Correction: Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.
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ABSTRACT:
SUBMITTER: Hall E
PROVIDER: S-EPMC11361449 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
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Correction: Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.
Hall Evelyn E Keyser Laura L McKinney Jessica J Pulliam Samantha S Weinstein Milena M
JMIR formative research 20240827
[This corrects the article DOI: 10.2196/58551.]. ...[more]
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Project description:Introduction and hypothesisTo determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users.MethodsThis is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020-December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups.ResultsOf 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22-84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2-46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified.ConclusionsThis study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.
| S-EPMC10284973 | biostudies-literature
Project description:ObjectiveThe purpose of this study was to characterize the urinary microbiota in women who are planning treatment for urgency urinary incontinence and to describe clinical associations with urinary symptoms, urinary tract infection, and treatment outcomes.Study designCatheterized urine samples were collected from multisite randomized trial participants who had no clinical evidence of urinary tract infection; 16S ribosomal RNA gene sequencing was used to dichotomize participants as either DNA sequence-positive or sequence-negative. Associations with demographics, urinary symptoms, urinary tract infection risk, and treatment outcomes were determined. In sequence-positive samples, microbiotas were characterized on the basis of their dominant microorganisms.ResultsMore than one-half (51.1%; 93/182) of the participants' urine samples were sequence-positive. Sequence-positive participants were younger (55.8 vs 61.3 years old; P = .0007), had a higher body mass index (33.7 vs 30.1 kg/m(2); P = .0009), had a higher mean baseline daily urgency urinary incontinence episodes (5.7 vs 4.2 episodes; P < .0001), responded better to treatment (decrease in urgency urinary incontinence episodes, -4.4 vs -3.3; P = .0013), and were less likely to experience urinary tract infection (9% vs 27%; P = .0011). In sequence-positive samples, 8 major bacterial clusters were identified; 7 clusters were dominated not only by a single genus, most commonly Lactobacillus (45%) or Gardnerella (17%), but also by other taxa (25%). The remaining cluster had no dominant genus (13%).ConclusionDNA sequencing confirmed urinary bacterial DNA in many women with urgency urinary incontinence who had no signs of infection. Sequence status was associated with baseline urgency urinary incontinence episodes, treatment response, and posttreatment urinary tract infection risk.
| S-EPMC4556587 | biostudies-literature
Project description: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.
| S-EPMC10815799 | biostudies-literature
Project description:The pathophysiology of Stress Urinary Incontinence (SUI) is poorly understood. The aim of this study was to identify the serum proteomic profile in patients with SUI and to replicate findings from a preceding study in which a significant difference in the urinary proteome was identified. Serum samples were collected from 38 patients (19 SUI; 19 matched, continent controls). Sample preparation included serum albumin depletion, in-solution enzymatic digestion of proteins applying a combination of Gluc-C and trypsin and peptide separation using nano High Performance Liquid Chromatography. Label-free quantitation of peptides and proteins was performed after triplicate measurements using quadrupole time-of-flight mass spectrometry. Peptide identification was achieved by searching the Human SwissProt Database using Mascot and X!Tandem. Main outcome measure was the relative abundance of each detected protein in serum.
2018-01-24 | PXD008553 | Pride
Project description:IntroductionUrinary incontinence (UI) is highly prevalent in low- and middle-income countries (LMIC). Concurrently, the availability of surgical or conservative UI treatments in LMIC is limited.MethodsWe conducted a prospective feasibility study of Belize women with UI treated with pelvic floor physical therapy (PFPT) and education (PFE). Patients received individual PFPT/PFE over 2 days, consisting of biofeedback-enhanced PFMT in addition to behavioral, dietary, and general pelvic education. Patient completed a daily 6-month home regimen including 7 PFMT exercises (total 70 repetitions) comprising both endurance and quick flick exercises. Patients also performed comprehensive dietary and behavioral modification activities. Outcomes were assessed at baseline and 6-months, including validated symptom (ICIQ-FLUTS) and QOL (IIQ-7) questionnaires, and strength testing (PERFECT score, perineometry).ResultsTwenty-eight patients underwent baseline assessment. Four patients were lost to in-person 6-month follow-up, with two of these patients completing subjective assessment only by telephone. The mean (±SD) patient age, BMI, and parity were 50.0 (±10.0) years, 33.2 (±5.8), and 2.8 (±1.5). Provider assessment demonstrated patient comprehension of basic, endurance, and quick flick pelvic floor contractions in 28 (100%), 24 (86%), and 24 (86%) patients, respectively. At 6-month follow-up, significant improvements were seen across multiple validated questionnaire and strength measurement assessments. Median patient-reported improvement level was 7.0 on a 10-point Likert scale.DiscussionStudy patients demonstrated good understanding of PFMT/PFE and program completion was associated with significant improvements across a variety of subjective incontinence and quality of life outcomes, as well as objective strength testing.
