Double-blind crossover study of sacral nerve stimulation for fecal incontinence. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. A randomized trial of a screening, case finding, and referral system for older veterans in primary care. Exploring the feasibility of a community-based strength training program for older people with depressive symptoms and its impact on depressive symptoms. The effects of low-frequency endo-anal electrical stimulation on faecal incontinence: a prospective study. Does treatment of constipation improve faecal incontinence in institutionalized elderly patients? Spinal cord stimulation for cancer-related low back pain. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Does an exercise and incontinence intervention save healthcare costs in a nursing home population? Effects of loperamide oxide on gastrointestinal transit time and anorectal function in patients with chronic diarrhoea and faecal incontinence.
Patients with fecal incontinence not amenable to simple repair may have to undergo major reconstructive surgery or resort to a stoma. Sacral nerve stimulation is an alternative approach that may diminish incontinence by altering sphincter and rectal motor function. This study is the first double-blind trial examining the effectiveness of this therapy.
                Two patients with passive fecal incontinence who had been implanted for nine months with a permanent sacral nerve stimulator and electrode were studied using fecal incontinence diaries, anorectal physiological tests, and quality-of-life assessments (SF-36 health survey). The trial period consisted of two two-week periods, with the stimulator turned on for two weeks and off for two weeks. The main investigator and the patients were blinded to the status of the stimulator.
                There was a dramatic difference between the number and severity of episodes of incontinence when the stimulator was turned on vs. turned off (Patient 1, 20 vs. 2 episodes; Patient 2, 4 vs. 0 episodes; off vs. on). There was an increase in squeeze pressure (Patient 1, 70 vs. 100 cm H2O; Patient 2, 60 vs. 90 cm H2O; off vs. on), with moderate increases in resting pressure and rectal threshold and urge volumes. Quality-of-life measurements showed a marked improvement prestimulation vs. nine months after permanent stimulation.
                There is a marked, unequivocal improvement in symptoms of fecal incontinence with sacral nerve stimulation shown in this double-blind crossover trial. Sacral nerve stimulation improves the quality of life in selected patients with fecal incontinence. This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence.
                Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months.
                The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of < or = 120 degrees of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 "successful" patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group.
                Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy. To test whether a system of screening, assessment, referral, and follow-up provided within primary care for high-risk older outpatients improves recognition of geriatric conditions and healthcare outcomes.
                Controlled clinical trial with 3-year follow-up; intervention versus control group allocation based on practice group assignment.
                Department of Veterans Affairs (VA) ambulatory care center.
                Seven hundred ninety-two community-dwelling patients aged 65 and older identified by postal screening survey.
                The intervention combined a structured telephone geriatric assessment by a physician assistant, individualized referrals and recommendations, selected referral to outpatient geriatric assessment, and ongoing telephone case management.
                Main outcomes were VA medical record evidence of recognition and evaluation of target geriatric conditions (depression, cognitive impairment, urinary incontinence, falls, functional impairment), functional status (Functional Status Questionnaire, FSQ), and hospitalization (VA databases and self-reported non-VA usage).
                Intervention participants were more likely to have target conditions recognized, evaluated, and referred to specialized services within 12 months of enrollment, although there were no significant differences in FSQ scores or acute hospitalization between intervention and control groups at 1, 2, or 3 years follow-up. Subgroup analyses suggested improvements in depression symptoms and functional impairment at 1-year follow-up in intervention participants with these problems at baseline, but these findings were not evident at later follow-up.
                The intervention increased recognition and evaluation of target geriatric conditions but did not improve functional status or decrease hospitalization. Innovative screening methods can identify older people in need of geriatric services, but achieving measurable improvement in functional status or hospitalization rates will likely require a more-intensive intervention than a program involving primarily unsolicited referrals and short-term consultations. Depression is a disabling, prevalent condition. Physical activity programs may assist depression management in older people, ameliorate co-morbid conditions and reduce the need for antidepressants. The UPLIFT pilot study assessed the feasibility of older depressed people attending a community-based progressive resistance training (PRT) program. The study also aimed to determine whether PRT improves depressive status in older depressed patients.
