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Lookup NU author(s): Nicole O'ConnorORCiD, Sheila WallaceORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
Hypothesis / aims of studyUrinary incontinence (UI) is highly prevalent among women 60 years and over, impairing their quality of life and leading to various health complications (1). The condition is often overlooked and untreated due to misconceptions about aging (2). Globally, UI poses a significant social, economic, and health burden, especially considering the increasing older adult population (3). The aim of this study was to determine the efficacy and safety of conservative, pharmacological, and surgical treatments for the safety, cure and cure and improvement of UI in women 60 years and over using network meta-analysis (NMA), and to rank the numerous interventions within one treatment network. This approach addresses how menopause and ageing, along with associated comorbidities, affect treatment efficacy and safety, ultimately guiding optimal care for older women with UI.Study design, materials and methodsWe searched the Cochrane Incontinence Specialized Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP, and hand searching of journals and conference proceedings (searched 13 July 2023), and reference lists of relevant articles. We included all randomized controlled trials (RCTs) which evaluated the effectiveness of different treatments (conservative, pharmacological and surgery) for the treatment of stress, urgency, mixed or unclassified types of UI according to symptoms, signs and/or urodynamic evaluation, as defined by the trial investigators in older women (i.e., women 60 years and over). We included studies involving participants with symptoms of overactive bladder, pelvic organ prolapse and had undergone previous treatments for UI only if UI was present. At least two reviewers independently screened titles and abstracts, followed by the full-text for all relevant articles. At least two review authors independently performed data extraction, risk of bias assessment (RoB) using the RoB 2 tool and evidence certainty assessment using the ‘Confidence in Network Meta-Analysis’ CINeMA approach.ResultsAfter exclusions, 43 RCTs involving 8,506 participants with a mean of 198 participants per study (range 14 to 1438) remained. There were 20 different active treatment nodes, administered either alone or in combination. The treatment nodes predominantly comprised pharmacological treatment, followed by surgical treatments, with a relatively small number of conservative treatment nodes. Most trials (28/43, 65%) compared treatment against placebo/no treatment. The majority of the studies included conservative treatments (20/43, 46.5%), followed by pharmacological (17/43, 39.5%), surgical treatments (4/43, 9.3%) and mixed types of treatments (2/43, 4.7%). The trials presented variable RoB, often presenting 'some concerns' or 'high risk,' with poor reporting on randomization, blinding, and protocol details. Conservative or pharmacological treatments showed high RoB for most outcomes.CureCure of UI was measured in 18 studies. Many of the studies included in the analysis used participants' subjective measures, such as self-reported absence of leakage recorded in urinary diaries, participants' perception of cure as assessed through interviews or questionnaires, or cure derived from adapted questionnaires. Other methods used to assess cure included reports of wet episodes checked by the research staff and objective measures such as cough tests and pad tests. For cure, the network was adjusted by excluding certain studies to address disconnections, leading to a comparison primarily among physical therapies (with or without additional treatments), antimuscarinic drugs, and controls.Results (Table 1 and Figure 1) indicated that all treatments might be better than control, with physical therapies - mainly pelvic floor muscle training with or without complementary therapies, showing the best performance for curing UI (physical therapies + complementary therapies: OR 22.94, 95% CI 1.26 to 418.19, low certainty evidence; physical therapies: OR 8.94, 95% CI 1.97 to 40.51, very low certainty evidence; complementary therapies: OR 6.00, 95% CI 0.32 to 113.4, very low certainty evidence). Across the three treatments that included physical therapies the likelihood of being ranked first or in one of the top ranks was higher than for the other treatments (SUCRA values ranging from 56.5% to 84.9%) but the certainty of the evidence was low to very low.Cure or improvementCure or improvement of UI symptoms was measured in 17 studies. The reported measures included subjective assessments using questionnaires and/or questionnaire-related inquiries regarding participant perceptions of cure and improvement as well as the reduction in the number of daily recorded urinary episodes. One study reported improvement based on the reports of wet episodes checked by the research staff. Results in Table 1 and Figure 1 show that physical therapies, with or without education, performed best compared to controls (physical therapies: OR 3.98, 95% CI 2.02 to 7.82, very low certainty evidence; physical therapies + education: OR 3.20, 95% CI 1.45 to 7.02, very low certainty evidence; β3-adrenergic agonists: OR 2.44, 95% CI 1.28 to 4.62, very low certainty evidence). Physical therapies with or without addition of an educational treatment were the best performing treatments (when compared to control) (physical therapies: SUCRA = 89.9%; physical therapies + education: SUCRA = 77.3%).SafetyOf the included studies, 16 provided information on serious adverse events (SAEs) (i.e., occurrence or absence). There was considerable heterogeneity in data with variation across reports, including differences in the selection, specification, and classification of SAEs, as well as in the method of measurement (e.g., reporting the number of events versus the number of participants experiencing SAEs).Results in Table 1 and Figure 1 showed relatively few reported SAEs across trials and there was no treatment that was superior in terms of having significantly less chance of SAEs (serotonin-noradrenaline uptake inhibitors: OR 0.4, 95% CI 0.1 to 1.59; β3-adrenergic agonists: OR 0.61, 95% CI 0.04 to 10.19; complementary therapies: OR 0.53, 95% CI 0.00 to 71.05).Surgical therapies were not assessed in the NMA due to gaps in the data.Interpretation of resultsThis review compared treatments for women 60 years and over, using a NMA to rank treatments based on cure, cure or improvement of UI symptoms, and SAEs. Including 43 studies with 8,506 participants, it focused on conservative, pharmacological, and surgical treatments. Physical therapies, especially when combined with complementary therapies or education, were the most likely to be in the highest rank or ranks for cure, and cure or improvement of UI symptoms however with low to very-low certainty of evidence. There was a lack of uniformity and consistency in how SAEs were reported making our results difficult to interpret. Only studies focusing on pharmacological treatments reported SAEs, with the number of events ranging from none to low. In contrast, studies focusing on conservative treatments reported no SAEs.Concluding messageThis review suggests that physical therapies, with or without educational or complementary therapies, show promise for treating UI in older women, though the certainty of the evidence is low to very low. The limited number of small studies contributes to uncertainty about treatment efficacy. There is a need for more studies on conservative, pharmacological and surgical treatments with standardized outcomes and clear reporting of interventions and adverse events to improve UI management in aging women.Funding This work was supported by the Centre de recherche de l’Institut universitaire de gériatrie de Montréal and Fonds de recherche du Québec – Santé (FRQS). CD received a salary award from the Canadian Research Chair Tier II program (2021-2022) Clinical Trial No Subjects Human Ethics not Req'd Systematic review and network meta-analysis Helsinki not Req'd Systematic review and network meta-analysis Informed Consent No
Author(s): Vesentini G, O'Connor N, Le Berre N, Nabhan AF, Wagg A, Wallace S, Dumoulin C
Publication type: Conference Proceedings (inc. Abstract)
Publication status: Published
Conference Name: International Continence Society (ICS 2024)
Year of Conference: 2024
Pages: 101582
Print publication date: 01/10/2024
Online publication date: 11/10/2024
Acceptance date: 30/09/2024
Date deposited: 30/11/2024
ISSN: 2772-9737
Publisher: Elsevier
URL: https://doi.org/10.1016/j.cont.2024.101582
DOI: 10.1016/j.cont.2024.101582
Series Title: Continence
