Melbourne School of Health Sciences Collected Works - Research Publications

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    Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial
    Bick, D ; Bishop, J ; Coleman, T ; Dean, S ; Edwards, E ; Frawley, H ; Gkini, E ; Hay-Smith, J ; Hemming, K ; Jones, E ; Oborn, E ; Pearson, M ; Salmon, V ; Webb, S ; MacArthur, C (BMC, 2022-10-22)
    BACKGROUND: Antenatal pelvic floor muscle exercises (PFME) in women without prior urinary incontinence (UI) are effective in reducing postnatal UI; however, UK midwives often do not provide advice and information to women on undertaking PFME, with evidence that among women who do receive advice, many do not perform PFME. METHODS: The primary aim of this feasibility and pilot cluster randomised controlled trial is to provide a potential assessment of the feasibility of undertaking a future definitive trial of a midwifery-led antenatal intervention to support women to perform PFME in pregnancy and reduce UI postnatally. Community midwifery teams in participating NHS sites comprise trial clusters (n = 17). Midwives in teams randomised to the intervention will be trained on how to teach PFME to women and how to support them in undertaking PFME in pregnancy. Women whose community midwifery teams are allocated to control will receive standard antenatal care only. All pregnant women who give birth over a pre-selected sample month who receive antenatal care from participating community midwifery teams (clusters) will be sent a questionnaire at 10-12 weeks postpartum (around 1400-1500 women). Process evaluation data will include interviews with midwives to assess if the intervention could be implemented as planned. Interviews with women in both trial arms will explore their experiences of support from midwives to perform PFME during pregnancy. Data will be stored securely at the Universities of Birmingham and Exeter. Results will be disseminated through publications aimed at maternity service users, clinicians, and academics and inform a potential definitive trial of effectiveness. The West Midlands-Edgbaston Research Ethics Committee approved the study protocol. DISCUSSION: Trial outcomes will determine if criteria to progress to a definitive cluster trial are met. These include women's questionnaire return rates, prevalence of UI, and other health outcomes as reported by women at 10-12 weeks postpartum. Progress to a definitive trial however is likely to be prevented in the UK context by new perinatal pelvic health service, although this may be possible elsewhere. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN10833250 . Registered 09/03/2020.
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    The feasibility of pelvic floor training to treat urinary incontinence in women with breast cancer: a telehealth intervention trial
    Colombage, UN ; Soh, S-E ; Lin, K-Y ; Kruger, J ; Frawley, HC (SPRINGER JAPAN KK, 2023-01)
    PURPOSE: To investigate the feasibility of recruiting into a pelvic floor muscle training (PFMT) program delivered via telehealth to treat urinary incontinence (UI) in women with breast cancer on aromatase inhibitors. METHODS: We conducted a pre-post single cohort clinical trial with 54 women with breast cancer. Participants underwent a 12-week PFMT program using an intra-vaginal pressure biofeedback device: femfit®. The intervention included eight supervised individual PFMT sessions over Zoom™ and a 12-week home exercise program. The primary outcome of this study was feasibility, specifically consent rate. Secondary outcomes which included prevalence and burden of UI measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), and pelvic floor muscle (PFM) strength measured as intravaginal squeeze pressure were compared using McNemar's and paired t tests. RESULTS: The mean age of participants was 50 years (SD ± 7.3). All women who were eligible to participate in this study consented (n = 55/55, 100%). All participants reported that the program was beneficial and tailored to their needs. The results showed a statistically significant decline in the prevalence (percentage difference 42%, 95% CI 28, 57%) and burden (ICIQ-UI SF score mean change 9.4, 95% CI 8.5, 10.4) of UI post intervention. A significant increase in PFM strength was observed post-intervention (mean change 4.8 mmHg, 95% CI 3.9, 5.5). CONCLUSION: This study indicated that PFMT delivered via telehealth may be feasible and potentially beneficial in treating stress UI in women with breast cancer. Further studies such as randomized controlled trials are required to confirm these results.
