Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.
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SUBMITTER: Sung VW
PROVIDER: S-EPMC5037009 | biostudies-literature | 2016 Oct
REPOSITORIES: biostudies-literature
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Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.
Sung Vivian W VW Borello-France Diane D Dunivan Gena G Gantz Marie M Lukacz Emily S ES Moalli Pamela P Newman Diane K DK Richter Holly E HE Ridgeway Beri B Smith Ariana L AL Weidner Alison C AC Meikle Susan S
International urogynecology journal 20160610 10
<h4>Introduction and hypothesis</h4>Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.<h4>Methods</h4>ESTEEM is a multisite, prospective, randomized trial of female pa ...[more]
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Project description:BackgroundMale stress urinary incontinence (SUI) is a known complication following surgical intervention on the prostate, particularly following surgery for prostate cancer. Effective surgical treatments for SUI include artificial urinary sphincter (AUS) and male urethral sling. Prior data suggest that men may forego available treatment despite bothersome symptoms. The objective was to explore how men who underwent surgical correction for post-prostatectomy SUI navigated SUI treatment decisions.MethodsMixed method study was employed. Semi-structured interviews, participant surveys and objective clinical assessment of SUI were performed among a group of men living with incontinence after prostate cancer surgery who underwent surgery for SUI at the University of California in 2017.ResultsEleven men were interviewed after consultation for SUI and all had complete quantitative clinical data. Surgery for SUI included AUS (n=8) and sling (n=3). There was a decrease in pads per day from 3.2 to 0.9 and no major complications. Most patients found that the impact on activities and their treating urologist were of great importance. Sexual and relationships played a variable role with some participants ranking these as "great deal of influence" and others "little or no influence". Participants who underwent AUS were more likely to cite a higher importance on "being very dry" in choosing that surgery while sling patients had more variable ranking of important factors. Participants found a variety of inputs helpful in hearing information about SUI treatment options.ConclusionsAmong a group of 11 men who underwent surgical correction for post-prostatectomy SUI, there were identifiable themes on how men make decisions, evaluate quality of life (QoL) changes and approach treatment options. Men value more than being dry with measures of individual success that can include sexual and relationship health. Furthermore the role of the Urologist remains crucial as patients relied heavily on input and discussion with their Urologist to assist in treatment decisions. These findings can be used to inform future studies of the experience of men with SUI.
| S-EPMC10251091 | biostudies-literature
Project description:ImportanceMixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.ObjectiveTo determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.Design, setting, and participantsRandomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.InterventionsBehavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).Main outcomes and measuresThe primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.ResultsAmong 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).Conclusions and relevanceAmong women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT01959347.
| S-EPMC6749544 | biostudies-literature
Project description:The aim of this debate article is to discuss whether effective treatments are available for mixed urinary incontinence (MUI). Because patients with MUI have both stress and urgency urinary incontinence (SUI and UUI) episodes and current treatment guidelines currently recommend treating the predominant symptom first, this article presents standard and emerging treatments for both SUI and UUI before discussing how well these treatments meet the medical needs of patients with MUI. Standard treatments presented include noninvasive options such as lifestyle changes and pelvic floor exercises, pharmacological agents, and surgery. Treatment of all three types of urinary incontinence (UI) is usually initiated with noninvasive options, after which treatment options diverge based on UI subtype. Multiple pharmacological agents have been developed for the treatment of UUI and overactive bladder, whereas surgery remains the standard option for SUI and stress-predominant MUI. The divide between UUI and SUI options seems to be propagated in emerging treatments, with most novel pharmacological agents still targeting UUI and even having SUI and stress-predominant MUI as exclusion criteria for participation in clinical trials. Considering that current treatment options focus almost exclusively on treating the predominant symptom of MUI and that emerging pharmacological treatments exclude patients with stress-predominant MUI during the development phase, effective treatments for MUI are lacking both in standard and emerging practice. Ideally, agents with dual mechanisms of action could provide symptom benefit for both the stress and urgency components of MUI.