                A randomised controlled trial was conducted. People aged > or = 65 years with depressive symptoms were recruited via general practices. Following baseline assessment, subjects were randomly allocated to attend a local PRT program three times per week for 10 weeks or a brief advice control group. Follow-up assessment of depressive status, physical and psychological health, functional and quality of life status occurred post intervention and at six months.
                Three hundred and forty six people responded to the study invitation, of whom 22% had depressive symptoms (Geriatric Depression Scale, GDS-30 score > or = 11). Thirty two people entered the trial. There were no significant group differences on the GDS at follow-up. At six months there was a trend for the PRT intervention group to have lower GDS scores than the comparison group, but this finding did not reach significance (p = 0.08). More of the PRT group (57%) had a reduction in depressive symptoms post program, compared to 44% of the control group. It was not possible to discern which specific components of the program influenced its impact, but in post hoc analyses, improvement in depressive status appeared to be associated with the number of exercise sessions completed (r = -0.8, p < 0.01).
                The UPLIFT pilot study confirmed that older people with depression can be successfully recruited to a community based PRT program. The program can be offered by existing community-based facilities, enabling its ongoing implementation for the potential benefit of other older people. Faecal incontinence is a distressing problem that is often not amenable to surgical correction. Chronic low-frequency electrical stimulation of damaged axons is thought to reduce synaptic resistance, increase the size of motor units by axonal sprouting and increase the rate of conduction of the pudendal nerve. The aim of this study was to prospectively evaluate the effect of chronic low-frequency endo-anal electrical stimulation on faecal incontinence using a home-based unit and hospital-supervised therapy.
                Forty-eight patients with faecal incontinence completed a prospective randomised trial. Patients were allocated randomly to one of two groups; group 1 was exposed to endo-anal pudendal nerve stimulation daily at home with a portable home unit, group 2 attended the physiotherapy department for endo-anal electrical stimulation under supervision.
                Continence scores improved significantly after treatment in both groups (p<0.001). Both groups showed improved manometric scores, although only group 1 showed significant improvement in both resting and squeeze pressures (mean total resting pressure 184-224 mmHg, p<0.001; mean total squeeze pressure 253-337 mmHg, p<0.001). This was also reflected by an improvement in quality of life in both groups.
                Low-frequency endo-anal electrical stimulation significantly improves continence scores and quality of life in patients with faecal incontinence not amenable to surgical correction. It leads to improved manometric values when carried out on a daily basis with a portable home unit. to evaluate whether faecal incontinence can be improved by treatment of constipation in elderly patients with faecal incontinence associated with impairment of rectal emptying.
                a prospective randomized study with a 2-month follow-up.
                five long-term care units.
                206 patients with daily faecal incontinence associated with chronic rectal emptying impairments such as faecal impaction received either a single osmotic laxative (group I) or an osmotic agent along with a rectal stimulant and weekly enemas (group II).
                episodes of faecal incontinence and associated details of soiled laundry (used as indicators of the workload for caregivers). We performed periodic digital rectal examinations on group II patients to evaluate whether treatment resulted in complete and long-lasting rectal emptying. We compared data between groups and in group II between persistently constipated patients and patients with complete rectal emptying.
                the frequency of faecal incontinence did not significantly differ between the two groups. The 23 patients in group II who had complete rectal emptying had 35% fewer episodes of faecal incontinence and 42% fewer incidents of soiled laundry than the rest of the group.
                when long-lasting and complete rectal emptying is achieved by laxatives, the number of episodes of faecal incontinence as well as the workload for caregivers is reduced. At least one third of patients with cancer have pain at the time of their diagnosis. In an attempt to provide increased pain relief for patients with intractable cancer pain, unconventional agents and interventional procedures including spinal cord stimulation (SCS) have received considerable attention.
                Patients with cancer-related low back pain underwent an uneventful SCS trial with percutaneous placement of 2 temporary 8-electrode leads placed at the level of T8-T9-T10.
                After experiencing excellent pain relief during the 2-day trial, patients were subsequently implanted with permanent leads and generator with sustained pain relief at 12 months postoperation.
                Spinal cord stimulation provides an effective, alternative treatment option for select patients with cancer-related pain who have failed conservative treatment. A recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials.
                To test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.
                A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures.
                One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) (P=0.014) and Quality of Life - Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group.
