Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Jelovsek JE
PROVIDER: S-EPMC6708078 | biostudies-literature | 2019 Sep
REPOSITORIES: biostudies-literature
Publications
Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial.
Jelovsek J Eric JE 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 G AG Sutkin Gary G Zyczynski Halina M HM Carper Benjamin B Meikle Susan F SF Sung Vivian W VW Gantz Marie G MG
The lancet. Gastroenterology & hepatology 20190715 9
<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]
Similar Datasets
Project description: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.
| S-EPMC4757512 | biostudies-literature
Project description:AimTo determine if a biofeedback therapy that includes concentric resistance exercise for the anal sphincter muscles can improve muscle strength/function and improve AI symptoms compared to the traditional/non-resistance biofeedback therapy.BackgroundBiofeedback therapy is the current gold standard treatment for patients with anal incontinence (AI). Lack of resistance exercise biofeedback programs is a limitation in current practice.MethodsThirty-three women with AI (mean age 60 years) were randomly assigned to concentric (resistance) or isometric (non-resistance) biofeedback training. Concentric training utilized the Functional Luminal Imaging Probe to provide progressive resistance exercises based on the patient's ability to collapse the anal canal lumen. Isometric training utilized a non-collapsible 10 mm diameter probe. Both groups performed a biofeedback protocol once per week in the clinic for 12 weeks and at home daily. High definition anal manometry was used to assess anal sphincter strength; symptoms were measured using FISI and UDI-6. 3D transperineal ultrasound imaging was used to assess the anal sphincter muscle integrity.ResultsConcentric and isometric groups improved FISI and UDI-6 scores to a similar degree. Both the concentric and isometric groups showed small improvement in the anal high-pressure zone; however, there was no difference between the two groups. Ultrasound image analysis revealed significant damage to the anal sphincter muscles in both patient groups.ConclusionsConcentric resistance biofeedback training did not improve the anal sphincter muscle function or AI symptoms beyond traditional biofeedback training. Anal sphincter muscle damage may be an important factor that limits the success of biofeedback training.
| S-EPMC8712345 | biostudies-literature
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.
| S-EPMC6886793 | biostudies-literature
Project description:ObjectiveThis study aimed to describe the incidence of fecal incontinence (FI) at 6, 12, and 24 weeks postpartum; anal incontinence (AI) and fecal urgency at 24 weeks; and identify predictors of AI in women with obstetric anal sphincter injury (OASI).MethodsPrimiparous women sustaining OASIs were identified at 8 clinical sites. Third-degree OASIs were characterized using World Health Organization criteria, 3a (<50%) or 3b (>50%) tear through the sphincter. Fecal incontinence was defined as leakage of liquid/solid stool and/or mucus in the past month; AI was defined as leakage of liquid/solid stool and/or mucus and/or gas in the past month and was assessed at 6, 12, and 24 weeks postpartum using the Fecal Incontinence Severity Index. Logistic regression identified variables associated with AI.ResultsThree hundred forty-three women participated: 297 subjects sustained a third-degree OASI, 168 type 3a, 98 type 3b and 31 indeterminant; 45 had a fourth-degree OASI. Overall FI incidence at 6, 12, and 24 weeks was 7% [23/326; 95% confidence interval (CI), 4%-10%], 4% (6/145; 95% CI, 2%-9%), and 9% (13/138; 95% CI, 5%-16%), respectively. At 24 weeks, AI incidence was 24% (95% CI, 17%-32%) and fecal urgency 21% (95% CI, 15%-29%). No significant differences in FI and AI rates were noted by third-degree type or between groups with third and fourth OASI. Flatal incontinence was greater in women sustaining a fourth-degree tear (35% vs 16%, P = 0.04). White race (adjusted odds ratio, 4.64; 95% CI, 1.35-16.02) and shorter duration of second stage (adjusted odds ratio, 1.47 per 30 minute decrease; 95% CI, 1.12-1.92) were associated with AI at 24 weeks.ConclusionsOverall 24-week incidence of FI is 9% (95% CI, 5%-16%) and AI is 24% (95% CI, 17%-32%). In women with OASI, white race and shorter second-stage labor were associated with postpartum AI.Clinical trial registrationNCT01166399 (http://clinicaltrials.gov).
| S-EPMC4481184 | biostudies-literature
Project description:ObjectiveTo assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.DesignParallel group randomised controlled trial.Setting23 community and secondary care centres providing continence care in Scotland and England.Participants600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.InterventionsParticipants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.Main outcome measuresThe primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.ResultsMean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.ConclusionsAt 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.Trial registrationISRCTN57756448.
| S-EPMC7555069 | biostudies-literature
Project description:Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI. In a Pelvic Floor Disorders Network (PFDN) trial, participants were enrolled from eight PFDN clinical centers across the United States. A team of clinical and equipment experts developed biofeedback software on a novel tablet computer platform for conducting standardized anorectal manometry with separate manometric biofeedback protocols for improving anorectal muscle strength, sensation, and urge resistance. The training protocol also included education on bowel function, anal sphincter exercises, and bowel diary monitoring. Study interventionists completed online training prior to attending a centralized, standardized certification course. For the certification, expert trainers assessed the ability of the interventionists to perform the protocol components for a paid volunteer who acted as a standardized patient. Postcertification, the trainers audited interventionists during trial implementation to improve protocol adherence. Twenty-four interventionists attended the in-person training and certification, including 46% advanced practice registered nurses (11/24), 50% (12/24) physical therapists, and 4% physician assistants (1/24). Trainers performed audio audits for 88% (21/24), representing 84 audited visits. All certified interventionists met or exceeded the prespecified 80% pass rate for the audit process, with an average passing rate of 93%. A biofeedback protocol can be successfully imparted to experienced pelvic floor health care providers from various disciplines. Our process promoted high adherence to a standard protocol and is applicable to many clinical settings.
