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. Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. The effectiveness of two smoking cessation programmes for use in general practice: a randomised clinical trial. The effects of patterned urge-response toileting (PURT) on urinary incontinence among nursing home residents. Does a 3-day workshop for family medicine trainees improve preventive care? A randomized control trial. A cluster randomised trial to evaluate a nutrition training programme. Investigation of mode of action of biofeedback in treatment of fecal incontinence.
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. We tested the effectiveness of preoperative biofeedback assisted behavioral training for decreasing the duration and severity of incontinence, and improving quality of life in the 6 months following radical prostatectomy.
                We performed a prospective, randomized, controlled trial comparing preoperative behavioral training to usual care. The volunteer sample included 125 men 53 to 68 years old who elected radical prostatectomy for prostate cancer. Patients were stratified according to age and tumor differentiation, and randomized to 1 preoperative session of biofeedback assisted behavioral training plus daily home exercise or a usual care control condition, consisting of simple postoperative instructions to interrupt the urinary stream. The main outcome measurements were duration of incontinence (time to continence), as derived from bladder diaries, incontinence severity (the proportion with severe/continual leakage), pad use, Incontinence Impact Questionnaire, psychological distress (Hopkins Symptom Checklist) and health related quality of life (Medical Outcomes Study Short Form Health Survey).
                Preoperative behavioral training significantly decreased time to continence (p = 0.03) and the proportion of patients with severe/continual leakage at the 6-month end point (5.9% vs 19.6%, p = 0.04). There were also significant differences between the groups for self-reported urine loss with coughing (22.0% vs 51.1%, p = 0.003), sneezing (26.0% vs 48.9%, p = 0.02) and getting up from lying down (14.0% vs 31.9%, p = 0.04). No differences were found on return to work and usual activities or quality of life measures.
                Preoperative behavioral training can hasten the recovery of urine control and decrease the severity of incontinence following radical prostatectomy. To evaluate a structured, behavioural change, smoking cessation intervention designed for use within general practice.
                Randomised controlled clinical trial.
                General practices in Newcastle, Australia.
                311 Patients identified as smokers by a screening question were enrolled in the study. Of these, 101 were assigned to a structured behavioural change programme, 104 to a simple advice programme adapted from previous research, and 106 to a control group. No significant differences were found between groups for demographic and smoking related variables before the study.
                Patients in the simple advice group received a brief statement of advice from the general practitioner as well as three pamphlets; those in the structured intervention group were given strategies which included attitude and behavioural change programmes as well as techniques to aid compliance. The amount of smoking in all groups was assessed by self reports with validation by measurement of salivary cotinine concentrations.
                Significant increase in cessation rates.
                Significant differences between controls and the structured behavioural change group were found at the one month follow up, but only for self reported abstinence. The simple advice programme did not produce any significant differences over the control group. General practitioner evaluation of the structured programme highlighted difficulties in relation to the duration of the intervention. Overall the structured programme in its present form did not appear to be an effective programme for use within general practice. To test an individualized form of habit training for urinary incontinence (UI) among long-stay cognitively and/or physically impaired elderly nursing home residents over time.
                Randomization of subjects occurred by nursing home unit. Baseline wet checks were done hourly for one 24-hour period at 3-week intervals over 12 weeks followed by 72 hours of continuous electronic monitoring to establish precise voiding patterns for each subject. The 12-week intervention period was administered by indigenous staff after they attended a 4-hour UI educational program. Subjects were followed an additional 12 weeks to determine the extent of maintenance of the intervention among staff and subjects.
                Four non-profit nursing homes; west, mid-west, east coast.
                Consent was obtained from 154 (71%) who met primary inclusion criteria. Forty-one failed the secondary inclusion criteria leaving 113 who entered the 37-week study. Eighty-eight completed the study (experimental = 51, control = 37); all were physically and/or mentally impaired, averaged age 85, and had either urge or urge/stress UI.
                UI was significantly decreased during the 3-month period (P less than 0.001). Eighty-six percent showed improvement over baseline while one-third improved 25% or more over their baseline UI rate. The control group's UI increased during the same period of time. The volume of UI among the experimental group also decreased (P less than 0.005) while the control group's UI volume increased.
