Dataset Information

Comparison of Solifenacin and Bilateral Apical Fixation in the Treatment of Mixed and Urgency Urinary Incontinence in Women: URGE 1 Study, A Randomized Clinical Trial.

ABSTRACT: BACKGROUND:The aetiology of urgency urinary incontinence is a matter of debate. Current treatment options are based on the hypothesis of a neurological disorder of bladder innervation. However, it has also been hypothesised that one main cause is the reduced function of the bladder-holding apparatus, that is, insufficient suspension of the vesico-urethral junction. This study compared the effects of surgical apical vaginal elevation with those of solifenacin on urgency urinary incontinence in women. PATIENTS AND METHODS:Women with mixed and urgency urinary incontinence were randomised to either an established pharmacological arm (10 mg/day solifenacin) or the surgical arm (bilateral uterosacral ligament replacement, cervicosacropexy, CESA; or vaginosacropexy, VASA. Clinical and objective outcomes were assessed at 4 months after each type of intervention. RESULTS:The study was terminated early; 55 patients were operated on and 41 patients received pharmacological treatment. After surgical treatment, 23 patients (42%, 95% confidence intervaI=29-55%) became continent compared to four patients (10%, 95% confidence intervaI=1-19%) during solifenacin treatment. CONCLUSION:Compared to pharmacological treatment, the surgical repair of the apical vaginal end restored urinary continence in significantly more patients.

SUBMITTER: Ludwig S

PROVIDER: S-EPMC6899101 | biostudies-literature | 2019 Nov-Dec

REPOSITORIES: biostudies-literature

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Comparison of Solifenacin and Bilateral Apical Fixation in the Treatment of Mixed and Urgency Urinary Incontinence in Women: URGE 1 Study, A Randomized Clinical Trial.

Ludwig Sebastian S Becker Ingrid I Mallmann Peter P Jäger Wolfram W

In vivo (Athens, Greece) 20191101 6

<h4>Background</h4>The aetiology of urgency urinary incontinence is a matter of debate. Current treatment options are based on the hypothesis of a neurological disorder of bladder innervation. However, it has also been hypothesised that one main cause is the reduced function of the bladder-holding apparatus, that is, insufficient suspension of the vesico-urethral junction. This study compared the effects of surgical apical vaginal elevation with those of solifenacin on urgency urinary incontinen ...[more]

PMID: 31662524

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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.

Project description:Bacterial DNA and live bacteria have been detected in human urine in the absence of clinical infection, challenging the prevailing dogma that urine is normally sterile. Urgency urinary incontinence (UUI) is a poorly understood urinary condition characterized by symptoms that overlap urinary infection, including urinary urgency and increased frequency with urinary incontinence. The recent discovery of the urinary microbiome warrants investigation into whether bacteria contribute to UUI. In this study, we used 16S rRNA gene sequencing to classify bacterial DNA and expanded quantitative urine culture (EQUC) techniques to isolate live bacteria in urine collected by using a transurethral catheter from women with UUI and, in comparison, a cohort without UUI. For these cohorts, we demonstrated that the UUI and non-UUI urinary microbiomes differ by group based on both sequence and culture evidences. Compared to the non-UUI microbiome, sequencing experiments revealed that the UUI microbiome was composed of increased Gardnerella and decreased Lactobacillus. Nine genera (Actinobaculum, Actinomyces, Aerococcus, Arthrobacter, Corynebacterium, Gardnerella, Oligella, Staphylococcus, and Streptococcus) were more frequently cultured from the UUI cohort. Although Lactobacillus was isolated from both cohorts, distinctions existed at the species level, with Lactobacillus gasseri detected more frequently in the UUI cohort and Lactobacillus crispatus most frequently detected in controls. Combined, these data suggest that potentially important differences exist in the urinary microbiomes of women with and without UUI, which have strong implications in prevention, diagnosis, or treatment of UUI. Importance: New evidence indicates that the human urinary tract contains microbial communities; however, the role of these communities in urinary health remains to be elucidated. Urgency urinary incontinence (UUI) is a highly prevalent yet poorly understood urinary condition characterized by urgency, frequency, and urinary incontinence. Given the significant overlap of UUI symptoms with those of urinary tract infections, it is possible that UUI may have a microbial component. We compared the urinary microbiomes of women affected by UUI to those of a comparison group without UUI, using both high-throughput sequencing and extended culture techniques. We identified statistically significant differences in the frequency and abundance of bacteria present. These differences suggest a potential role for the urinary microbiome in female urinary health.

Dataset Information

Comparison of Solifenacin and Bilateral Apical Fixation in the Treatment of Mixed and Urgency Urinary Incontinence in Women: URGE 1 Study, A Randomized Clinical Trial.

Publications

Comparison of Solifenacin and Bilateral Apical Fixation in the Treatment of Mixed and Urgency Urinary Incontinence in Women: URGE 1 Study, A Randomized Clinical Trial.

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