| S-EPMC10884173 | biostudies-literature
Project description:Stress urinary incontinence (SUI) is one of the pelvic floor disorders affecting tens of million of women worldwide. In general, non-surgical options have relatively limited efficacy. The most effective treatment is mid-urethral sling surgery which carries substantial risks of perioperative and postoperative complications. Regenerative therapy with the injection of several types of stem cells and stem cell products is promising but further investigation is needed before clinical implementation can be considered. In recent years, the application of microenergy therapy as a non-invasive treatment for SUI has received increasing attention. Preclinical animal studies of these models have demonstrated that low-intensity extracorporeal shockwave therapy (Li-ESWT) and microenergy acoustic pulse (MAP) therapy are capable of regenerating urethral sphincter tissue and pelvic floor muscles leading to improved urinary continence. One pilot clinical trial with Li-ESWT also reported improved quality of life in women with SUI as well as the symptoms. The objective of this review is to summarize the potential mechanisms associated with Li-ESWT and MAP therapies of SUI: (I) activation of tissue-resident stem cells; (II) regeneration of musculature in the urethra and pelvic floor; (III) improvement in biomechanical property of pelvic floor muscles; (IV) modulation of cellular signaling pathways. Further studies of the molecular mechanisms, optimal treatment dosage and schedule, and potential long-term side effects are needed to provide this non-invasive regenerative therapy for millions of women with SUI.
| S-EPMC11399057 | biostudies-literature
Project description:BackgroundThe prevalence of stress urinary incontinence (SUI) in adult female in Taiyuan and what are the related risk factors are not clear. The aim of this study was to provide a basis for exploring the prevention and treatment of SUI in adult female in Taiyuan.MethodsA voluntary online questionnaire was used to investigate adult female in the community and surrounding townships of Taiyuan. Most of the questionnaires refer to the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms, and adapt to the specific circumstances of the region. Data were analyzed using SPSS software (version 22.0).ResultsA total of 4004 eligible questionnaires were obtained. The prevalence of SUI in adult female in Taiyuan was 33.5%. Univariate analysis and multivariate logistic regression analysis showed that place of residence, smoking, body mass index, diet, number of deliveries, mode of delivery, dystocia, menopause, oral contraceptives, urinary tract infection, making the bladder empty faster by pushing down and holding urine were risk factors for adult female stress urinary incontinence in Taiyuan.ConclusionThe prevalence of SUI in adult female in Taiyuan was high, and based on risk factors identified in this survey, population-level intervention strategies should be developed for the prevention and treatment of adult female SUI in Taiyuan.
| S-EPMC8061196 | biostudies-literature
Project description:Introduction and hypothesisPrevious studies aiming to identify specific pre-defined urine protein biomarkers for stress urinary incontinence (SUI) have not identified clinically important differences. The hypothesis of our study was that the global distribution of urinary proteins, the proteome, differs between women with and those without SUI.MethodsIn this age-matched case-control study, we compared the urinary proteome of 20 women with SUI and 20 controls. Proteins were identified by applying high-performance liquid chromatography separation and tandem mass spectrometry detection. Data analysis was performed using Mascot 2.4.1 embedded in ProteinScape 3.1.ResultsWe identified 828 different proteins. The concentration of six of those showed a significant difference between urine samples of SUI patients and those of controls (q value < 0.25). Four proteins showed a higher abundance in SUI samples compared with controls: plasma serine protease inhibitor (logFC 1.11), leucine-rich alpha-2-glycoprotein (logFC 3.91), lysosomal alpha-glucosidase (logFC 1.24), and peptidyl-prolyl cis- trans isomerase A (logFC 1.96). We identified two proteins in lower abundance in SUI samples compared with controls: uromodulin (logFC -4.87) and TALPID3 (logFC -1.99).ConclusionsOverexpression of plasma serine protease inhibitor, leucine-rich alpha-2-glycoprotein, lysosomal alpha-glucosidase, and peptidyl-prolyl cis- trans isomerase A, and lower expression of uromodulin and TALPID3, in urine may be associated with female SUI.
