scholarly journals Effects of a disposable home electro-stimulation device (Pelviva) for the treatment of female urinary incontinence: a randomised controlled trial

2021 ◽  
Vol 304 (5) ◽  
pp. 1243-1251
Author(s):  
Jackie Oldham ◽  
Julia Herbert ◽  
Jane Garnett ◽  
Stephen A. Roberts
Keyword(s):  
Primary Care ◽  
Urinary Incontinence ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Female Urinary Incontinence ◽  
Open Label ◽  
General Medical Practitioner ◽  
Treatment As Usual ◽  
Nice Guidelines

Abstract Aims To compare current General Medical Practitioner treatment as usual (TAU) for the treatment of female urinary incontinence with a novel disposable home electro-stimulation device (Pelviva). Methods Open label, Primary Care post-market evaluation. 86 women with urinary incontinence were randomly assigned to one of two 12-week treatments: TAU or Pelviva for 30 min every other day plus TAU. Outcome measures included ICIQ-UI (primary), PISQ-IR, PGI-S / PGI-I and FSFI (secondary) at recruitment and immediately after intervention, 1-h pad test at recruitment and usage diaries throughout. Results Pelviva plus TAU produced significantly better outcome than TAU alone: 3 versus 1 point for ICIQ-UI (Difference − 1.8 95% CI: − 3.5 to − 0.1, P = 0.033). Significant differences were also observed for PGI-I at both 6 weeks (P = 0.001) and 12 weeks (P < 0.001). In the Pelviva group, 17% of women described themselves as feeling very much better and 54% a little or much better compared to 0% and 15% in the TAU. Overall PISQ-IR score reached statistical significance (P = 0.032) seemingly related to impact (P = 0.027). No other outcome measures reached statistical significance. Premature termination due to COVID-19 meant only 86 women were recruited from a sample size of 264. TAU did not reflect NICE guidelines. Conclusions This study suggests Pelviva is more successful than TAU in treating urinary incontinence in Primary Care. The study had reduced power due to early termination due to COVID-19 and suggests TAU does not follow NICE guidelines.

scholarly journals Effectiveness of a structured group intervention based on pain neuroscience education for patients with fibromyalgia in primary care: A multicentre randomized open‐label controlled trial

2021 ◽  
Author(s):  
María Jesús Barrenengoa‐Cuadra ◽  
María Muñoa‐Capron‐Manieux ◽  
Marian Fernández‐Luco ◽  
Luis Ángel Angón‐Puras ◽  
Ana J. Romón‐Gómez ◽  
...  
Keyword(s):  
Primary Care ◽  
Group Intervention ◽  
Controlled Trial ◽  
Open Label ◽  
Neuroscience Education

scholarly journals Physical exercise and internet-based cognitive–behavioural therapy in the treatment of depression: Randomised controlled trial

2015 ◽  
Vol 207 (3) ◽  
pp. 227-234 ◽  
Author(s):  
Mats Hallgren ◽  
Martin Kraepelien ◽  
Agneta öjehagen ◽  
Nils Lindefors ◽  
Zangin Zeebari ◽  
...  
Keyword(s):  
Physical Exercise ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Medical Practitioner ◽  
Work Capacity ◽  
Behavioural Therapy ◽  
General Medical Practitioner ◽  
Treatment As Usual ◽  
Moderate Depression ◽  
Cognitive Behavioural

BackgroundDepression is common and tends to be recurrent. Alternative treatments are needed that are non-stigmatising, accessible and can be prescribed by general medical practitioners.AimsTo compare the effectiveness of three interventions for depression: physical exercise, internet-based cognitive–behavioural therapy (ICBT) and treatment as usual (TAU). A secondary aim was to assess changes in self-rated work capacity.MethodA total of 946 patients diagnosed with mild to moderate depression were recruited through primary healthcare centres across Sweden and randomly assigned to one of three 12-week interventions (trail registry: KCTR study ID: KT20110063). Patients were reassessed at 3 months (response rate 78%).ResultsPatients in the exercise and ICBT groups reported larger improvements in depressive symptoms compared with TAU. Work capacity improved over time in all three groups (no significant differences).ConclusionsExercise and ICBT were more effective than TAU by a general medical practitioner, and both represent promising non-stigmatising treatment alternatives for patients with mild to moderate depression.

scholarly journals Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e021783 ◽  
Author(s):  
Shan Chen ◽  
Siyou Wang ◽  
Lihua Xuan ◽  
Hanti Lu ◽  
Zhikai Hu ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Randomised Controlled Trial ◽  
Medical Care ◽  
Outcome Measures ◽  
Pudendal Nerve ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Routine Medical Care ◽  
Randomised Controlled

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

scholarly journals The efficacy of iCBT added to treatment as usual for alcohol dependent patients in Primary Care: study protocol for a randomized controlled trial.

