A phase II exploratory cluster randomized controlled trial of a group mobility training and staff education intervention to promote urinary continence in UK care homes. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial. Randomised controlled trial of biofeedback training in persistent encopresis with anismus.
To assess feasibility, acceptability and potential efficacy of group exercise and staff education intervention to promote continence in older people residing in care homes. To establish measures and information to inform a larger trial.
                Phase II pilot exploratory cluster randomized controlled trial.
                Six purposely selected care homes in the West Midlands, UK.
                Thirty-four care home residents (mean age 86, 29 female), 23 with cognitive impairments.
                Physiotherapy-led group exercise and staff continence and mobility facilitation training.
                Reported continence status, Rivermead Mobility Index. Feasibility was assessed by uptake and compliance, and acceptability by verbal feedback. A staff knowledge questionnaire was used.
                Thirty-three residents, cluster sizes from 3 to 7. The number of residents agreeing with the statement 'Do you ever leak any urine when you don't mean to?' in the intervention group decreased from 12/17 at baseline to 7/17 at six weeks in the intervention group and increased from 9/16 at baseline to 9/15 at six weeks. The Rivermead Mobility Index scores were better in the intervention group (n=17; baseline: 6.1, six weeks: 6.2) compared with controls (n=16; baseline: 5.9, six weeks: 4.75). The intervention was feasible, well received and had good compliance.
                Group mobility training and staff education to promote continence is feasible and acceptable for use with care home residents, including those with cognitive impairment. Pelvic floor electrical stimulation (PFES) has been shown to be effective for stress incontinence. However, its role in a multicomponent behavioral training program has not been defined.
                To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence.
                Prospective randomized controlled trial conducted from October 1, 1995, through May 1, 2001, at a university-based outpatient continence clinic in the United States.
                Volunteer sample of 200 ambulatory, nondemented, community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern; stratified by race, type of incontinence (stress only vs mixed), and severity (frequency of episodes).
                Patients were randomly assigned to 8 weeks (4 visits) of behavioral training, 8 weeks (4 visits) of the behavioral training plus home PFES, or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition).
                Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries. Secondary outcomes were patient satisfaction and changes in quality of life.
                Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6% with behavioral training, 71.9% with behavioral training plus PFES, and 52.5% with the self-help booklet (P =.005). In comparison with the self-help booklet, behavioral training (P =.02) and behavioral training plus PFES (P =.002) were significantly more effective, but they were not significantly different from each other (P =.60). The PFES group had significantly better patient self-perception of outcome (P<.001) and satisfaction with progress (P =.02). Significant improvements were seen across all 3 groups on the Incontinence Impact Questionnaire but with no between-group differences.
                Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence. A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs. Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction.
                A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up.
                Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, -24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, -46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, -75% to -1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different between the BFT and control groups, but there was a significant improvement in CBCL school scale scores in the BFT group, and this improvement was significantly greater than that seen in the control group.
                The result of this study, together with those reported in other controlled trials, argues against using biofeedback training in children with encopresis.
The features of habit retraining programmes vary. Adherence to the protocol appears to be problematic for carers. The evidence from the four reviewed trials is too limited to judge whether or not there are improvements in continence that would make investment in habit-retraining programmes worthwhile.