Application of Information-Motivation-Behavioural Skills Model on Older Women with Urge Urinary Incontinence: A Retrospective Study.

BACKGROUND: Urge urinary incontinence (UUI) commonly occurs in elderly female patients. The application research of the Information-Motivation-Behavioural Skills (IMB) model has been applied in various therapeutic contexts, but research on its application in UUI management is limited. METHODS: Elderly female patients diagnosed with UUI were selected as the research subjects, and they were divided into two groups. All patients were given pelvic floor muscle training. The control group received routine health education management, whereas the observation group received health education management on the basis of the IMB model in addition to routine education. Before and after treatment, the severity of urinary incontinence was evaluated using a 1 h urine pad test. The anxiety and depression statuses were evaluated using Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS). Incontinence Quality-of-Life (I-QOL) was used to evaluate the quality of life of patients. RESULTS: After treatment, the leakage volume, SAS and SDS scores of both groups significantly decreased (p < 0.001), with the observation group having significantly lower leakage volume, SAS, and SDS scores than the control group (p < 0.001). The I-QOL scores of both groups increased (p < 0.001), and the observation group had significantly higher scores than the control group (p < 0.001). CONCLUSIONS: Health education interventions based on the IMB model can improve urinary leakage in elderly women with UUI, improve their negative emotions and enable them to have an enhanced quality of life.

Efficacy, Satisfaction, and Compliance: Insights from 15 Years of Botulinum Toxin Use for Female Urgency Urinary Incontinence.

Urgency urinary incontinence (UUI) refractory to medical treatment poses significant challenges despite advancements. This study evaluates the efficacy of intravesical botulinum toxin for UUI and identifies factors influencing treatment outcomes. Among 368 women receiving botulinum toxin injections, 74.5% achieved a complete discontinuation of pad usage. Predictors of efficacy included lower pre-treatment pad usage and the absence of prior sling placement. Patients often required repeat injections (60.3%), with younger age and satisfaction correlating with treatment repetition. The interval between injections averaged 18 months, influenced by logistical challenges and patient preferences. Despite concerns about diminishing efficacy, subjective perceptions did not align with objective findings. Limitations include retrospective analysis and heterogeneous clinical records. In conclusion, intravesical botulinum toxin is effective for UUI, with pre-treatment pad usage and sling placement history influencing outcomes and patient characteristics influencing treatment repetition.

Do peri-operative changes in voiding function and pelvic organ mobility predict improvement in urgency urinary incontinence following prolapse surgery?

OBJECTIVES: To evaluate whether peri-operative changes in voiding function, pelvic organ descent and urethral mobility predict improvement in urgency urinary incontinence (UUI) following prolapse surgery. METHODS: A retrospective study of women undergoing prolapse surgery without a history of or without a concomitant anti-incontinence surgery at a tertiary unit between 2005 and 2019. All patients underwent a pre- and post-operative standardised interview, POP-Q examination, uroflowmetry and 4D translabial ultrasound. Post processing of ultrasound volume data was performed to assess pelvic organ descent and functional urethral anatomy. RESULTS: The datasets of 123 women were analysed. Mean follow-up was 5.5 months (SD 3.2). Mean age was 61 years (SD 11.7). UUI was reported by 68 before and 44 after operation (p = 0.001 for the reduction). Among those with pre-operative UUI, 34 reported cure of UUI, 20 improvement, 9 no change and 5 worsened UUI after their operation. De novo UUI was reported in 11. Fifty-seven women reported voiding dysfunction before and 32 after operation (p = 0.09 for the reduction). Abnormal uroflowmetry was noted in 63 women before and 37 after operation (p = 0.003 for change). On binary logistic regression, improved/cured UUI was associated with improved subjective voiding function (p = 0.003) and reduced residual urine volume (p = 0.02), but not with peri-operative changes in pelvic organ descent or functional urethral anatomy. CONCLUSION: Prolapse surgery resulted in short- to medium- term improvement in UUI. This was associated with subjective improvement in voiding function and with a reduction in post-void residual urine volume. SUMMARY: Prolapse surgery was associated with improvement in UUI which in turn was associated with subjectively improved voiding and reduced residual urine volume.

Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy. METHODS: A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests. RESULTS: Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m2); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores. CONCLUSIONS: In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a ß-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.

Effects of external neuromuscular electrical stimulation in women with urgency urinary incontinence: a randomized sham-controlled study.

BACKGROUND AND PURPOSE: The present study aims to investigate the effects of external neuromuscular electrical stimulation (NMES) on urinary symptoms, pelvic floor muscle strength (PFMS), quality of life (QoL), sexual function, perception of subjective improvement (PSI), and satisfaction in urgency urinary incontinence (UUI). MATERIALS AND METHODS: The randomized sham-controlled study design was employed in this study. Women aged 18-65 years, who were diagnosed with UUI, were randomly allocated into the NMES (external NMES + lifestyle advice, n = 15) and sham groups (sham NMES + lifestyle advice, n = 15). Both groups performed the application for 30 min, three days a week for eight weeks. Urinary symptoms were evaluated by using the International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and a 3-day bladder diary. PFMS was assessed using the Modified Oxford Scale (MOS), QoL using the King's Health Questionnaire (KHQ), and sexual function using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). The PSI and satisfaction were questioned. RESULTS: There was a higher level of decrease in the ICIQ-SF score, the mean number of voids/night and UI, all scores related to the KHQ (excluding interpersonal relationships), and a higher level of increase in maximum voiding volume, MOS scores, PISQ-12-emotional, PISQ-12-physical, and PISQ-12-total scores in the NMES group when compared to the sham group (p < 0.05). PSI and satisfaction were at higher levels in the NMES group than in the sham group (p < 0.05). CONCLUSIONS: External NMES was an effective and complementary method in reducing urinary symptoms and improving PFMS, QoL, sexual function, PSI, and satisfaction level in women with UUI. CLINICAL TRIAL REGISTRATION: NCT04727983.

Risk Factors of Pelvic Floor Disorders Among Women in Rural Nepal: A Case-Control Study.

INTRODUCTION AND HYPOTHESIS: Risk factors for pelvic floor disorders (PFDs) are not well understood in lower resource settings. The objective of this study is to determine the risk factors associated with stress urinary incontinence (SUI), urge urinary incontinence (UUI), and pelvic organ prolapse (POP) among women of reproductive age in rural Nepal. METHODS: This is a case-control study nested within a community-based cross-sectional survey of parous women of reproductive age with PFDs in the Sarlahi District of Nepal. The presence of PFDs was confirmed by clinical assessment. Detailed sociodemographic information and histories were captured. RESULTS: We examined 406 women; the mean (SD, range) age was 32.7 (8.5, 16-49) years, mean BMI (SD) was 19.7 (3.3) kg/m2, and median (range) number of pregnancies was 4 (1-11). Two hundred and three women (50.0%) had either SUI or UUI, 85 (17.8%) had both SUI and UUI, and 71 (17.5%) had POP at or beyond the hymen. After controlling for other variables significant on bivariate analysis, age (adjusted odds ratio [aOR] 1.06 [95% CI 1.03-1.09]), illiteracy (aOR 2.24 [95% CI 1.04-4.80]), and presence of upper gastrointestinal issues (aOR 3.30, [95% CI 1.77-6.16]) were independently associated with SUI/UUI. Age (aOR 1.05 [95% CI 1.02-1.09]), bispinous diameter (aOR 2.88 ([95% CI 1.11-7.47]), and subpubic angle (aOR 2.78 [95% CI 1.55-5.03]) were independently associated with POP. CONCLUSION: Risk factors for PFDs in a homogenous community of parous women of reproductive age in rural Nepal are similar to those found in parous women in higher income countries.

Urinary microbiome community types associated with urinary incontinence severity in women.

