Dataset Information

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

ABSTRACT: The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence.

SUBMITTER: Eric Jelovsek J

PROVIDER: S-EPMC4757512 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

Eric Jelovsek J J Markland Alayne D AD Whitehead William E WE Barber Matthew D MD Newman Diane K DK Rogers Rebecca G RG Dyer Keisha K Visco Anthony A Sung Vivian W VW Sutkin Gary G Meikle Susan F SF Gantz Marie G MG

Contemporary clinical trials 20150818

The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers ac ...[more]

PMID: 26291917

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Project description:BACKGROUND:Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo. METHODS:In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565. FINDINGS:Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change -1·5 points, 95% CI -3·4 to 0·4, p=0·12), biofeedback versus education (-0·7 points, -2·6 to 1·2, p=0·47), and loperamide and biofeedback versus placebo and biofeedback (-1·9 points, -4·1 to 0·3, p=0·092) or versus loperamide plus education (-1·1 points, -3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group). INTERPRETATION:In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation. FUNDING:Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health.

Project description:The aim of this study was to compare the effect of pelvic floor muscle training with surface electromyographic (sEMG) biofeedback (BF group) and Pilates exercises (P group) on the bioelectrical activity of pelvic floor muscles in women with stress urinary incontinence. The other aim aim was to compare changes in voiding diaries and scores on quality of life questionnaire against baseline values and between the groups. Women in the BF group (n = 18) participated in pelvic floor muscle training with sEMG biofeedback; the P group (n = 13) participated in basic level Pilates workouts. Both protocols were continued for eight weeks. Voiding diary, quality of life and electromyographic characteristics of the pelvic floor muscles were assessed at the three-time points: at baseline, after eight weeks' training, and at month six post-training. The sEMG activity of the pelvic floor muscles was tested during five trials in two positions. There was no marked improvement in bioelectrical activity of the pelvic floor muscles during contraction following training with sEMG biofeedback or Pilates exercises. Following eight weeks of sEMG biofeedback training, a decrease was noted in resting bioelectrical activity of pelvic floor muscles and during relaxation after sustained contraction but only in supine-lying. No such effect was observed in the Pilates group. In the BF group, the number of incontinence episodes after end of treatment (timpepoints: 1vs. 2) and at six month follow-up (timpepoints: 1vs. 3) decreased by 68.5% and 89.3%, respectively. The respective values in the P group were 78.6%, and 86.4%. The intergroup differences did not reach the level of statistical significance. As regards the quality of life, the questionnaire demonstrated that Pilates exercises had significantly better effects compared to biofeedback training both at the end of the eight-week exercise program and (p = 0.003) and at six month follow-up (p = 0.0009). The International Consultation on Incontinence Questionnaire-Short Form (ICIQ- SF) showed comparable efficacy of Pilates exercises and training with sEMG biofeedback. Intragroup improvements in micturition frequency, incontinence (leakage) episodes, and nocturia frequency were comparable. Alleviation of urinary incontinence symptoms was comparable in both groups, whereas the improvement in the quality of life was more notable in the Pilates group. The obtained results failed to demonstrate the superiority of any of the two methods regarding the bioelectrical activity of pelvic floor muscles in patients with stress urinary incontinence.

Project description:Background/aimsFecal incontinence (FI) is a prevalent condition among community-dwelling women, and has a major impact on quality of life (QoL). Research on treatments commonly used in clinical practice-Kegel exercises, biofeedback, electrostimulation, and transcutaneous neuromodulation-give discordant results and some lack methodological rigor, making scientific evidence weak. The aim is to assess the clinical efficacy of these 4 treatments on community-dwelling women with FI and their impact on severity, QoL and anorectal physiology.MethodsA randomized controlled trial was conducted on 150 females with FI assessed with anorectal manometry and endoanal ultrasonography, and pudendal nerve terminal motor latency, anal/rectal sensory-evoked-potentials, clinical severity, and QoL were determined. Patients were randomly assigned to one of the following groups: Kegel (control), biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel, treated for 3 months and re-evaluated, then followed up after 6 months.ResultsMean age was 61.09 ± 12.17. Severity of FI and QoL was significantly improved in a similar way after all treatments. The effect on physiology was treatment-specific: Kegel and electrostimulation + Kegel, increased resting pressure (P < 0.05). Squeeze pressures strongly augmented with biofeedback + Kegel, electrostimulation + Kegel and neuromodulation + Kegel (P < 0.01). Endurance of squeeze increased in biofeedback + Kegel and electrostimulation + Kegel (P < 0.01). Rectal perception threshold was reduced in the biofeedback + Kegel, electrostimulation + Kegel, and neuromodulation + Kegel (P < 0.05); anal sensory-evoked-potentials latency shortened in patients with electrostimulation + Kegel (P < 0.05).ConclusionsThe treatments for FI assessed have a strong and similar efficacy on severity and QoL but affect specific pathophysiological mechanisms. This therapeutic specificity can help to develop more efficient multimodal algorithm treatments for FI based on pathophysiological phenotypes.

Project description:Integrated exercises that mimic daily tasks are generally preferred for improving performance and the later stages of rehabilitation, but it is unknown whether integrated core exercises are better than isolated core exercises at improving muscle activation for hypertrophy. The aim of the study was to compare the electromyographic (EMG) activity in rectus abdominis, oblique externus, and erector spinae while performing three conditions of integrated core exercises (lunges) with three isolated core exercises (prone bridge, side bridge and back extension). The three conditions of lunges were: on a stable surface, unstable surface and with external resistance to the trunk using an elastic band. The external resistance was measured with a force cell and peaked at 75N. After one familiarization session, all exercises were performed in one experimental session in randomized order. The isolated core exercises were performed in 20 seconds and the time performing the five repetitions with lunges was matched (20 seconds). Significantly greater peak normalized EMG activity were observed in the isolated core exercises compared to the three integrated core exercises (P<0.001) with two exceptions. For the oblique externus, the isolated core exercise was only greater than the stable lunge. Lunges with elastic bands only demonstrated greater peak erector spinae activation compared the other lunge conditions. Comparing the mean EMG activity between the isolated and three integrated exercises, greater muscle activations were observed performing the isolated exercises (P<0.001). Unstable lunges did not increase the peak or mean core muscle activations. In conclusion, mean and peak EMG activity performing the isolated exercises were in general greater than the three condition of lunges. Based on these results, we recommend using isolated core exercises when the primary goal is to improve muscle activation and elicit hypertrophy, but integrated exercises once adequate initial hypertrophy is achieved.

Dataset Information

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

Publications

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

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