| S-EPMC10092712 | biostudies-literature
Project description:BackgroundApp-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use.ObjectiveThe goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure.MethodsWe used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment.ResultsFour interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms).ConclusionsThis study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app.International registered report identifier (irrid)RR2-10.1002/nau.23507.
| S-EPMC8486988 | biostudies-literature
Project description:IntroductionPatient-centered care (PCC) is an approach to involve patients in health care delivery, to contribute to quality of care, and to strengthen health systems responsiveness. This article aims to highlight patient perspectives by showcasing their perceptions of their experience of PCC at primary health facilities in two districts in Uganda.MethodsA mixed methods cross-sectional study was conducted in three public and two private primary health care facilities in rural eastern Uganda. In total, 300 patient exit survey questionnaires, 31 semi-structured Interviews (SSIs), 5 Focus Group Discussions (FGDs) and 5 feedback meetings were conducted. Data analysis was guided by a conceptual framework focusing on (1) understanding patients' health needs, preferences and expectations, (2) describing patients perceptions of their care experience according to five distinct PCC dimensions, and (3) reporting patient reported outcomes and their recommendations on how to improve quality of care.ResultsPatient expectations were shaped by their access to the facility, costs incurred and perceived quality of care. Patients using public facilities reported doing so because of their proximity (78.3% in public PHCs versus 23.3% in private PHCs) and because of the free services availed. On the other hand, patients attending private facilities did so because of their perception of better quality of care (84.2% in private PHCs versus 21.7% in public PHCs). Patients expectations of quality care were expressed as the availability of medication, shorter waiting times, flexible facility opening hours and courteous health workers. Analysis of the 300 responses from patients interviewed on their perception of the care they received, pointed to higher normalized scores for two out of the five PCC dimensions considered: namely, exploration of the patient's health and illness experience, and the quality of the relationship between patient and health worker (range 62.1-78.4 out of 100). The qualitative analysis indicated that patients felt that communication with health workers was enhanced where there was trust and in case of positive past experiences. Patients however felt uncomfortable discussing psychological or family matters with health workers and found it difficult to make decisions when they did not fully understand the care provided. In terms of outcomes, our findings suggest that patient enablement was more sensitive than patient satisfaction in measuring the effect of interpersonal patient experience on patient reported outcomes.Discussion and conclusionOur findings show that Ugandan patients have some understanding of PCC related concepts and express a demand for it. The results offer a starting point for small scale PCC interventions. However, we need to be cognizant of the challenges PCC implementation faces in resource constrained settings. Patients' expectations in terms of quality health care are still largely driven by biomedical and technical aspects. In addition, patients are largely unaware of their right to participate in the evaluation of health care. To mitigate these challenges, targeted health education focusing on patients' responsibilities and patient's rights are essential. Last but not least, all stakeholders must be involved in developing and validating methods to measure PCC.
| S-EPMC7392339 | biostudies-literature
Project description:IntroductionEvidence specific for stress-predominant mixed urinary incontinence is still lacking at present, and acupuncture may relieve the symptoms. We plan to conduct this multi-centre, three-armed, randomised controlled trial to investigate the efficacy and safety of electroacupuncture among women with stress-predominant mixed urinary incontinence.Methods and analysisThe trial will be conducted at five hospitals in China. Two hundred thirty-two eligible women will be randomly assigned (2:1:1) to the electroacupuncture, sham electroacupuncture or waiting-list group to receive either 24-session acupuncture/sham acupuncture treatment over 8 weeks and 24-week follow-up or 20-week watchful waiting. The primary outcome is the proportion of participants with at least 50% reduction in mean 24-hour stress incontinence episode frequencies from baseline to week 8. The outcome will be analysed with the intention to treatpopulation (defined as participants randomised) with a two-sided p value of less than 0.05 considered significant.Ethics and disseminationThe protocol has been approved by Guang'anmen Hospital Institutional Review Board (2019-241-KY). Detailed information of the trial will be informed to the participants, and written informed consent will be obtained from every participant. Results of the trial are expected to be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT04299932).