BACKGROUND: Urinary microbiome (urobiome) studies have previously reported on specific taxa and community differences in women with mixed urinary incontinence compared with controls. Therefore, a hypothesis was made that higher urinary and vaginal microbiome diversity would be associated with increased urinary incontinence severity. OBJECTIVE: This study aimed to test whether specific urinary or vaginal microbiome community types are associated with urinary incontinence severity in a population of women with mixed urinary incontinence. STUDY DESIGN: This planned secondary, cross-sectional analysis evaluated associations between the urinary and vaginal microbiomes and urinary incontinence severity in a subset of Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial participants with urinary incontinence. Incontinence severity was measured using bladder diaries and Urinary Distress Inventory questionnaires collected at baseline. Catheterized urine samples and vaginal swabs were concurrently collected before treatment at baseline to assess the urinary and vaginal microbiomes. Of note, 16S rRNA V4 to V6 variable regions were sequenced, characterizing bacterial taxa to the genus level using the DADA2 pipeline and SILVA database. Using Dirichlet multinomial mixtures methods, samples were clustered into community types based on core taxa. Associations between community types and severity measures (Urinary Distress Inventory total scores, Urinary Distress Inventory subscale scores, and the number of urinary incontinence episodes [total, urgency, and stress] from the bladder diary) were evaluated using linear regression models adjusted for age and body mass index. In addition, alpha diversity measures for richness (total taxa numbers) and evenness (proportional distribution of taxa abundance) were analyzed for associations with urinary incontinence episodes and community type. RESULTS: Overall, 6 urinary microbiome community types were identified, characterized by varying levels of common genera (Lactobacillus, Gardnerella, Prevotella, Tepidimonas, Acidovorax, Escherichia, and others). The analysis of urinary incontinence severity in 126 participants with mixed urinary incontinence identified a Lactobacillus-dominated reference group with the highest abundance of Lactobacillus (mean relative abundance of 76%). A community characterized by fewer Lactobacilli (mean relative abundance of 19%) and greater alpha diversity was associated with higher total urinary incontinence episodes (2.67 daily leaks; 95% confidence interval, 0.76-4.59; P=.007) and urgency urinary incontinence episodes (1.75 daily leaks; 95% confidence interval, 0.24-3.27; P=.02) than the reference group. No significant association was observed between community type and stress urinary incontinence episodes or Urogenital Distress Inventory total or subscores. The composition of vaginal community types and urinary community types were similar but composed of slightly different bacterial taxa. Vaginal community types were not associated with urinary incontinence severity, as measured by bladder diary or Urogenital Distress Inventory total and subscale scores. Alpha diversity indicated that greater sample richness was associated with more incontinence episodes (observed genera P=.01) in urine. Measures of evenness (Shannon and Pielou) were not associated with incontinence severity in the urinary or vaginal microbiomes. CONCLUSION: In the urobiome of women with mixed urinary incontinence, a community type with fewer Lactobacilli and more diverse bacteria was associated with more severe urinary incontinence episodes (total and urgency) compared with a community type with high predominance of a single genus, Lactobacillus. Whether mixed urinary incontinence severity is due to lesser predominance of Lactobacillus, greater presence of other non-Lactobacillus genera, or the complement of bacteria consisting of urobiome community types remains to be determined.

Association Between Added Sugar Intake and Urinary Incontinence in Females: A Cross-sectional Population-based Study.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence (UI) is a widespread issue in women that severely impacts quality of life. The addition of sugar is associated with multiple adverse effects on health. This study examined the potential association between added sugar intake and UI. METHODS: Adult females from the National Health and Nutrition Examination Survey database (2005-2018) were included in this study. The primary outcomes were the prevalence of stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence (MUI). Weighted logistic regression, stratified logistic regression, restricted cubic spline regression, and sensitivity analyses were utilized to determine whether added sugar was associated with UI after multivariate adjustment. RESULTS: A total of 14,927 participants met the inclusion criteria. The results revealed a heightened prevalence of SUI, UUI, and MUI in the fourth quartile of added sugar energy percentage (OR = 1.304, 95% confidence interval [CI] = 1.105-1.539; OR = 1.464, 95% CI = 1.248-1.717; OR = 1.657, 95% CI = 1.329-2.065 respectively). The effect was more pronounced in young women and the subgroup analyses did not reveal any noteworthy interaction effects. According to the sensitivity analyses, the results for SUI and the MUI were consistent with those of the primary analyses. CONCLUSIONS: The excessive intake of added sugar among women may increase their risk of SUI and MUI. Our study highlights the negative effects of added sugar on female genitourinary health and highlights the need for universal access to healthy diets.

Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices.

The tibial nerve is an established target for neuromodulation in the management of overactive bladder (OAB) and its associated symptoms, including urge urinary incontinence (UUI). Technologies are currently available to deliver tibial nerve stimulation (TNS) through percutaneous devices or through implantable devices. The benefits and safety of percutaneous TNS have led to it as a guideline-recommended therapy. However, patient compliance is limited by the burden of weekly office visits and the need for maintenance treatments. Further, insurance often only covers a limited number of lifetime visits for percutaneous TNS. These factors and others have led to the development, study, and utilization of implantable TNS devices. Implantable TNS devices deliver the same therapeutic mechanism of action for nerve stimulation with a permanent implanted device that provides at-home stimulation rather than in-office therapy delivery. Additionally, there is an added potential for dynamic and patient-centered stimulation. There is a large body of high-quality evidence published for TNS, including numerous randomized controlled trials published on percutaneous TNS which have consistently demonstrated superior efficacy to sham and similar efficacy to that of anticholinergic medications. Percutaneous TNS also performs better than conservative therapy including pelvic floor muscle training. The percutaneous and implantable approaches deliver nerve stimulation to the same target nerve, using the same mechanism of action. Therefore, data from randomized trials of percutaneous TNS are informative for implantable TNS devices. At the time of this article's publication, at least two implantable TNS devices have received marketing authorization from the Food and Drug Administration (FDA). The objective of this review is to discuss the mechanism of action for TNS and summarize the published literature from clinical trials of percutaneous TNS as a foundation of high-quality evidence for implantable devices targeting the tibial nerve.

Association of diarrhea or constipation with urinary incontinence in adults: A cross-sectional analysis of the National Health and Nutrition Examination Survey.

AIMS: This study aimed to investigate the association between diarrhea or constipation and urinary incontinence (UI) in adults. METHODS: Data from the National Health and Nutrition Examination Survey for 2009-2010 was used to include 4686 adults aged 20 and over in the analysis. Stress urinary incontinence (SUI) and urgency urinary incontinence (UUI) were used as outcome variables, with diarrhea and constipation as exposure factors. We first compared the baseline characteristics of those with and without SUI, as well as those with and without UUI. The impact of diarrhea or constipation on SUI and UUI was assessed using multivariate logistic regression models. To ensure the stability of the results, subgroup and stratified analyses were conducted. RESULTS: The prevalence rates of UUI and SUI were 22.49% and 23.39%, respectively. Adjusted multivariate logistic regression analysis revealed that the risk of UUI was increased by either diarrhea (OR 1.66, 95% CI 1.36-2.04) or constipation (OR 1.42, 95% CI 1.11-1.83). The risk of SUI was also elevated by either diarrhea (OR 1.36, 95% CI 1.11-1.67) or constipation (OR 1.32, 95% CI 1.06-1.63). Subgroup analysis revealed no significant differences in the interaction tests between constipation or diarrhea and UI. CONCLUSIONS: This study found that both constipation and diarrhea increase the risk of UUI and SUI.

Prevalence of stress urinary incontinence and urge urinary incontinence in multiples sclerosis patients: a systematic review and meta-analysis.

Urinary incontinence (UI), encompassing stress urinary incontinence (SUI) and urge urinary incontinence (UUI), is a prevalent and debilitating condition in patients with multiple sclerosis (MS), profoundly impacting their quality of life. This systematic review and meta-analysis aimed to elucidate the worldwide prevalence rates of SUI and UUI among MS patients. This study was conducted by examining observational studies published between 2000 and 2023. An exhaustive literature search was conducted across databases such as PubMed, MEDLINE, Web of Science, Scopus, ProQuest, and Google Scholar. The Meta-prop method facilitated pooled prevalence estimation of UUI and SUI, while Egger tests assessed publication bias. In total, 27 studies with 15,052 participants were included in the meta-analysis. The findings revealed a high random effect pooled prevalence of UUI at 41.02% (95% Confidence Interval [CI]: 30.57-51.89; I2 = 99%, p < 0.001) and SUI at 25.67% (95% CI: 19.30-32.58%; I2 = 94.9%, P < 0.001). Additionally, the pooled prevalence of mixed urinary incontinence (MUI) was reported at 18.81% (95% CI: 7.55-33.48; I2:95.44%, p < 0.001). The high heterogeneity observed suggests variable prevalence across populations and highlights the intricate nature of UI in MS. These findings underscore the critical need for dedicated supportive, therapeutic, and rehabilitative interventions to manage this common complaint in MS patients effectively.