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    Effect of Early and Intensive Telephone or Electronic Nutrition Counselling Delivered to People with Upper Gastrointestinal Cancer on Quality of Life: A Three-Arm Randomised Controlled Trial
    Huggins, CE ; Hanna, L ; Furness, K ; Silvers, MA ; Savva, J ; Frawley, H ; Croagh, D ; Cashin, P ; Low, L ; Bauer, J ; Truby, H ; Haines, TP (MDPI, 2022-08)
    BACKGROUND: Delay in dietetic service provision for upper gastrointestinal cancer exacerbates disease-related malnutrition and consequently increases morbidity and mortality. Dietetic services are usually referral-based and provided face-to-face in inpatient or outpatient settings, which can delay the commencement of nutrition care. The aim of this study was to provide intensive dietetic intervention close to the time of diagnosis for upper gastrointestinal cancer and assess the effect on quality-adjusted life years. METHODS: A three-arm randomised controlled trial of adults newly diagnosed with upper gastrointestinal cancer was performed. A behavioural-based, individually tailored, symptom-directed nutrition intervention was provided in addition to usual care, delivered by a dietitian using a telephone (synchronously) or a mobile application (asynchronously) for 18 weeks, compared with a usual care control group. Data were collected at baseline, three, six, and twelve months post-randomisation. The primary outcome was quality-adjusted life years (EQ-5D-5L quality of life assessment tool). Data were analysed using linear mixed models. RESULTS: One hundred and eleven participants were randomised. Quality-adjusted life years were not different in the intervention groups compared with control (telephone: mean (95% CI) 0.04 (0.43, 2.3), p = 0.998; App: -0.08 (-0.18, 0.02), p = 0.135) after adjustment for baseline, nutrition risk status, age, and gender. Survival was similar between groups over 12 months. The asynchronous mobile app group had a greater number of withdrawals compared with the telephone group. CONCLUSION: Early and intensive nutrition counselling, delivered at home, during anticancer treatment did not change quality-adjusted life years or survival over 12 months compared with usual care. Behavioural counselling alone was unable to achieve nutritional adequacy. Dietetic services delivered asynchronously using a mobile app had low acceptance for patients undergoing anticancer treatment. TRIAL REGISTRATION: 27 January 2017 Australian and New Zealand Clinical Trial Registry, ACTRN12617000152325.
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    Experiences of pelvic floor dysfunction and treatment in women with breast cancer: a qualitative study
    Colombage, UN ; Lin, K-Y ; Soh, S-E ; Brennen, R ; Frawley, HC (SPRINGER, 2022-10)
    PURPOSE: To explore the experiences of women with breast cancer and pelvic floor (PF) dysfunction and the perceived enablers and barriers to uptake of treatment for PF dysfunction during their recovery. METHOD: Purposive sampling was used to recruit 30 women with a past diagnosis of breast cancer and PF dysfunction. Semi-structured interviews were conducted, and data were analysed inductively to identify new concepts in the experiences of PF dysfunction in women with breast cancer and deductively according to the capability, opportunity, motivation and behaviour (COM-B) framework to identify the enablers and barriers to the uptake of treatment for PF dysfunction in women with breast cancer. RESULTS: Participants were aged between 31 and 88 years, diagnosed with stages I-IV breast cancer and experienced either urinary incontinence (n = 24/30, 80%), faecal incontinence (n = 6/30, 20%) or sexual dysfunction (n = 20/30, 67%). They were either resigned to or bothered by their PF dysfunction; bother was exacerbated by embarrassment from experiencing PF symptoms in public. Barriers to accessing treatment for PF dysfunction included a lack of awareness about PF dysfunction following breast cancer treatments and health care professionals not focussing on the management of PF symptoms during cancer treatment. An enabler was their motivation to resume their normal pre-cancer lives. CONCLUSION: Participants in this study reported that there needs to be more awareness about PF dysfunction in women undergoing treatment for breast cancer. They would like to receive information about PF dysfunction prior to starting cancer treatment, be screened for PF dysfunction during cancer treatment and be offered therapies for their PF dysfunction after primary cancer treatment. Therefore, a greater focus on managing PF symptoms by clinicians may be warranted in women with breast cancer.
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    Patient and clinician perspectives of pelvic floor dysfunction after gynaecological cancer
    Brennen, R ; Lin, K-Y ; Denehy, L ; Soh, S-E ; Frawley, H (ELSEVIER SCIENCE INC, 2022-06)
    PURPOSE: To explore and compare patient and clinician experiences, knowledge and preferences in relation to screening and management of pelvic floor (PF) dysfunction in the gynaecology-oncology setting. METHODS: Semi-structured interviews were conducted with women reporting PF symptoms after gynaecological cancer treatment, and gynaecology-oncology clinicians. Interviews were transcribed and thematically analysed and were conducted until data saturation was reached. RESULTS: We interviewed 12 patients and 13 clinicians. We identified two main themes: (1) Experience with PF symptoms, screening, disclosure and management and (2) Future hope of what should happen to screen and manage PF symptoms. Differences between what participants had experienced and what they felt should happen highlighted a perceived need for improving PF screening and management. A sub-theme that reflected relevant barriers and enablers was also identified. Barriers included time pressure, being focussed on cancer treatment and not side-effects, and patients feeling unwell, emotional, and overwhelmed with the logistics of oncology appointments. Enablers included the patient-clinician relationship, and opportunities for improving management included integrating nursing and PF physiotherapy with oncology appointments. CONCLUSIONS: Gynaecological cancer survivors and clinicians perceive a need to improve screening and management for PF symptoms. While barriers and differences in perception exist, there are opportunities to improve how PF symptoms can be screened and managed in this population. Further studies exploring the feasibility of providing integrated multidisciplinary PF therapy services may be warranted.
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    The 2018 annual cost burden for children under five years of age hospitalised with respiratory syncytial virus in Australia
    Brusco, NK ; Alafaci, A ; Tuckerman, J ; Frawley, H ; Pratt, J ; Daley, AJ ; Todd, AK ; Deng, Y-M ; Subbarao, K ; Barr, I ; Crawford, NW (AUSTRALIAN GOVERNMENT, DEPT HEALTH & AGEING, 2022-02-16)
    Respiratory syncytial virus (RSV) is one of the principal causes of acute bronchiolitis and respiratory tract infections in young children. Routine RSV surveillance in Australian children is limited; vaccines are in late stage development; prophylactic monoclonal antibody (mAb) treatment is available but expensive; and there has been uncertainty around the cost burden. The objective of this study was to determine the annual cost burden for children under five years of age hospitalised with RSV in a single health service in 2018, with national extrapolation based on published Australian prevalence data. The methods utilised individual patient-level cost data prospectively collected for hospitalised children under five years of age in a tertiary Melbourne paediatric hospital. Results were extrapolated to all Australian children under five years of age to determine the national annual health cost burden, from a healthcare sector perspective over a 12 month time horizon. The results included 363 children with a mean age of 9.2 months (standard deviation, SD: 8.5 months). The mean cost per child was $17,120 (SD: $37,562), with a combined health service cost of $6,214,439. The reported Australian hospitalisation rate for RSV in the target age group ranged from 2.2 to 4.5 per 1,000 children under five years of age, resulting in a 2018 extrapolated cost range of $59,218,844-$121,129,453 for the estimated 3,459-7,075 children affected (combined index and all-cause six-month readmissions). This study concluded that RSV represents a significant cost burden to Australia's health care system. These data are important for future health economic assessments of preventative therapies, such as new RSV mAb treatments and maternal/childhood RSV vaccines, and provides valuable insights to inform health care planning and health policy.
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    The Australian Pelvic Floor Questionnaire is a valid measure of pelvic floor symptoms in patients following surgery for colorectal cancer
    Lin, K-Y ; Frawley, HC ; Granger, CL ; Denehy, L (WILEY, 2017-06)
    AIMS: This study evaluated the construct validity of the Australian Pelvic Floor Questionnaire against two alternative measures of the severity of bladder and bowel symptoms. METHODS: This was an exploratory analysis of data from two prospective studies. Patients who had undergone surgery for colorectal cancer were analysed. Bladder and bowel symptoms were measured using three validated questionnaires: the Australian Pelvic Floor Questionnaire, the International Consultation on Incontinence Questionnaire Short Form Questionnaire for urinary incontinence and the International Consultation on Incontinence Questionnaire-Bowel Module post-cancer treatment. RESULTS: The study sample consisted of 44 participants, including 25 men and 19 women. The Australian Pelvic Floor Questionnaire bladder and bowel domain scores demonstrated moderate positive correlations with the International Consultation on Incontinence Questionnaire Short Form Questionnaire for urinary incontinence (r = 0.74, P < 0.01) and the International Consultation on Incontinence Questionnaire-Bowel Module (r = 0.69-0.78, P < 0.01). Similar results were obtained in each gender subgroup. CONCLUSIONS: This study suggested that the Australian Pelvic Floor Questionnaire may be a valid measurement tool for use in colorectal cancer populations in clinical trials and practice. Future research using larger cohorts is warranted.
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    Peripheral, Central, and Cross Sensitization in Endometriosis-Associated Pain and Comorbid Pain Syndromes.