| S-EPMC5065895 | biostudies-literature
Project description:Introduction and hypothesisMany adult women have resident urinary bacteria (urinary microbiome/microbiota). In adult women affected by urinary urgency incontinence (UUI), the etiologic and/or therapeutic role of the urinary microbiome/microbiota remains unknown. We hypothesized that microbiome/microbiota characteristics would relate to clinically relevant treatment response to UUI medication per os.MethodsAdult women initiating medication treatment orally for UUI and a comparator group of unaffected women were recruited in a tertiary care health-care system. All participants provided baseline clinical data and urine samples. Women with UUI were given 5 mg solifenacin, with potential dose escalation to 10 mg for inadequate UUI symptom control at 4 weeks. Additional data and urine samples were collected from women with UUI at 4 and 12 weeks. The samples were assessed using 16S ribosomal RNA (rRNA) gene sequencing and enhanced quantitative urine culturing. The primary outcome was treatment response as measured by the validated Patient Global Symptom Control (PGSC) questionnaire. Clinically relevant UUI symptom control was defined as a 4 or 5 score on the PGSC.ResultsDiversity and composition of the urinary microbiome/microbiota of women with and without UUI differed at baseline. Women with UUI had more bacteria and a more diverse microbiome/microbiota. The clinical response to solifenacin in UUI participants was related to baseline microbiome/microbiota, with responders more likely to have fewer bacteria and a less diverse community at baseline. Nonresponders had a more diverse community that often included bacteria not typically found in responders.ConclusionsKnowledge of an individual's urinary microbiome/microbiota may help refine UUI treatment. Complementary tools, DNA sequencing, and expanded urine culture provide information about bacteria that appear to be related to UUI incontinence status and treatment response in this population of adult women.
| S-EPMC5119460 | biostudies-literature
Project description:Introduction and hypothesisThe aim was to conduct a scoping review of the literature on the use of machine learning (ML) in female urinary incontinence (UI) over the last decade.MethodsA systematic search was performed among the Medline, Google Scholar, PubMed, and Web of Science databases using the following keywords: [Urinary incontinence] and [(Machine learning) or (Predict) or (Prediction model)]. Eligible studies were considered to have applied ML model to explore different management processes of female UI. Data analyzed included the field of application, type of ML, input variables, and results of model validation.ResultsA total of 798 papers were identified while 23 finally met the inclusion criteria. The vast majority of studies applied logistic regression to establish models (91.3%, 21/23). Most frequently ML was applied to predict postpartum UI (39.1%, 9/23), followed by de novo incontinence after pelvic floor surgery (34.8%, 8/23).There are also three papers using ML models to predict treatment outcomes and three papers using ML models to assist in diagnosis. Variables for modeling included demographic characteristics, clinical data, pelvic floor ultrasound, and urodynamic parameters. The area under receiver operating characteristic curve of these models fluctuated from 0.56 to 0.95, and only 11 studies reported sensitivity and specificity, with sensitivity ranging from 20% to 96.2% and specificity from 59.8% to 94.5%.ConclusionMachine learning modeling demonstrated good predictive and diagnostic abilities in some aspects of female UI, showing its promising prospects in near future. However, the lack of standardization and transparency in the validation and evaluation of the models, and the insufficient external validation greatly diminished the applicability and reproducibility, thus a focus on filling this gap is strongly recommended for future research.
| S-EPMC11459541 | biostudies-literature