Associated factors of stress, urgency, and mixed urinary incontinence in a geriatric outpatient assessment of older women with hip fracture.

PURPOSE: Urinary incontinence (UI) is known to be common among older female hip fracture patients. Little is known about different subtypes of UI among these patients. Our aim was to identify factors associated with subtypes of UI in a cross-sectional design. METHODS: 1,675 female patients aged ≥ 65 and treated for their first hip fracture in Seinäjoki Central Hospital, Finland, during 2007-2019, were included in a prospective cohort study. Of these, 1,106 underwent comprehensive geriatric assessment (CGA), including questions on continence, at our geriatric outpatient clinic 6 month post-fracture. A multivariable-adjusted multinomial logistic regression model was used to examine factors associated with UI subtypes. RESULTS: Of the 779 patients included, 360 (46%) were continent and 419 (54%) had UI 6-month post-fracture. Of the women with UI, 117 (28%) had stress UI, 183 (44%) had urgency UI and 119 (28%) had mixed UI, respectively. Mean age of the patients was 82 ± 6,91. In multivariable analysis, depressive mood and poor mobility and functional ability were independently associated with stress UI. Fecal incontinence (FI) and Body Mass Index (BMI) over 28 were independently associated with urgency UI. Mixed UI shared the aforementioned factors with stress and urgency UI and was independently associated with constipation. CONCLUSIONS: Mixed UI was associated with most factors, of which depressive mood and impaired mobility and poor functional ability were shared with stress UI, and FI and higher BMI with urgency UI. CGA is key in assessing UI in older hip fracture patients, regardless of subtype.

Outcomes of para-sacral transcutaneous electric nerve stimulation in treatment of primary and refractory overactive bladder among children.

BACKGROUND: Overactive bladder (OAB) is the most prevalent lower urinary tract dysfunction among children. Refractory OAB lacks response to the first line treatments, including anticholinergic, and it is a major clinical challenge. This study aims to compare the efficacy of para-sacral transcutaneous electric nerve stimulation (PS-TENS) in the treatment of primary and refractory OAB among children. METHODS: A prospective, randomized clinical study included 64 children aged 5-12 years with OAB divided equally into two groups: group (1) included 32 children with treatment-naive OAB, while group (2) included 32 children with refractory OAB who failed complete course of anticholinergics. Both groups received PS-TENS three times weekly for 12 weeks. Detailed medical history, voiding diary, ultrasound, and uroflowmetry with EMG were performed at baseline and after 12 weeks of treatment. Filling cystometry was performed for children with refractory OAB before and after PS-TENS. RESULTS: After the end of treatment the number of children with urge incontinence decreased significantly among the two groups: from 25 to 13 and 27 to 15 for the primary and refractory groups, respectively. Micturition frequency per 24 h decreased significantly among children with primary OAB. Bladder capacity increased significantly and the resting detrusor pressure decreased significantly among children with refractory OAB. CONCLUSIONS: PS-TENS is an effective and safe treatment option for children with OAB. The magnitude of improvement is higher among children with primary as compared to refractory OAB.

Predictive factors of post-HoLEP incontinence: differences between stress and urgency urinary incontinence.

