itself are freely available on the website of ISCoS ( http://www.iscos.org.uk ).

The impact of early versus late surgical decompression on neurological recovery after traumatic spinal cord injury (SCI)

Good experience with clam cystoplasty is reported for 28 patients (14 female), 89% of whom had a neuropathic bladder. Prolonged conservative treatment had failed in all cases. The efficacy of the operation in terms of continence, increased bladder compliance, and bladder capacity was confirmed. Complications were common and included inability to void (70%) requiring clean intermittent catheterisation (CIC), recurrent urinary tract infection (59%) and stone formation (22%). Due to these complications, further surgery was required for 44% of the patients. Although clam enterocystoplasty is an efficient way to reconstruct a functionally disturbed urinary tract, careful patient selection is essential. Lifetime follow-up and recognition of the most frequent complications is mandatory.

Autologous incubated macrophage treatment failed to show a difference in the neurological outcome in patients with acute, complete spinal cord injury