Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL).Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577.The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC).Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate.National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).
Background Urinary incontinence is prevalent in nursing and residential care homes, and has a profound impact on residents’ dignity and quality of life. Treatment options are limited in these care contexts and care homes predominantly use absorbent pads to contain incontinence, rather than actively treat it. Transcutaneous posterior tibial nerve stimulation is a non-invasive, safe, low-cost intervention that is effective in reducing urinary incontinence in adults. Objective To determine the clinical effectiveness of transcutaneous posterior tibial nerve stimulation to treat urinary incontinence in care home residents and to determine the associated costs of the treatment. Design A multicentre, pragmatic, participant and outcome assessor-blind, randomised placebo-controlled trial. Setting A total of 37 UK residential and nursing care homes. Participants Care home residents with at least weekly urinary incontinence that is contained using absorbent pads and who are able to use a toilet/toilet aid with or without assistance. Interventions Residents were randomised (1 : 1) to receive 12 30-minute sessions of transcutaneous posterior tibial nerve stimulation or sham stimulation over a 6-week period. Main outcome measures Primary outcome – change in volume of urine leaked over a 24-hour period at 6 weeks. Secondary outcomes – number of pads used, Perception of Bladder Condition, toileting skills, quality of life and resource use. Results A total of 408 residents were randomised (transcutaneous posterior tibial nerve stimulation, n = 197; sham stimulation, n = 209); two exclusions occurred post randomisation. Primary outcome data were available for 345 (85%) residents (transcutaneous posterior tibial nerve stimulation, n = 167; sham stimulation, n = 178). Adherence to the intervention protocol was as follows: 78% of the transcutaneous posterior tibial nerve stimulation group and 71% of the sham group received the correct stimulation. Primary intention-to-treat adjusted analysis indicated a mean change of –5 ml (standard deviation 362 ml) urine leakage from baseline in the transcutaneous posterior tibial nerve stimulation group and –66 ml (standard deviation 394 ml) urine leakage in the sham group, which was a statistically significant, but not clinically important, between-group difference of 68-ml urine leakage (95% confidence interval 0 to 136 ml; p = 0.05) in favour of the sham group. Sensitivity analysis supported the primary analysis. No meaningful differences were detected in any of the secondary outcomes. No serious adverse events related to transcutaneous posterior tibial nerve stimulation were reported. Economic evaluation assessed the resources used. The training and support costs for the staff to deliver the intervention were estimated at £121.03 per staff member. Estimated costs for delivery of transcutaneous posterior tibial nerve stimulation during the trial were £81.20 per participant. No significant difference was found between participants’ scores over time, or between transcutaneous posterior tibial nerve stimulation and sham groups at any time point, for resident or proxy quality-of-life measures. Conclusions The ELECTRIC (ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes) trial showed, in the care home context (with a high proportion of residents with poor cognitive capacity and limited independent mobility), that transcutaneous posterior tibial nerve stimulation was not effective in reducing urinary incontinence. No economic case for transcutaneous posterior tibial nerve stimulation was made by the cost–consequences analysis; however, the positive reception of learning about urinary incontinence for care home staff supports a case for routine education in this care context. Limitations Completing 24-hour pad collections was challenging for care home staff, resulting in some missing primary outcome data. Future work Research should investigate transcutaneous posterior tibial nerve stimulation in residents with urgency urinary incontinence to determine whether or not targeted stimulation is effective. Research should evaluate the effects of continence training for staff on continence care in care homes. Trial registration Current Controlled Trials ISRCTN98415244 and ClinicalTrials.gov NCT03248362. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 41. See the NIHR Journals Library website for further project information.
