Dataset Information

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study.

ABSTRACT:

Background

Fecal incontinence (FI) is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem which affects about 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to this treatment regime. Two physiotherapy interventions, rectal balloon training (RBT) and pelvic floor muscle training (PFMT) are widely used in the management of FI. However, their effectiveness remains uncertain since well-designed trials on the effectiveness of RBT and PFMT versus PFMT alone in FI have never been published.

Methods/design

A two-armed randomized controlled clinical trial will be conducted. One hundred and six patients are randomized to receive either PFMT combined with RBT or PFMT alone. Physicians in the University Hospital Maastricht include eligible participants. Inclusion criteria are (1) adults (aged > or = 18 years), (2) with fecal incontinence complaints due to different etiologies persisting for at least six months, (3) having a Vaizey incontinence score of at least 12, (4) and failure of conservative treatment (including dietary adaptations and pharmacological agents). Baseline measurements consist of the Vaizey incontinence score, medical history, physical examination, medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, anal endosonography, defecography, symptom diary, Fecal Incontinence Quality of Life scale (FIQL) and the PREFAB-score. Follow-up measurements are scheduled at three, six and 12 months after inclusion. Skilled and registered physiotherapists experienced in women's health perform physiotherapy treatment. Twelve sessions are administered during three months according to a standardized protocol.

Discussion

This section discusses the decision to publish a trial protocol, the actions taken to minimize bias and confounding in the design, explains the choice for two treatment groups, discusses the secondary goals of this study and indicates the impact of this trial on clinical practice.

Trial registration

The Netherlands Trial Register ISRCTN78640169.

SUBMITTER: Bols EM

PROVIDER: S-EPMC2234416 | biostudies-literature | 2007 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study.

Bols Esther M J EM Berghmans Bary C M BC Hendriks Erik J M EJ de Bie Rob A RA Melenhorst Jarno J van Gemert Wim G WG Baeten Cor G M I CG

BMC public health 20071220

<h4>Background</h4>Fecal incontinence (FI) is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem which affects about 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to t ...[more]

PMID: 18096041

Similar Datasets

Project description:Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT.The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages.Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence-care accessibility and warrant a change in clinical practice.ClinicalTrials.gov, NCT02039830 . Registered on 12 December 2013; Study protocol version 2; 21 November 2013.

Project description:BackgroundFecal incontinence has a high prevalence in the older population, which cannot be explained by comorbidity or the anatomical or psychological changes of aging alone. Fecal incontinence leads to a high economic burden to the healthcare system and is an important cause of institutionalization. In addition, fecal incontinence is associated with shame, social isolation and reduced quality of life. The importance of identifying treatable causes in the frail elderly is strongly emphasized. It is recommended that an assessment of fecal incontinence should be implemented as part of an evaluation of older patients. Although there is a substantial evidence base to guide choice of implementation activities targeting healthcare professionals, little implementation research has focused on the care of older people nor involved care processes or care personnel. This study is based on the assumption that fecal incontinence among nursing home patients can be prevented, cured or ameliorated by offering care staff knowledge of best practice through a multifaceted educational program. The primary objective is to test the hypothesis that a multifaceted educational program for nursing home care staff on assessment and treatment of fecal incontinence reduces patients' frequency of fecal incontinence.Methods/designThe study is a two-armed, parallel cluster-randomized controlled trial. Primary outcome is the frequency of fecal incontinence among patients. Sample size calculations resulted in a need for a total sample of 240 patients. Twenty nursing home units in one city in Norway will be recruited and allocated to intervention or control by an independent statistician using computer-generated tables. The intervention is a multifaceted educational program. Units in the control arm will provide care as usual. The intervention period is 3 months. Data will be collected at baseline, 3, and 6 months. Data will be analyzed using mixed effect models with the cluster treated as a random effect.DiscussionThis study is the first randomized controlled trial specifically focusing on this neglected area. The result of the study will give evidence for best practice for continence care in nursing homes, and organizational advice concerning implementation strategies.Trial registrationClinicalTrials.gov: NCT02183740 , registered June 2014.

Project description:BackgroundUrinary incontinence (UI) affects up to 40% of adult women within the UK, and pelvic floor muscle training can be effective as a treatment. The prevalence of UI is higher in athletic women than in their sedentary counterparts, but there is little research into reasons for this or into treatment within this population.The aim of this study is to investigate the feasibility of conducting a future randomised controlled trial of physiotherapeutic management of UI in athletic women.MethodsThis is a mixed methods study with three distinct but related phases.Phase 1: Semi-structured interviews with health care professionals in the community will explore current management practices of UI in women and particularly in female athletes in order to inform the control arm of a future study. It will also establish community health care professionals' understanding of pelvic health physiotherapy.Phase 2: Athletic and regularly exercising women recruited directly from gyms and sports clubs will undergo a course of physiotherapy to manage UI. This will establish study recruitment, eligibility, consent, attendance, attrition, and data completion rates. It will provide information regarding appropriate clinical venues and outcome measures to use for this patient group.Phase 3: Semi-structured interviews with purposefully selected participants from phase 2 will investigate participant satisfaction with recruitment procedures, the intervention, outcome measures and the venues. Further, we will collect data regarding the use of a smartphone 'app' for adherence and monitoring of home exercises and participants' beliefs around randomisation in a future study. We will explore the impact of UI on life and sport in more detail.DiscussionThis study will establish the ease and acceptability of recruiting athletic women directly from gyms and sports clubs and identify attrition rates. It will also explore the acceptability of the intervention, clinical venues and outcome measures. Data collected will be used to inform a future randomised controlled trial.Trial registrationNCT03986411 (clinicaltrials.gov). Registered on 14 June 2019.

Dataset Information

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study.

Background

Methods/design

Discussion

Trial registration

Publications

A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets