Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Women's views about a free breast pump service: Online survey informing intervention development.

Improving breastfeeding outcomes is a global priority; however, in the United Kingdom, continuation of breastfeeding remains low. Growing empirical evidence suggests a free breast pump service might be an acceptable and feasible incentive intervention to improve breastfeeding outcomes and reduce heath inequalities. To inform intervention development, we conducted an online survey with women recruited via social media using snowball sampling. Data were analysed descriptively (closed questions) with qualitative thematic analysis (free text). The survey was completed by 666 women, most of whom had recently breastfed and used a breast pump. Participants agreed that free pump hire (rental/loan; 567 women; 85.1%) or a free pump to keep (408; 61.3%) should be provided. Free text comments provided by 408 women (free pump) and 309 women (free hire) highlighted potential benefits: helping women to continue breastfeeding; express milk; overcome difficulties; and pump choice. Concerns are possible effect on breast milk supply, reduced breastfeeding, pumps replacing good support for breastfeeding, and pump hire hygiene. Personal and societal costs are important issues. Some suggested a pump service should be for low-income mothers, those with feeding difficulties or sick/preterm infants. A one-size service would not suit all and vouchers were proposed. Some suggested fees and deposits to prevent waste. To our knowledge, this is the first study reporting views about the acceptability of providing a free breast pump hire service. Mothers support and wish to have a say in breast pump service development. Future evaluations should address impact on feeding outcomes, professional support, hygiene for hired pumps, and costs.

Participant experiences of clean intermittent self-catheterisation, urinary tract infections and antibiotic use on the ANTIC trial - A qualitative study.

BACKGROUND: Recurrent urinary tract infections are a commonly reported problem in people who use clean intermittent self-catheterisation. Yet there is a lack of knowledge regarding both the impact on people's lives, the use of prophylactic anti-biotics and perceptions of patients on their use. AIMS: To explore the views and experiences of adults who use clean intermittent self-catheterisation for long-term bladder conditions, with a focus on urinary tract infection experience and prophylactic antibiotic use. DESIGN: A qualitative descriptive study. METHODS: Twenty-six semi-structured qualitative interviews were conducted with individuals recruited from the ANTIC Trial (Antibiotic treatment for intermittent bladder catheterisation: A randomised controlled trial of once daily prophylaxis). Participants were intermittent self-catheter users aged 18 years or older. Interviews took place between August 2015 and January 2016. Transcript data were analysed thematically. FINDINGS: Three overarching topics were revealed with corresponding themes: the experiences of intermittent self-catheterisation and urinary tract infections (normalisation, perceived burden); attitudes towards antibiotics for urinary tract infection treatment (nonchalant attitudes, ambivalence towards antibiotic resistance); and experiences of low-dose prophylaxis antibiotics (habitual behaviour and supportive accountability). CONCLUSION: The emotional and practical burden of catheter use and urinary tract infection was considerable. Beliefs pertaining to antibiotic use were based on utility, gravity of need and perceived efficacy. These opinions were often influenced by clinician recommendations.