Dataset Information

Digital Care Program for Urinary Incontinence in Females: A Large-Scale, Prospective, Cohort Study.

ABSTRACT: Female urinary incontinence (UI) is highly prevalent in the US (>60%). Pelvic floor muscle training (PFMT) represents first-line care for UI; however, access and adherence challenges urge new care delivery models. This prospective cohort study investigates the feasibility and safety of a remote digital care program (DCP) combining education and PFMT with real-time biofeedback with an average duration of 10 weeks. The primary outcome was the change in the Urinary Impact Questionnaire-short form (UIQ-7) from baseline to program-end, calculated through latent growth curve analysis (LGCA). Secondary outcomes included the impact of pelvic conditions (PFIQ-7), depression (PHQ-9), anxiety (GAD-7), productivity impairment (WPAI), intention to seek additional healthcare, engagement, and satisfaction. Of the 326 participants who started the program, 264 (81.0%) completed the intervention. Significant improvement on UIQ-7 (8.8, 95%CI 4.7; 12.9, p < 0.001) was observed, corresponding to a response rate of 57.3%, together with improvements in all other outcomes and high satisfaction (8.9/10, SD 1.8). This study shows the feasibility and safety of a completely remote DCP with biofeedback managed asynchronously by a physical therapist to reduce UI-related symptoms in a real-world setting. Together, these findings may advocate for the exploration of this care delivery option to escalate access to proper and timely UI care.

SUBMITTER: Janela D

PROVIDER: S-EPMC10815799 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Digital Care Program for Urinary Incontinence in Females: A Large-Scale, Prospective, Cohort Study.

Janela Dora D Areias Anabela C AC Molinos Maria M Moulder Robert G RG Magalhães Ivo I Bento Virgílio V Cardeano Marta M Yanamadala Vijay V Correia Fernando Dias FD Atherton Jennesa J Costa Fabíola F

Healthcare (Basel, Switzerland) 20240108 2

Female urinary incontinence (UI) is highly prevalent in the US (>60%). Pelvic floor muscle training (PFMT) represents first-line care for UI; however, access and adherence challenges urge new care delivery models. This prospective cohort study investigates the feasibility and safety of a remote digital care program (DCP) combining education and PFMT with real-time biofeedback with an average duration of 10 weeks. The primary outcome was the change in the Urinary Impact Questionnaire-short form ( ...[more]

PMID: 38255031

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Project description:BackgroundUrinary incontinence is frequent in the general population and affects men and women of all ages. UI carries an unsuspected load on the healthcare system. To investigate whether urinary incontinence is associated with all-cause, cardiovascular disease (CVD) and cancer mortality among US adults.MethodsThe analyzed data was collected from the 2007-2016 National Health and Nutrition Examination Survey (NHANES) data. A total of 25,182 US participants with complete information about follow-up information and urinary incontinence (UI) were included in this cohort study. Univariate Cox regression analyses, the UpSet plot, multivariate Cox regression analysis, subgroup analysis of all-cause mortality, and Kaplan-Meier survival curve were employed to support the research objectives.ResultsA total of 25,182 participants had a mean age of 49.8 ± 17.8 years, with 49.3% of them being male and 50.7% of them being female. In the unadjusted model, we found that the risk of all-cause mortality increased by 12% (95% CI 1.03-1.22, P = 0.008), the risk of CVD mortality increased by 21% (95% CI 1.07-1.36, P = 0.002), and the risk of Cancer mortality increased by 8% (95% CI 0.95-1.22, P = 0.243) among individuals with urinary incontinence. After adjusting for multiple variables, we found that the risk of all-cause mortality in patients with urinary incontinence decreased by 1% (95% CI 0.9-1.09), but this decrease was statistically insignificant (P = 0.868), and the risk of Cancer mortality decreased by 3% (95% CI 0.84-1.12, P = 0.686). The association between urinary incontinence and mortality risk were stable in stratified analyses.ConclusionsIn our study, we found that urinary incontinence itself is an independent risk factor for death. The association between urinary incontinence and mortality became less significant after adjusting for covariates, this is a common occurrence in statistical analysis. Future research, with larger sample sizes and more robust study designs, is needed to further elucidate the complex relationship between urinary incontinence and mortality risk.

Project description:ObjectiveTo evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI).MethodsIn a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting.ResultsFrom September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3-8) and 5 (3-8) episodes to 1 (0-3) and 2 (1-4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21-3.15). There were no device-related severe adverse events.ConclusionIn this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program.Clinical trial registrationClinicalTrials.gov, NCT04508153.Funding sourceRenovia Inc.

Project description:BackgroundFixed and adjustable male slings for the treatment of male urinary stress incontinence became increasingly popular during the last decade. Although fixed slings are recommended for the treatment of mild to moderate stress urinary incontinence, there is still a lack of evidence regarding the precise indication for an adjustable male sling. Furthermore, there is still no evidence that one type of male sling is superior to another. However, both, adjustable and fixed slings, are commonly utilized in daily clinical practice. This current investigation aims to evaluate the differences between fixed and adjustable male slings regarding indications, complication rates and functional outcome in the treatment of male stress urinary incontinence in current clinical practice.MethodsA total of 294 patients with a fixed and 176 patients with an adjustable male sling were evaluated in a multicenter single arm cohort trial. Data collection was performed retrospectively according the medical record. Functional outcome was prospectively analyzed by standardized, validated questionnaires. Descriptive statistics was performed to present patient characteristics, complication rates and functional outcome. A chi2-test for categorical and independent t-test for continuous variables was performed to identify heterogeneity between the groups and to correlate preoperative characteristics with the outcome. A P value <0.05 was considered statistically significant.ResultsPatients with higher degree of urinary incontinence (P<0.001) and risk factors such as history of pelvic irradiation (P<0.001) or prior surgery for urethral stricture (P=0.032) were more likely to receive an adjustable MS. Complication rates were comparable except for infection (P=0.009, 0 vs. 2.3%) and pain (P=0.001, 1.7% vs. 11.3%) which occurred more frequently in adjustable slings. Functional outcome according validated questionnaires demonstrated no differences between fixed and adjustable male slings.ConclusionsAdjustable male slings are more frequently utilized in patients with higher degree of incontinence and risk factors compared to fixed slings. No differences could be identified between functional outcome which may imply an advantage for adjustability. However, pain and infection rates were significantly higher in adjustable MS and should be considered in the decision process for sling type.

Dataset Information

Digital Care Program for Urinary Incontinence in Females: A Large-Scale, Prospective, Cohort Study.

Publications

Digital Care Program for Urinary Incontinence in Females: A Large-Scale, Prospective, Cohort Study.

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