                The training program was effective in reducing UI though compliance among nursing staff averaged only 70% of the prescribed toileting times. The success of this approach is similar to other recently described behavioral programs but achieved the reduction using only regular nursing staff. This individualized approach supports the recent regulatory thrust to individualize care to promote and maintain functional abilities and autonomy. To evaluate the impact on clinical behavior of a 3-day workshop designed to increase trainees' rates of smoking cessation counseling and reminders about Pap smears in routine consultations.
                Randomized control trial.
                Accredited teaching practices of the Royal Australian College of General Practitioners' Training Program.
                Thirty-four trainees and 1,500 consecutive adult patients ages 16-65 years.
                Trainees randomly allocated to the experimental group participated in a 3-day interactive workshop on disease prevention during their 13-week family medicine term. Audiotapes of consultations with adults conducted by trainees at the beginning and end of the rotation were analyzed blind to compare assessment of patients' smoking status and, for women, date of last Pap smear. A questionnaire mailed to each patient after the consultation also allowed identification of smokers and women overdue for a smear. Consultations with these patients at risk were analyzed for preventive counseling. Inter- and intrarater reliability was calculated for audiotape analysis.
                Preworkshop rates of questions about smoking were low, occurring in 22% of consultations. While trainees allocated to the experimental workshop were more likely to ask a routine question about smoking at the end of the term than those in the control group (P = 0.01), two-thirds of smokers remained undetected irrespective of trainee group and fewer than one in five were advised to stop smoking. Reminders about Pap smears did not change as a result of training and remained low in fewer than 20% of consultations. kappa values demonstrated high reliability of audiotape analysis.
                This direct measurement of clinical behavior revealed that low levels of preventive care provided by trainees are resistant to skills training without reinforcement in clinical practice. In view of the importance of prevention in routine consultations, we recommend continued evaluation of more intensive educational programs. Those withstanding rigorous evaluation could be considered for implementation in similar training contexts seeking to improve the frequency and quality of disease prevention in primary medical care. The need for training to equip primary care staff with the knowledge and skills to provide dietary advice to the public has been acknowledged. Little is known about the effectiveness of such training at improving the dietary counselling skills of multidisciplinary practice teams.
                To evaluate the effectiveness of a nutrition training programme, delivered to primary care teams by a dietitian.
                A paired-cluster randomised trial.
                Twelve general practices in Sunderland, in the United Kingdom.
                A nutrition training programme, aimed at improving the quality of dietary consultations, was developed and delivered to six primary care teams by a dietitian. Main outcome measures were patients' recall of seven key consulting behaviours. Data were collected from patients in intervention and control practices, pre- and post-intervention. Change in knowledge and attitude of practitioners was also measured.
                All 12 practices completed the trial. Data were collected from 251 patients pre-intervention and 228 patients post-intervention. Of the seven consulting behaviours targeted in the training, only the proportion of consultations where written information (diet sheets) was provided to patients was significantly higher (13% higher, 95% confidence interval [CI = 4 to 21, P = 0.004) in the intervention practices post-training. Some evidence of improved practitioner knowledge and attitude was detected.
                This evaluation of a nutrition training intervention detected only a limited impact on the behaviour, knowledge, and attitudes of primary care practitioners in dietary consultations. A study was carried out in 25 incontinent patients to evaluate some of the factors thought to be responsible for the success of retraining for fecal incontinence. Subjects were initially allocated to one of two groups; one group was trained to perceive small rectal volumes (active retraining), the other group carried out the same maneuvers but were not given any information or instruction. Active sensory retraining reduced the sensory threshold from 32 +/- 8 to 7 +/- 2 ml (P less than 0.001), corrected any sensory delay that was present (P less than 0.004), and reduced the frequency of incontinence from 5 +/- 1 to 1 +/- 1 episodes per week (P less than 0.01). Sham retraining caused a modest reduction in the sensory threshold (from 29 +/- 9 to 20 +/- 8; P less than 0.05) but did not significantly reduce the frequency of incontinence. Subsequent strength and coordination training did not significantly improve continence, although at the end of the study, 50% of patients had no incontinent episodes at all and 76% of patients had reduced the frequency of incontinence episodes by more than 75%. This improvement in continence was not associated with any change in sphincter pressures or in the continence to rectally infused saline but was associated with significant improvements in rectal sensation. The functional improvement was sustained over a period of two years in 16 of the 22 patients available for follow-up. In conclusion, the results support the use of retraining in the management of fecal incontinence and suggest that retraining may work by enhancing rectal sensitivity and instilling confidence.
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.