Prevention of exercise incontinence with mechanical devices. A randomized controlled trial of the NEAT expandable tip continence device. Device to promote pelvic floor muscle training for stress incontinence. The management of urinary incontinence in local authority residential homes for the elderly. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. A new pelvic muscle trainer for the treatment of urinary incontinence. Effectiveness of multidimensional exercises for the treatment of stress urinary incontinence in elderly community-dwelling Japanese women: a randomized, controlled, crossover trial. Comparative study of effects of extracorporeal magnetic innervation versus electrical stimulation for urinary incontinence after radical prostatectomy. A new intravaginal device for stress incontinence in women.
A prospective, randomized, single-blind study addressed the hypothesis that simple mechanical barriers are helpful in controlling urinary incontinence during exercise. Eighteen incontinent exercisers aged 33-73 participated in three 40-minute standardized aerobics sessions wearing either a Hodge pessary with support, a super tampon or no mechanical device. Urine loss was determined by a change in the weight of the pad worn while exercising. Statistical analysis of the log of urine loss revealed that women lost significantly less urine when exercising with either the pessary or the tampon than when exercising with no device. Thus, both devices studied are useful, nonsurgical alternatives for some women for the treatment of exercise incontinence. Urethral devices are one conservative management option for stress and mixed urinary incontinence, but there is little published data about their use. The aims of this study were to assess the safety and efficacy of a new urethral device (NEAT) and compare it with the Reliance Insert. The ease of use of both devices was then evaluated. Twenty-four women with mixed or stress urinary incontinence, patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria, were enrolled in the study. Study subjects were blinded and randomly assigned to a device group. Device efficacy was assessed by pad weighing at 0 and 4 months. Success was defined as a 50% or greater reduction in urine loss using the formula 100[(pad weight without device -pad weight with device)/pad weight with device]. Safety was evaluated using urinalysis and urine cultures. Ease of use assessment scales were also completed. Eleven patients were randomized to the Reliance Insert and 13 to the NEAT device. There were no significant differences between the two groups in age, height, weight, duration of incontinence, pad weight, leakage score, parity or quality of life score. Based on the pad weight success formula, there was no significant difference in device success between the two groups at 4 months. Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight. Previous treatment, diagnosis and hormone replacement therapy all had no relationship to device success. Leakage score data showed that subjects had a significant decrease in urine leakage when using either device. There was no statistically significant difference in ease of use between the two devices. Adverse symptoms most commonly noted were awareness of the device (62.5%), urgency (29.2%), and urethral discomfort or pain (20.8%). One urinary tract infection (UTI) was observed. The most common finding on urinalysis was trace hematuria (15.8%). Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert. Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence. The risk of UTI is low, but these devices may cause trace hematuria. Many patients with stress urinary incontinence do not have enough motivation to continue pelvic floor muscle training (PFMT) by themselves. Therefore, a device was created to support PFMT, and its effect was examined.
                Forty-six women with stress urinary incontinence were assigned to a control group or a device group in order of presentation. A pamphlet on PFMT was given to control patients, while the same pamphlet plus the device and instructions on its use were given to patients in the device group. The device had a chime that was set to sound three times a day when exercise sessions were scheduled. PFMT consisted of fast and slow pelvic floor muscle contraction exercises that were performed for 2 min and followed a rhythm set by the device.
                After 8 weeks, 20 patients from the control group and 21 patients from the device group could be evaluated. In the control group, only the quality of life (QOL) index improved significantly. In the device group, however, the daily number of incontinence episodes, the number of pads used daily, the QOL index, and the pad weight in the pad test improved significantly. Patients in the device group said that they felt obligated to perform PFMT when the chime sounded. Forty-eight percent of patients from the device group were satisfied with the outcome of PFMT, while only 15% were satisfied in the control group.
                This device may be useful to support the management of stress urinary incontinence. Urinary incontinence occurring at least once weekly was found in 32% of residents in 30 Local Authority Residential Homes for the Elderly. Incontinence was significantly commoner among female residents. One hundred and seventy-four incontinent residents were randomly selected in order to assess the effect of medical intervention (study group). A further 104 incontinent residents were selected to act as controls (control group). The vast majority of the study group showed evidence of chronic brain failure and 40% had impaired mobility. Almost half had been incontinent since admission. Urodynamic studies were required for management in only two (1.1%). Most (93%) were managed in accordance with a clinical diagnosis of an unstable bladder. There was a reduction in daytime incontinence in 40% of the study group, but this was matched by a reduction in 29% of the control group and the difference was not significant. The reduction in nocturnal incontinence in 41% of the treatment group was significantly different from 23% of the control group (P = 0.016). Urinary incontinence is a common condition caused by many factors with several treatment options.
                To compare the effectiveness of biofeedback-assisted behavioral treatment with drug treatment and a placebo control condition for the treatment of urge and mixed urinary incontinence in older community-dwelling women.
                Randomized placebo-controlled trial conducted from 1989 to 1995.
                University-based outpatient geriatric medicine clinic.
                A volunteer sample of 197 women aged 55 to 92 years with urge urinary incontinence or mixed incontinence with urge as the predominant pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory, and not have dementia.
                Subjects were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, drug treatment (with oxybutynin chloride, possible range of doses, 2.5 mg daily to 5.0 mg 3 times daily), or a placebo control condition.
                Reduction in the frequency of incontinent episodes as determined by bladder diaries, and patients' perceptions of improvement and their comfort and satisfaction with treatment.