| S-EPMC7797267 | biostudies-literature
Project description:Introduction & hypothesisPrevious studies have suggested that women with urinary incontinence have an altered urinary microbiome. We hypothesized that the microbiome in women with mixed urinary incontinence (MUI) differed from controls and tested this hypothesis using bacterial gene sequencing techniques.MethodsThis multicenter study compared the urinary microbiome in women with MUI and similarly aged controls. Catheterized urine samples were obtained; v4-6 regions of the 16S rRNA gene were sequenced to identify bacteria. Bacterial predominance (> 50% of an individual's genera) was compared between MUI and controls. Bacterial sequences were categorized into "community types" using Dirichlet multinomial mixture (DMM) methods. Generalized linear mixed models predicted MUI/control status based on clinical characteristics and community type. Post-hoc analyses were performed in women < 51 and ≥ 51 years. Sample size estimates required 200 samples to detect a 20% difference in Lactobacillus predominance with P < 0.05.ResultsOf 212 samples, 97.6% were analyzed (123 MUI/84 controls, mean age 53 ± 11 years). Overall Lactobacillus predominance did not differ between MUI and controls (45/123 = 36.6% vs. 36/84 = 42.9%, P = 0.36). DMM analyses revealed six community types; communities differed by age (P = 0.001). A High-Lactobacillus (89.2% Lactobacillus) community had a greater proportion of controls (19/84 = 22.6%, MUI 11/123 = 8.9%). Overall, bacterial community types did not differ in MUI and controls. However, post-hoc analysis of women < 51 years found that bacterial community types distinguished MUI from controls (P = 0.041); Moderate-Lactobacillus (aOR 7.78, CI 1.85-32.62) and Mixed (aOR 7.10, CI 1.32-38.10) community types were associated with MUI. Community types did not differentiate MUI and controls in women ≥ 51 years (P = 0.94).ConclusionsWomen with MUI and controls did not differ in overall Lactobacillus predominance. In younger women, urinary bacterial community types differentiated MUI from controls.
| S-EPMC6295358 | biostudies-literature
Project description:BackgroundUrinary incontinence (UI) is prevalent in women and has been associated with decreased quality of life and institutionalization. Despite this, and the fact that several treatment options exist, few women discuss UI with clinicians. The aim of this study was to examine the proportion of middle aged and older women with urinary incontinence who have discussed UI with clinicians, focusing on female health professionals as a way to examine this question outside of issues of health care access.MethodsData are from the Nurses Health Studies (NHS), two ongoing observational, prospective, cohort studies. The surveys collected detailed information about UI, including frequency, amount and type. Women were also asked if they had discussed UI with a clinician. We used multivariable-adjusted logistic regression to estimate odds ratios (OR) of participants reporting discussion about UI.Results94,692 women with UI aged 49-91 years old were included in this study. Of these, 34% reported that they had discussed their incontinence with a clinician. Women with daily UI had 4.4 times greater odds of discussing it with clinicians when compared to those with monthly UI (OR = 4.36, 95% confidence interval [CI] 4.06-4.69). When controlling for severity of symptoms, the oldest women, greater than eighty years, were 20% less likely to have discussed UI with their clinician, compared to the youngest women (OR = 0.81, 95% CI 0.73-0.89).ConclusionsA minority of women with UI, even among health professionals, discuss their symptoms with clinicians. Oldest women were the least likely to discuss their UI with a provider.