INTRODUCTION: The analysis of post-HoLEP urinary incontinence (UI) has traditionally focused on stress UI. Our aim is to evaluate the factors associated with stress and urgency UI in the first month after the surgery. METHODS: Data were obtained from patients who underwent HoLEP by the same experienced surgeon. UI was evaluated at one month and at 6 months after the surgery. Three groups were defined: continent patients, patients with pure urgency UI and patients with stress or mixed UI. Preoperative, intraoperative, urodynamic and clinical variables were analyzed and compared between the three groups. RESULTS: In total, 235 subjects were included. One month after the surgery, 156 (66.5%) were continent (group 1), 49 (20.8%) reported pure urgency UI (group 2), and 30 (12.7%) reported some level of stress UI (group 3). In Group 2, the factors associated with urgency UI in the univariate analysis were age, presurgical urgency UI, having diabetes or hypertension. In Group 3, age, prostatic volume, preoperative PSA, time of enucleation, weight of the resection in grams, having an IDC or being diabetic were significant in the univariate analysis. In the multivariate analysis, age predicts both types of UI, while prostatic volume and having an IDC predict stress or mixed UI. CONCLUSION: In the first month post-HoLEP, age is a predictive factor of urgency UI and stress UI. In addition, prostatic volume and the presence of an indwelling urinary catheter are predictive factors of stress UI.

Associations Between Serum Estrogen Levels and Urinary Incontinence in Women: A Cross-sectional Analysis of NHANES 2013 to 2016.

OBJECTIVE: To explore the relationship between serum estrogen levels and urinary incontinence in a nationally representative female population. MATERIALS AND METHODS: We included women who had serum estradiol measurements and self-reported urinary incontinence problems in the 2013-2016 National Health and Nutrition Examination Survey cycles. A weighted multivariable logistic regression model was used to determine the association between urinary incontinence and serum estrogen levels after adjusting for age, race, Body Mass Index, diabetes, venipuncture, hypertension, poverty-to-income ratio, smoking, marital status, alcohol use, education, and menopause. RESULT: A total of 4114 individuals were ultimately included in our study. Of these women, 1200 (29.17%) complained of urge urinary incontinence (UUI), 1674 (40.69%) complained of stress urinary incontinence (SUI), 730 (17.74%) complained of mixed urinary incontinence (MUI). Women in the lowest quartile of serum estrogen were more likely to complain of UUI compared to those in the highest quartile (OR=1.885; 95% CI=1.042-3.412, P = .039). No association was noted between serum estrogen levels and SUI or MUI. CONCLUSION: Our study shows a significant association between low serum estrogen level and the increased likelihood of UUI in women. Further research is required to validate our findings, elucidate the physiological mechanisms that underlie them, and assess potential therapeutic implications.

A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Urodynamic insights: exploring the relationship between detrusor overactivity and pelvic organ prolapse in women with urge incontinence.

PURPOSE: Pelvic organ prolapse (POP) and overactive bladder (OAB) commonly affect the aging female population. We aimed to investigate the possible relationship between the two, as reflected by urodynamic studies. METHODS: A retrospective analysis was conducted on women who underwent urodynamic studies at a university-affiliated tertiary medical center from January 2018 to January 2021. Women presenting with urge incontinence and diagnosed with detrusor overactivity (DO) were included in the study. Based on the presence or absence of a modified POP-Q ≥ grade 2, these women were categorized into two groups. Data on general demographics, clinical symptoms, and urodynamic findings were extracted and compared using SPSS. RESULTS: During the study period, 949 urodynamic evaluations were performed. Of these, 303 (31.92%) reported urge incontinence. Out of this subset, 151 (49.83%) were diagnosed with DO. Within this group, 18 (11.9%) had POP, while 134 (88.1%) did not. The POP group had a notably higher incidence of prior vaginal hysterectomy and anterior colporrhaphy (p = 0.02 and p = 0.01, respectively). While most urodynamic parameters were similar between groups, there was a significant increase in hesitancy in the POP group (13 s vs 8 s, p = 0.03). There was a trend indicating a reduced median Q max (12 ml/s vs. 18 ml/s, p = 0.06) and an increased flow time (55 s vs 40 s, p = 0.08) in the POP group. CONCLUSION: The urodynamic profile of the POP group suggests an obstructive voiding pattern. Further longitudinal research is essential to fully understand the relationship between POP and OAB.