2019 ◽  
Author(s):  
Karin Hyland ◽  
Anders Hammarberg ◽  
Erik Hedman-Lagerlöf ◽  
Magnus Johansson ◽  
Sven Andreasson
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Alcohol Dependence ◽  
Controlled Trial ◽  
Alcohol Problems ◽  
Primary Study ◽  
Mixed Effect ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Alcohol Dependent

Abstract Introduction Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. General practitioners (GP) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence. Methods This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. 260 adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy drinking days. Secondary outcomes include alcohol related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models. Discussion Internet based interventions are attractive to and have been shown to reach people with alcohol problems. Yet there are no studies investigating the efficacy of internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short term and long-term public health costs. Trial registration: ISRCTN69957414. Retrospectively registered 07/06/2018. http://www.isrctn.com/ISRCTN69957414

scholarly journals “VelaMente?!” - Sailin in a Crew to Improve Self-Efficacy in People with Psychosocial Disabilities: A Randomized Controlled Trial

2017 ◽  
Vol 13 (1) ◽  
pp. 200-212 ◽  
Author(s):  
Federica Sancassiani ◽  
Alessio Cocco ◽  
Giulia Cossu ◽  
Stefano Lorrai ◽  
Giuseppina Trincas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sense Of Coherence ◽  
Self Efficacy ◽  
Longitudinal Research ◽  
Short Form ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Waiting List ◽  
Treatment As Usual

Introduction:It has been proposed that sailing can improve quality of life, personal and social skills of people with severe psychosocial disabilities. This study aimed to assess the efficacy of a psychosocial rehabilitative intervention focused on sailing on quality of life, self-efficacy and sense of coherence in people with severe psychosocial disabilities.Methods:The study was a randomized, with parallel groups, waiting-list controlled trial. Participants were 51 people with severe psychosocial disabilities. The intervention was a structured course to learn sailing in a crew lasting three months. A randomized group began the sailing course immediately after a pre-treatment assessment; the waitlist group began the sailing course after a three months period of treatments as usual. Participants were assessed before and after the sailing course, or the waiting list period, on the General Self-Efficacy scale (GSES), Sense Of Coherence scale (SOC) and Health Survey-short form (SF-12).Results:Self-efficacy significantly increased after the sailing course and decreased after treatment as usual (p=0.015). Sense of coherence and the levels of quality of life tended to improve after the sailing course, albeit below levels of statistical significance.Conclusion:When compared to more traditional psychosocial rehabilitative activities, an intervention focused on sailing in a crew positively impacts the sense of coherence and the levels of quality of life and significantly improves self-efficacy of people with severe psychosocial disabilities. Further longitudinal research is required.

scholarly journals Cognitive–behavioural therapy for anxiety in dementia: pilot randomised controlled trial

2015 ◽  
Vol 206 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Aimee Spector ◽  
Georgina Charlesworth ◽  
Michael King ◽  
Miles Lattimer ◽  
Susan Sadek ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Pilot Randomised Controlled Trial ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Effective Treatments

BackgroundAnxiety is common and problematic in dementia, yet there is a lack of effective treatments.AimsTo develop a cognitive–behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial.MethodA ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n= 25) or TAU (n= 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months.ResultsAt 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (–3.10, 95% CI −6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (–5.37, 95% CI −9.50 to −1.25). Improvements remained significant at 6 months. CBT was cost neutral.ConclusionsCBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.

scholarly journals The efficacy of iCBT added to treatment as usual for alcohol dependent patients in Primary Care: study protocol for a randomized controlled trial.

2019 ◽  
Author(s):  
Karin Hyland ◽  
Anders Hammarberg ◽  
Erik Hedman-Lagerlöf ◽  
Magnus Johansson ◽  
Sven Andreasson
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Alcohol Dependence ◽  
Controlled Trial ◽  
Alcohol Problems ◽  
Primary Study ◽  
Mixed Effect ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Alcohol Dependent

Abstract Introduction Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. General practitioners (GP) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence. Methods This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. 260 adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy drinking days. Secondary outcomes include alcohol related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models. Discussion Internet based interventions are attractive to and have been shown to reach people with alcohol problems. Yet there are no studies investigating the efficacy of internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short term and long-term public health costs. Trial registration: ISRCTN69957414. Retrospectively registered 07/06/2018. http://www.isrctn.com/ISRCTN69957414

scholarly journals Cost-effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in general practice: A pragmatic randomised controlled trial over 12 months

2021 ◽  
Author(s):  
Anne Loohuis ◽  
Henk van der Worp ◽  
Nienke Wessels ◽  
Janny Dekker ◽  
Marijke Slieker-ten Hove ◽  
...  
Keyword(s):  
Primary Care ◽  
Urinary Incontinence ◽  
Cost Effectiveness ◽  
Mobile Apps ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Life Years ◽  
Randomised Controlled

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care. Design: A pragmatic, randomised controlled, superiority trial. Setting: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. Methods: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main outcome measures: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%CI: -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).

scholarly journals Pilot Randomized Controlled Trial of the WHO Caregiver Skills Training in Public Health Services in Italy

2021 ◽  
Author(s):  
Erica Salomone ◽  
Michele Settanni ◽  
Helen McConachie ◽  
Katharine Suma ◽  
Federica Ferrara ◽  
...  
Keyword(s):  
Public Health ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Skills Training ◽  
Autism Severity ◽  
Public Health Services ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Joint Engagement ◽  
Intention To Treat

AbstractParents of children with ASD (N = 86; mean age 44.8 months; 67 boys) were randomized to either WHO Caregiver Skills Training (CST) delivered in public health settings in Italy or enhanced treatment-as-usual. Primary blinded outcomes were 3-months post-intervention change scores of autism severity and engagement during caregiver-child interaction. CST was highly acceptable to caregivers and feasibly delivered by trained local clinicians. Intention-to-treat analysis showed a large and significant effect on parent skills supporting joint engagement and a smaller significant effect on flow of interaction. Expected changes in child autism severity and joint engagement did not meet statistical significance. Analysis of secondary outcomes showed a significant effect on parenting stress, self-efficacy, and child gestures. Strategies to improve the effectiveness of CST are discussed.

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