| S-EPMC7907491 | biostudies-literature
Project description:BackgroundMany women experience urgency (UUI) and mixed (MUI) urinary incontinence but commonly hesitate to seek care. Treatment access and self-management for these conditions can be supported through eHealth approaches.ObjectiveThis study aimed to investigate the efficacy of the mobile app Tät II for self-management of UUI and MUI in women.MethodsThis randomized controlled trial included women ≥18 years old with UUI or MUI and ≥2 leakages per week. Those with red-flag symptoms were excluded. Participants were recruited via analog and digital advertisements and screened for initial selection through a web-based questionnaire. Data were collected using another questionnaire and a 2-day bladder diary. A telephone interview confirmed the symptom diagnosis. Participants were randomized (1:1) to receive access to a treatment app (including pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, tailored advice, exercise log, reinforcement messages, and reminders) or an information app (control group), with no external treatment guidance provided. The primary outcome was incontinence symptoms at the 15-week follow-up, measured using the International Consultation on Incontinence Questionnaire (ICIQ)-Urinary Incontinence Short Form (ICIQ-UI SF). Urgency symptoms were assessed using the ICIQ-Overactive Bladder Module (ICIQ-OAB) and quality of life using the ICIQ-Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). Incontinence episode frequency (IEF) was calculated per bladder diary entries. Improvement was measured using the Patient's Global Impression of Improvement. All outcomes were self-reported. Cure was defined as no leakages per the bladder diary. Intention-to-treat analysis was performed.ResultsBetween April 2017 and March 2018, 123 women (mean age 58.3, SD 9.6 years) were randomized to the treatment (n=60, 2 lost to follow-up) or information (n=63) group. Of these, 35 (28%) women had UUI, and 88 (72%) had MUI. Mean ICIQ-UI SF score at follow-up was lower in the treatment group than in the information group (estimated difference -3.1, 95% CI -4.8 to -1.3). The estimated between-group difference was -1.8 (95% CI -2.8 to -0.99) for mean ICIQ-OAB score and -6.3 (95% CI -10.5 to -2.1) for the mean ICIQ-LUTSqol score at follow-up. IEF reduction from baseline to follow-up was greater in the treatment group (-10.5, IQR -17.5 to -3.5) than in the information group (P<.001). Improvement was reported by 87% (52/60) of treatment group participants and by 30% (19/63) of information group participants. The cure rate was 32% in the treatment group, and 6% in the information group (odds ratio 5.4, 95% CI 1.9-15.6; P=.002). About 67% (40/60) of the treatment group participants used the app more than thrice a week.ConclusionsThe treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative to pharmacological treatment or other conservative management, thus increasing access to care.Trial registrationClinicalTrials.gov NCT03097549; https://clinicaltrials.gov/ct2/show/NCT03097549.
| S-EPMC8056293 | biostudies-literature
Project description:Patient education is key to preventing hospital falls yet is inconsistently implemented by health professionals. A mixed methods study was conducted involving a ward-based evaluation of patients receiving education from health professionals using a scripted conversation guide with a falls prevention brochure, followed by semi-structured qualitative interviews with a purposive sample of health professionals involved in delivering the intervention. Over five weeks, 37 patients consented to surveys (intervention n = 27; control n = 10). The quantitative evaluation showed that falls prevention education was not systematically implemented in the trial ward. Seven individual interviews were conducted with health professionals to understand the reasons why implementation failed. Perceived barriers included time constraints, limited interprofessional collaboration, and a lack of staff input into designing the research project and patient interventions. Perceived enablers included support from senior staff, consistent reinforcement of falls education by health professionals, and fostering patient empowerment and engagement. Recommended strategies to enhance implementation included ensuring processes were in place supporting health professional accountability, the inclusion of stakeholder input in designing the falls intervention and implementation processes, as well as leadership engagement in falls prevention education. Although health professionals play a key role in delivering evidence-based falls prevention education in hospitals, implementation can be compromised by staff capacity, capability, and opportunities for co-design with patients and researchers. Organisational buy-in to practice change facilitates the implementation of evidence-based falls prevention activities.
| S-EPMC9316918 | biostudies-literature