    McNamara, HC ; Frawley, HC ; Donoghue, JF ; Readman, E ; Healey, M ; Ellett, L ; Reddington, C ; Hicks, LJ ; Harlow, K ; Rogers, PAW ; Cheng, C (Frontiers Media S.A., 2021)
    Endometriosis-associated pain and the mechanisms responsible for its initiation and persistence are complex and difficult to treat. Endometriosis-associated pain is experienced as dysmenorrhea, cyclical pain related to organ function including dysuria, dyschezia and dyspareunia, and persistent pelvic pain. Pain symptomatology correlates poorly with the extent of macroscopic disease. In addition to the local effects of disease, endometriosis-associated pain develops as a product of peripheral sensitization, central sensitization and cross sensitization. Endometriosis-associated pain is further contributed to by comorbid pain conditions, such as bladder pain syndrome, irritable bowel syndrome, abdomino-pelvic myalgia and vulvodynia. This article will review endometriosis-associated pain, its mechanisms, and its comorbid pain syndromes with a view to aiding the clinician in navigating the literature and terminology of pain and pain syndromes. Limitations of our current understanding of endometriosis-associated pain will be acknowledged. Where possible, commonalities in pain mechanisms between endometriosis-associated pain and comorbid pain syndromes will be highlighted.
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    The impact of pelvic organ prolapse and/or continence surgery on pelvic floor muscle function in women: A systematic review
    Mastwyk, S ; McClelland, J ; Rosamilia, A ; Frawley, H (WILEY, 2019-08)
    AIMS: To systematically review the evidence for the effect of pelvic organ prolapse (POP) and/or continence surgery on pelvic floor muscle (PFM) morphometry and function in women, and to investigate whether a relationship exists between PFM measures and clinician-reported objective pelvic floor outcomes postoperatively. METHODS: Six electronic databases were searched until March 2018. Studies were included if they examined the effect of POP and/or continence surgery on the PFM in women, and reported pre- and postoperative data. Methodological quality was assessed using a modified Downs and Black checklist. Three meta-analyses were planned based on postoperative follow-up time. RESULTS: Twenty-one studies met the inclusion criteria. Varied surgical interventions and 33 different PFM measures were represented. The methodological quality of included studies varied considerably. The 0 to 6 weeks postoperative meta-analysis showed no statistically significant change in PFM function (SMD = 0.04; 95% confidence interval [CI] = -0.26 to 0.33). This was consistent at 3 and 6 or more months (SMD = 1.13; 0.35 95% CI = -0.34 to 2.60, - 0.42 to 1.12 respectively). None of the included studies investigated the relationship between PFM measures and clinician-reported objective outcomes postoperatively. CONCLUSIONS: This review did not show a clear effect of POP and/or continence surgery on PFM morphometry or function in women and was unable to show a relationship with outcomes such as objective prolapse score and urodynamic findings. This could be because surgery does not measurably impact on the PFM or due to the poor quality and heterogeneity of studies. Future well-designed research is needed to specifically investigate change in the PFM following surgery.
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    Does pelvic floor muscle maximum voluntary contraction improve after vaginal pelvic organ prolapse surgery? A prospective study
    Duarte, TB ; Bonacin, MAP ; Brito, LGO ; Frawley, H ; Dwyer, PL ; Thomas, E ; Ferreira, CHJ (WILEY, 2018-06)
    AIMS: to assess pelvic floor muscle maximum voluntary contraction (MVC) before and after surgical treatment for pelvic organ prolapse (POP). METHODS: This was a prospective observational study with women scheduled for surgical correction of POP. Assessments occurred 15 days before and 40 days after surgery. The primary outcome was pelvic floor muscle (PFM) MVC measured using the manometer Peritron™. The average strength of PFM contraction was also measured. Secondary outcomes were assessed using the Pelvic Organ Prolapse Quantification (POP-Q) score. The Student paired t-test was used for quantitative data. For the pre and postsurgery comparisons of PFM strength in relation to POP-Q value we used the nonparametric Kruskal-Wallis test for dependent variables. The level of significance adopted was P < 0.05. RESULTS: Sixty-seven women were recruited, 65 (97%) completed the study. The mean age of participants was 62 ± 10.2. There was no difference (1.9 cm H2 O ± 12.9; P = 0.22) between MVC before (27.1 cm H2 O ± 17.0) and after surgery (29 cm H2 O ± 17.8). The average contraction was higher after surgery (2.3 cmH2 O ± 8.6; P = 0.03). The higher the severity of pre and postsurgery POP, the worse the MVC. CONCLUSION: There was no difference in MVC pre and postsurgery, however we found an improvement in PFM average contraction strength postsurgery.