Background Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. Provision of pelvic floor muscle training for prolapse has continued to vary across the UK, with limited availability of specialist physiotherapists to deliver it. Objectives This project aimed to study the implementation and outcomes of different models of delivery to increase the service provision of pelvic floor muscle training, and to follow up treatment outcomes for the original trial participants. Design A realist evaluation of pelvic floor muscle training implementation conducted within three full case study sites and two partial case study sites; an observational prospective cohort study comparing patient-reported outcomes pre and post intervention in all five sites; and a long-term follow-up study linking previous trial participants to routine NHS hospital data. Setting The setting for the realist evaluation was pelvic floor muscle training service delivery models in three NHS sites. The setting for the patient-reported outcome measures study was pelvic floor muscle training services in five NHS sites. Methods Realist evaluation qualitative data were collected at four time points in three case study sites to understand the implementation models, uptake, adherence and impact. Interviews involved service managers/leads, consultants, staff delivering pelvic floor muscle training and women receiving pelvic floor muscle training. Main outcomes measures Patient-reported outcomes were collected at baseline and at 6 and 12 months across five sites, including the Pelvic Organ Prolapse Symptom Score, health-related quality of life (measured using the EuroQol-5 Dimensions, five-level version, questionnaire), prolapse severity (measured using the Pelvic Organ Prolapse Quantification System), urinary incontinence (measured using International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) and need for further treatment. Results A total of 102 women were recruited to the patient-reported outcome measures cohort study (target, n = 120), and 65 women had matched baseline and 6-month Pelvic Organ Prolapse Symptom Scores. The mean Pelvic Organ Prolapse Symptom Score was 10.18 (standard deviation 5.63) at baseline and 6.98 (standard deviation 5.23) at 6 months, representing a statistically significant and clinically meaningful difference. There was no statistically significant difference between the outcomes obtained from delivery by specialist physiotherapists and the outcomes obtained from delivery by other health-care professionals (mean change in Pelvic Organ Prolapse Symptom Score: –3.95 vs. –2.81, respectively). Services delivered using higher-band physiotherapists only were more costly than services delivered using other staff mixes. The effect of the original pelvic floor muscle training intervention, over a post-intervention period of > 10 years, was a reduction in the odds of any treatment during follow-up (odds ratio 0.61, 95% confidence interval 0.37 to 0.99). The realist evaluation revealed stark differences in implementation. The site with a specialist physiotherapy service resisted change because of perceived threats to the specialist role and concerns about care quality. Pelvic floor muscle training delivery by other health-care staff was easier when there was a lack of any existing specialist service; staff had prior training and interest in pelvic health; staff had support, autonomy, time and resources to deliver pelvic floor muscle training as part of their core role; and surrounding services supported a flow of pelvic floor muscle training referrals. Limitations The number of available matched pre and post outcomes for women and the lack of Pelvic Organ Prolapse Quantification System examinations were limitations of this study. Conclusions It is possible to train different staff to effectively deliver pelvic floor muscle training to women. Women’s self-reported outcomes significantly improved across all service models. Training should be adequately tailored to differential skill mix needs. Future work Future work should include further implementation of pelvic floor muscle training and should include pre- and post-outcome data collection using the Pelvic Organ Prolapse Symptom Score. Study registration This study is registered as Research Registry 4919. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research ; Vol. 8, No. 47. See the NIHR Journals Library website for further project information.
The pelvic floor muscles (PFMs) are the layer of muscles that support the pelvic organs and play an important role in continence. Weakened PFMs will not fully support the internal organs, which can lead to difficulties controlling the release of urine, faeces or flatus and can cause prolapse to occur. Pregnancy and vaginal delivery are a recognised cause of PFM weakness; however, it has been shown that PFM exercises, if carried out correctly and routinely, can reduce the severity of symptoms. Midwives need to be pro-active in teaching PFM exercises and identifying women who may need to be referred for more specialist treatment. We describe an initiative to support midwives with these tasks.
OBJECTIVE To assess the degree of adherence to the current National Institute for Health and Clinical Excellence (NICE) guidelines on the management of urinary incontinence (UI) in women.Retrospective survey of consecutive female inpatients and outpatients with UI as part of a national audit.NHS hospital and primary care (PC) trusts.Twenty-five women <65 years old and 25 women ≥ 65 years old from each participating site.All NHS trusts in England, Wales and Northern Ireland were eligible to participate. A web-based data collection form aligned to the NICE guidelines was constructed for the study. All data submitted to the audit were anonymous and access to the web-tool was password-protected for confidentiality.Data were returned by 128 acute and 75 PC trusts on 7846 women. No diagnosis was documented in 6.8% (153/2254) of younger and 28% (571/2011) of older women in hospitals (P < 0.001), and by 8.6% (123/1435) of younger and 21% (380/1786) of older women in PC trusts. In hospitals, 26% (396/1524) of younger women and 15% (182/1231) of older women (P < 0.001) and in PC trusts 8.2% (77/934) of younger and 4.7% (46/975) of older women underwent multichannel cystometry before conservative therapy. Documentation of discussion of causes and treatment of UI occurred in 76% (1717/2254) of younger and 44% (884/2011) of older women in hospitals (P < 0.001) and in 75% (1080/1435) of younger and 53% (948/1786) of older women in PC trusts (P < 0.001). CONCLUSION Older women are less likely to receive NICE compliant management. Adherence varies according to recommendation. There needs to be concentration on evidence-based community provision of care by competent and interested clinicians before the aims of the NICE guidelines are met.