| S-EPMC5198255 | biostudies-literature
Project description:AimFaecal incontinence (FI) subtypes (urge, passive, mixed) are linked to the physiopathological mechanism of FI. Previous studies have failed to demonstrate a consistent relationship between FI subtype and anal sphincter dysfunction. Our aim was to evaluate the relationship between anal sphincter function, assessed using the new EndoFLIP® technology, and FI subtype.MethodPatients referred for FI were prospectively enrolled between October 2015 and May 2021 in a registry, and data were retrospectively examined. Each patient underwent a clinical assessment as well as three-dimensional high-resolution or water-perfused anorectal manometry, anal EndoFLIP®, and anorectal electrophysiological and endoanal ultrasound tests. The results of the investigations were compared across FI subtypes.ResultsThe cohort included 133 patients, 54 (41%) of whom met the criteria for urge FI, 40 (30%) for passive FI and 39 (29%) for mixed FI. The resting anal distensibility index (DI) at 50 ml of distension was significantly lower in patients with urge FI than in patients with passive FI (p = 0.04). At rest, a DI at 50 ml of distension ≥7.3 mm2 mmHg-1 and a DI at 40 ml of distension <1.3 mm2 mmHg-1 were associated with the passive and urge FI subtypes, respectively, with poor discriminatory power (an accuracy of 0.49 compared with 0.33 for random assignment). There were no differences in anorectal manometry, endoanal ultrasound or electrophysiological test results among the urge, passive and mixed FI subgroups (all p > 0.05).ConclusionThe anal sphincter DI using the EndoFLIP® system displayed poor predictive performance in distinguishing among FI subtypes.
| S-EPMC9795963 | biostudies-literature
Project description:The objective was to investigate the effect of delivery mode on anal incontinence 1-2 years after delivery in primiparous women with prolonged second stage of labor. This population-based cohort and questionnaire study performed in Stockholm Region, Sweden, included 1302 primiparous women with a second stage ≥ 3 h from December 1st, 2017 through November 30th, 2018. Background characteristics and outcome data were retrieved from computerized records. Questionnaires based on Wexner score were distributed 1-2 years after delivery. Risk of anal incontinence, defined as Wexner score ≥ 2, was calculated using logistic regression and presented as crude and adjusted odds ratios (OR and aOR) with 95% confidence intervals (CI). Compared with cesarean section, vacuum extraction was associated with anal incontinence (aOR 2.25, 95% CI 1.21-4.18) while spontaneous delivery was not (aOR 1.55, 95% CI 0.85-2.84). Anal incontinence was independently associated with obstetric anal sphincter injuries (aOR 2.03, 95% CI 1.17-3.5) and 2nd degree perineal tears (aOR 1.36, 95% CI 1.03-1.81) compared with no or 1st degree perineal tear. Obstetric anal sphincter injury at vacuum extraction inferred the highest risk of anal incontinence (aOR 4.06, 95% CI 1.80-9.14), compared with cesarean section. Increasing duration of the prolonged second stage did not affect the risk.
| S-EPMC9072350 | biostudies-literature
Project description:BackgroundChildbirth is one of the biggest risk factors for incontinence. Urinary and anal incontinence can cause pain and social limitations that affect social life, cohabitation, and work. There is currently no up-to-date literature study on the effect of pelvic floor muscle training with feedback from a physiotherapist, which involves verbal instructions based on vaginal and anal digital palpation, compared to treatment without feedback (e.g., recommendations for pelvic floor muscle training).AimThe objective of this systematic review was to examine the scientific evidence regarding the impact of pelvic floor muscle training (PFMT) with feedback from a physiotherapist and/or biofeedback on urinary and anal incontinence in women during the first six months following vaginal delivery, compared to treatment without feedback.MethodsThe literature search was conducted in the databases PubMed, Cochrane, and CINAHL. In addition, a manual search was conducted. The search terms consisted of MeSH terms and synonyms in the respective search block including population, intervention, and study design, as well as the terms pelvic floor and postpartum. An evaluation of each included study was conducted for methodological quality, evidence value, and clinical relevance.ResultsEight studies were included, three of which showed a significant difference between groups, in favor of the intervention group that received pelvic floor muscle training with feedback from a physiotherapist and/or biofeedback. Due to the varying results and insufficient quality for the majority of the studies, the scientific basis was considered insufficient.ConclusionThe scientific evidence for pelvic floor muscle training with feedback from a physiotherapist or biofeedback on postpartum urinary and anal incontinence compared to treatment without feedback is considered insufficient. Further research on the subject is needed. The study is registered in PROSPERO CRD42022361296.
| S-EPMC10657595 | biostudies-literature
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.
| S-EPMC7786087 | biostudies-literature