Joint Effect of Physical Activity and Sedentary Behavior with the Female Urinary Incontinence: An Analysis of NHANES 2011-2016.

INTRODUCTION: Our study aimed to assess the independent and joint effects of leisure-time physical activity and sedentary behavior with urinary incontinence (UI). METHODS: Data were obtained from the National Health and Nutrition Examination Survey 2011-2016. The primary endpoint was the risk of different subtypes of UI, including stress UI, urgency UI, and mixed UI. The primary exposures were leisure-time physical activity and sedentary behavior. Sedentary behavior was assessed by screen time. Weighted univariate and multivariate logistic regression models were used to observe the independent and joint relationship of leisure-time physical activity and sedentary behavior with UI risk (including stress UI, urgency UI, and mixed UI). RESULTS: In total, 6,927 female participants were included in this analysis. 3,377 females did not have UI, 1,534 had stress UI, 836 had urgency UI, and 1,180 had mixed UI. Screen time with ≥5 h/day was associated with increased odds of urgency UI (odds ratio [OR] = 1.31, 95% confidence intervals (CI): 1.06-1.61), which indicated the relationship of sedentary behavior and urgency UI. Engaging in leisure-time physical activity with of ≥750 metabolic equivalent (MET)·min/week was found to be significantly associated with reduced likelihood of mixed UI (OR = 0.68, 95% CI: 0.55-0.85). Additionally, the interaction term of leisure-time physical activity<750 MET·min/week and screen time ≥5 h/day was observed to be linked with increased odds of urgency and mixed UI. CONCLUSION: Participants experiencing a lower level of leisure-time physical activity and a higher level of sedentary behavior together might enhance the urgency and mixed UI risk.

Synthetic vs nonsynthetic slings for female stress and mixed urinary incontinence: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to systematically review objective and subjective success and surgical outcomes of suburethral sling surgery for female patients with stress or mixed urinary incontinence using synthetic vs nonsynthetic material with corresponding surgical approaches (retropubic or transobturator). DATA SOURCES: We systematically searched Medline, Embase, EBM Reviews, ClinicalTrials.gov, and Web of Science Core Collection using standardized Medical Subject Headings (MeSH) without date restrictions (PROSPERO-registered). We double-screened studies and used backward citation chaining. STUDY ELIGIBILITY CRITERIA: We included peer-reviewed randomized controlled trials and prospective or retrospective comparative studies examining outcomes of retropubic or transobturator synthetic vs nonsynthetic (autologous, allograft, or xenograft) slings for female stress or mixed urinary incontinence, with available English or French full texts. We excluded minislings (single insertion point). We allowed slings for recurrent stress or mixed urinary incontinence, and slings concomitant with prolapse surgery, with at least 6 weeks of postoperative follow-up. We excluded systematic reviews, meta-analyses, review studies, case-control studies, case reports, studies that did not describe surgical approach or material, and studies of combination slings. METHODS: We evaluated study quality using RoB, the Cochrane risk-of-bias tool for randomized controlled trials, and the Newcastle-Ottawa scale for observational studies. We used pooled relative risk with 95% confidence intervals to estimate the effect of sling material type on each outcome through meta-analysis and meta-regression, as appropriate. RESULTS: We screened 4341 abstracts, assessed 104 full texts, and retained 35 articles (30 separate studies). For retropubic synthetic vs nonsynthetic slings, there was no difference in the number of objectively or subjectively continent patients. The rates of reoperation for stress urinary incontinence and overall were higher with nonautologous retropubic slings than with synthetic slings. Compared with autologous slings, retropubic synthetic slings were associated with higher subjective continence in populations with ≥25% recurrent stress urinary incontinence (relative risk, 1.27; 95% confidence interval, 1.12-1.43). There were no differences in continence between transobturator synthetic and nonsynthetic slings. Subjective satisfaction was better in the transobturator synthetic group than in the autologous sling group (relative risk, 1.42; 95% confidence interval, 1.03-1.94). CONCLUSION: Synthetic and nonsynthetic slings have comparable objective and subjective success, with synthetic materials generally showing better operative outcomes and fewer complications.