                For all 3 treatment groups, reduction of incontinence was most pronounced early in treatment and progressed more gradually thereafter. Behavioral treatment, which yielded a mean 80.7% reduction of incontinence episodes, was significantly more effective than drug treatment (mean 68.5% reduction; P=.04) and both were more effective than the placebo control condition (mean 39.4% reduction; P<.001 and P=.009, respectively). Patient-perceived improvement was greatest for behavioral treatment (74.1% "much better" vs 50.9% and 26.9% for drug treatment and placebo, respectively). Only 14.0% of patients receiving behavioral treatment wanted to change to another treatment vs 75.5% in each of the other groups.
                Behavioral treatment is a safe and effective conservative intervention that should be made more readily available to patients as a first-line treatment for urge and mixed incontinence. To describe a new device for home treatment of urinary incontinence (UI) by comparing 3 conservative techniques and monitoring compliance and performance.
                Thirty-two patients with UI were allocated to 1 of 3 intervention groups: pelvic floor muscle exercises (PFME; n=11) alone; PFME combined with biofeedback (n=10); or PFME combined with electrical stimulation (n=11). The outcomes assessed were: changes in quality of life score (QLS), urodynamic and perineometric parameters, episodes of urine loss, subjective assessment of improvement, and actual compliance and performance with treatment.
                Increased pelvic muscle contraction strength (P<0.05), improvement in QLS (P<0.02), and fewer episodes of urine leakage were observed in all 3 groups (P<0.05). Compliance was similar among the groups (P=0.201).
                All 3 techniques were effective for home treatment of UI, with significant control of symptoms and improved quality of life. The device effectively monitored compliance and performance of exercises. To evaluate the effectiveness of pelvic floor muscle (PFM) and fitness exercises in reducing urine leakage in elderly women with stress urinary incontinence (UI).
                Randomized, crossover, follow-up trial.
                Urban community in Japan.
                Seventy women aged 70 and older who reported urine leakage one or more times per month; 35 were randomly assigned to intervention and the other 35 to control.
                The intervention group attended an exercise class aimed at enhancing PFMs and fitness. Duration of the exercise was 60 minutes per session twice a week for 3 months. After 3 months of exercise, the intervention group was followed for 1 year.
                Body mass index (BMI), urine leakage, walking speed, and muscle strength were measured at baseline, after the intervention, and at follow-up.
                In the intervention group, maximum walking speed and adductor muscle strength increased significantly after the intervention; there were no significant changes in the control group. After 3 months of exercise, 54.5% of the intervention group and 9.4% of the control group reported being continent. Within the cured group of UI, a significantly higher proportion had decreased their BMI at 3 months (P=.03) and increased walking speed at 3 (P=.04) and 12 (P=.047) months.
                Decrease in BMI and increase in walking speed may contribute to the treatment of UI, although the data do not support a positive correlation between strengthening of adductor muscle and improvement of UI, which needs more research. To perform a randomized comparative study to investigate the clinical effects of extracorporeal magnetic innervation (ExMI) and functional electrical stimulation (FES) on urinary incontinence after retropubic radical prostatectomy.
                Thirty-six patients with urinary incontinence after radical prostatectomy were randomly assigned to three groups (12 patients each in the FES, ExMI, and control groups). For FES, an anal electrode was used. Pulses of 20-Hz square waves at a 300-micros pulse duration were used for 15 minutes twice daily for 1 month. For ExMI, the Neocontrol system was used. The treatment sessions were for 20 minutes, twice a week for 2 months. The frequency of the pulse field was 10 Hz for 10 minutes, followed by a second treatment at 50 Hz for 10 minutes. For the control group, only pelvic floor muscle exercises were performed. Objective measures included bladder diaries, 24-hour pad weight testing, and a quality-of-life survey, at 1, 2, and 4 weeks and 2, 3, 4, 5, and 6 months after removing the catheter.
                The leakage weight during the 24 hours after removing the catheter was 684, 698, and 664 g for the FES, ExMI, and control groups, respectively. At 1 month, it was 72, 83, and 175 g (FES versus control, P <0.05) and at 2 months was 54, 18, and 92 g (ExMI versus control, P <0.05) in the FES, ExMI, and control groups, respectively. Finally, 6 months later, the average 24-hour leakage weight was less than 10 g in all groups. Quality-of-life measures decreased after surgery, but gradually improved over time in all groups. No complications were noted in any of the groups.
                ExMI and FES therapies offered earlier continence compared with the control group after radical prostatectomy. We consider ExMI and FES to be recommendable options for patients who want quick improvement of postoperative urinary incontinence. To compare two versions of the same type of disposable intravaginal device (the Conveen Continence Guard, CCG, and the Contrelle Continence Tampon, CCT, Coloplast a/s, Humlebaek, Denmark) for treating stress incontinence in women.
                Women with the predominant symptom of stress incontinence were recruited from four centres in Denmark, Australia and the UK. The women were assessed using a 24-h pad-test, uroflowmetry, postvoid residual urine volume and a voiding diary before treatment, and after 5 weeks using each of the two devices. Vaginal swabs and specimens of urine were sent for culture, and a questionnaire about the subjective effect and adverse events completed at each visit. In all, 94 women were recruited, of whom 62 (66%) completed the study.
                Both devices reduced the amount of leakage significantly, but the CCT reduced urine loss significantly more than the CCG. Uroflowmetry values and residual urine volume were unchanged when using the two devices. Vaginal culture showed no abnormality during the study period, and only one woman was treated for a urinary tract infection. Side-effects were few and not serious. The women found both devices easy to prepare, insert and use; two-thirds preferred the CCT to the CCG.
                The new intravaginal device (CCT) is more effective for treating stress incontinence than the currently available version (CCG), and patient acceptability of the new device seems to be superior.
The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.