Pelvic floor muscles (PFM) are the layer of muscles that support the pelvic organs and span the bottom of the pelvis. Weakened PFM mean the internal organs are not fully supported and can lead to difficulties controlling the release of urine, faeces or flatus. Pregnancy and vaginal birth are a recognised cause of PFM weakness; however it has been shown that PFM exercises, if carried out correctly and routinely, can reduce the severity of symptoms. Midwives need to be pro-active in teaching PFM exercises and identifying women who may need to be referred on for more specialist treatment.
Aims of study: To investigate women’s experiences of electromyography (EMG) biofeedback pelvic floor muscle training (PFMT) and PFMT alone for stress or mixed urinary incontinence (UI) to explain the contextual factors that influence intervention adherence and outcome within a randomised controlled trial. Study design, materials and methods: The study design was a two-tailed, longitudinal, qualitative case study (1) carried out in parallel to a randomised controlled trial (2). The ‘tails’ were the biofeedback PFMT group and PFMT alone group. Following ethical approval, purposive maximum variation sampling (based on difference in treatment centre, UI type, and therapist type) was used to invite a subsample of women, who had consented to the trial, to take part in the case study. Interested women were sent written information about, and asked to consent to, the case study specifically. The data from each recruited women formed one case. Women were interviewed at baseline, six, 12 and 24 months after randomisation. Interviews were semi-structured, digitally recorded and transcribed. Where possible, baseline and six month interviews were face to face and either at the participant’s home or in the clinic, and 12 and 24 month interviews were by telephone. Interviews explored women’s experiences of the social contexts within which they experienced UI, the intervention they received, adherence and outcome. Data analysis principally followed case study analytic traditions (1) whereby all data from a case were analysed and findings collected together to form a case summary with a focus on understanding a woman’s experience of UI, intervention, adherence and outcome and how these factors interacted. Case summaries within a ‘tail’ were collated, the cases compared, and the two tails were then compared to one another. Results: Sample: Forty women, 20 per group, were recruited as planned; 24 had data at all four time points (10 biofeedback PFMT and 14 PFMT alone), with 2856 minutes of interview data recorded. There was a wide age range in both groups (20 to 76 years). Eleven women had stress UI and 29 Mixed UI with similar proportions in the groups. Six women were treated in community clinics, 16 in University hospitals and 18 in District General Hospitals with similar proportions in the groups. Most women were treated by specialist women’s health physiotherapists (n=36) and four by continence nurses.
Abstract Background : Neurogenic lower urinary tract dysfunction is an abnormality in the presence of underlying neurologic disease. A recent systematic review and meta-analysis demonstrated that storage phase symptoms are the predominant symptoms among people with multiple sclerosis (PwMS). Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment for bladder storage symptoms; however, the potential efficacy of stimulation among PwMS is based on a small number of studies with the absence of high-quality evidence. The aim of this study was to evaluate the feasibility, acceptability, and safety of TTNS in PwMS using an affordable transcutaneous electrical nerve stimulation (TENS) unit. Methods : A total of 23 participants with MS enrolled in the study. The primary outcomes included recruitment/retention rate, completion of the outcomes and the intervention, adherence to the protocol, adverse events, and acceptability of the intervention. The primary outcomes were assessed using diaries and satisfaction questionnaire. The secondary outcomes included changes in urinary symptoms and quality of life assessed using a set of validated outcome measures including 3- day bladder diary, PPIUS, ICIQ-OAB, and KHQ at baseline and post-intervention. Results : 20 participants completed the study. Three participants (13.04%) withdrew. All 20 participants completed the 6-week intervention and all the outcome measures (100%), with no reported adverse events. Participants were satisfied and found the unit acceptable. 3-day bladder diary showed changes in urinary frequency from a daily median of 10 times to 8 times and daily median urgency changed from 6 times at baseline to 2 times post-intervention. PPIUS showed changes in daily median sever urgency from 3 points (IQR=4) to 1 point (IQR=1) post-intervention. ICIQ-OAB total scores changed from 8 points (IQR=2.25) to 4 points (IQR=2.5) post-intervention. Median and mean scores of KHQ showed a clinical meaningful change of QoL in part-two and part-three of the questionnaire. Conclusions : TTNS is feasible, safe, and acceptable for PwMS. Changes of urinary symptoms scores and QoL post-intervention suggested improvements. Future implications need to consider the treatment protocol including frequency of treatment sessions, duration of treatment, and the electrical stimulation parameters as well as the outcome measures followed in the current study for the implementation of the future pilot RCT. Trial registration: ClinicalTrials.gov (NCT04528784). Registered 27 August 2020, https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4
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