                The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia. This is the first double-blind multicenter study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients.
                A total of 34 consecutive patients (31 women), median age 57 years (range, 33-73 years), underwent sacral nerve stimulation for fecal incontinence. After implantation, 27 of 34 patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. While still blinded, the patients chose the period of stimulation (ON or OFF) that they had preferred. The mode of stimulation corresponding to the selected period was continued for 3 months (final period). Outcome measures were frequency of fecal incontinence and urgency episodes, delay in postponing defecation, score severity, feeling of improvement, preference for ON or OFF, quality of life, and manometric measurements.
                In the crossover portion of the study, the self-reported frequency of fecal incontinence episodes was significantly reduced during the ON versus the OFF period (P = 0.03), and this symptomatic improvement was consistent: 1) with the patients feeling of greater improvement during the ON versus OFF period (P = 0.02); 2) with the significant preference of patients (P = 0.02) for the ON versus OFF period. In the final period of the study, the frequency of fecal incontinence episodes decreased significantly (P = 0.005) in patients with the stimulator ON. The ability to postpone defecation (P = 0.01), the score for symptom severity (P = 0.0004), and the quality of life (P < 0.05) as well as anal sphincter function significantly improved.
                The significant improvement in FI during the ON versus OFF period indicated that the clinical benefit of sacral nerve stimulation was not due to placebo. To determine whether an intervention that combines low-intensity exercise and incontinence care offsets some of its costs by reducing the incidence of selected health conditions in nursing home residents.
                Randomized, controlled trial with the incidence and costs of selected, acute conditions compared between a 6-month baseline and an 8-month intervention phase.
                Four nursing homes.
                One hundred ninety incontinent, long-stay nursing home residents.
                Low-intensity, functionally oriented exercise and incontinence care were provided every 2 hours from 8:00 a.m. to 4:00 p.m. for 5 days a week for 8 months.
                Predefined acute conditions hypothesized to be related to physical inactivity, incontinence, or immobility were abstracted from residents' medical records by blinded observers during a 6-month baseline period and throughout the 8-month intervention. Conditions included those in the dermatological, genitourinary, gastrointestinal, respiratory and cardiovascular systems; falls; pain; and psychiatric and nutritional disturbances. Costs were determined using Current Procedural Terminology Center and Medicare allowable cost reimbursement at a rate of 80%.
                The intervention group had significantly better functional outcomes than the control group (strength, mobility endurance, urinary and fecal incontinence) and a reduction of 10% in the incidence of the acute conditions, which was not significant. There were no significant differences between groups in the cost of assessing and treating these acute conditions between baseline and intervention.
                The intervention, which is consistent with federal and clinical practice guidelines, significantly improved functional outcomes but did not reduce the incidence and costs of selected acute health conditions. The cost of implementing these labor-intensive interventions for frail nursing home residents will have to be justified based on functional and quality-of-life outcomes and are unlikely to be offset by savings in medical care costs in this population. Loperamide improves anorectal function in patients with chronic diarrhoea. We wished to investigate whether the prodrug loperamide oxide has similar effects.
                Eleven patients with chronic diarrhoea and faecal incontinence participated in a randomized, placebo-controlled, double-blind, crossover study of the effects of loperamide oxide (4 mg twice daily for 1 week).
                Loperamide oxide reduced wet stool weight and improved the patients' ratings of symptoms. Mouth-to-caecum transit time was not altered, but whole-gut transit time was prolonged. There were limited effects on anorectal function, but the mean minimum basal pressure mainly contributed by the internal anal sphincter (IAS) was increased, as was the mean volume infused before leakage occurred in the saline continence test.
                Loperamide oxide is effective in the treatment of diarrhoea with faecal incontinence; normalization of colon transit time and an increase in the tone of the IAS seem to be the main determinants of efficacy.
The very limited evidence from the included studies suggests that SNS can improve continence in selected people with faecal incontinence, and reduce symptoms in selected people with constipation. However temporary, percutaneous stimulation for a two-to-three week period does not always successfully identify those for whom a permanent implant will be beneficial. Larger, good quality randomised crossover trials are needed to allow the effects of SNS for these conditions to be assessed with more certainty.