Treatment Of Urge Urinary Incontinence Research Articles

167 - Two-year Follow-up of Revi™ Therapy, Implantable Tibial Neuromodulation (iTNM) for the Treatment of Urinary Urge Incontinence: The OASIS Study

167 - Two-year Follow-up of Revi™ Therapy, Implantable Tibial Neuromodulation (iTNM) for the Treatment of Urinary Urge Incontinence: The OASIS Study

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

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. 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. 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. 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. 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.

Impact of microbiota and host immunologic response on the efficacy of anticholinergic treatment for urgency urinary incontinence.

Studies within the past decade have suggested associations among composition of the urinary microbiota, local immune responses, and urinary incontinence symptoms. To investigate these relationships, we evaluated the structure of the urinary microbiome, local inflammatory markers, and patient responses prior to and at 6-weeks after treatment with anticholinergic medication for urgency urinary incontinence (UUI). Using a prospective pilot study, we enrolled women who presented with UUI symptoms and were prescribed treatment with anticholinergics. Catheterized urine samples were collected from participants at their baseline and 6-week follow-up visits for microbiological (standard and 16S rRNA gene phylotyping analyses) and cytokine analysis along with the UDI-6 questionnaire and 2-day bladder diary. Patients were Caucasian, post- menopausal, with a median age of 64 and median BMI of 30.1kg/m2. Among the patients, 75% had UUI symptoms for less than 2years, but with a frequency of at least a few times a week or every day. Most women were prescribed 10mg oxybutynin ER daily at enrollment. Patients had varied urinary microbiota by culture and 16S phylotyping, with species of Lactobacillus being the most common, in six samples, in addition to taxa associated with Enterococcus, Staphylococcus, and mixed flora. Cytokine levels showed no differences before and after treatment with anticholinergics, nor correlation with urinary bacteria or microbiome composition. Our pilot study suggests factors in addition to the urinary microbiome and local immune responses may be involved in patients' response to anticholinergics for UUI.

Use of a Computerized Decisional Analysis Tool in Patients With Urgency Urinary Incontinence.

Decision analysis tools (DAT) are shared decision making instruments that include patient input on treatment goals and values that have been shown to decrease decisional regret in women's health care. We describe a novel, computerized DAT for patients with urinary incontinence (UI), and our primary aim was to assess the concordance between treatment fit as determined by the DAT and treatment selected after physician counseling in patients with urgency urinary incontinence and urgency predominant mixed urinary incontinence. We partnered with a health care startup to develop a computerized DAT incorporating evidence about UI and patient input about treatment goals and personal values. This is a retrospective cohort study examining the concordance of DAT-predicted treatments identified before consultation with the physician and those chosen after counseling. Electronic medical records were reviewed to abstract demographic, clinical data, and treatments chosen at the initial physician consultation. Because it was possible to pursue concurrent treatment options (ie, pelvic floor physical therapy and medications), the first 2 modalities identified in the treatment plan at consultation were abstracted. Descriptive statistics were conducted using SPSS®, we did not adjust for multiple comparisons. Four hundred eighty-nine patients met the inclusion criteria for our study, and 65% of the cohort chose treatment options after counseling that were concordant with their DAT best treatment fit. Patients choosing treatment for urgency urinary incontinence and urgency predominant mixed urinary incontinence using a novel, computer-based DAT to prepare for shared decision making with their physicians often choose to proceed with their top DAT-determined treatment fit after counseling.

Clinical Practice Guidelines: Rehabilitation Interventions for Urgency Urinary Incontinence, Urinary Urgency, and/or Urinary Frequency in Adult Women

Background/Rationale: The body of evidence for interventions specific to urgency urinary incontinence (UUI), urinary urgency, and/or urinary frequency is not as readily accessible to consumers or health care providers when compared with stress urinary incontinence. This clinical practice guideline (CPG) is presented to help inform readers of the current evidence for physical therapy intervention of UUI, urinary urgency, and/or urinary frequency, as well as identify the areas in which further research is needed. Purpose of the CPG: The aim of this CPG is to provide evidence-based recommendations for rehabilitation interventions of UUI, urinary urgency, or urinary frequency in adult women. Methodology: Five electronic databases (OVID Medline, EMBASE, Cochrane Library, CINAHL, and ProQuest) were used to search for scientific literature published from January 1, 1995, to June 30, 2017. Critical readers formally assessed the procured articles. The authors collaborated to establish the levels of evidence and create the recommendations. Results: Thirty-one articles informed the development of 7 of the recommendations for intervention of UUI, urinary urgency, and/or urinary frequency. Summary tables of the articles that support each of the recommendations are presented. Two additional recommendations for best practice are presented as expert opinion. Conclusion: The CPG offers guidance to health care providers and patients for the treatment of urinary urge incontinence, urinary urgency, and urinary frequency. Recommendations, in order of strength of evidence, include behavioral interventions and pelvic floor muscle training (grade A) followed by electrical stimulation (grade B), and then lifestyle modifications (grades B and C). See the Supplemental Digital Content Video Abstract, available at: http://links.lww.com/JWHPT/A115.

Treating and Managing Urinary Incontinence: Evolving and Potential Multicomponent Medical and Lifestyle Interventions.

Incontinence is defined by either ICS 2002 or IUGA/ICS 2010 as the involuntary loss of urine and includes urgency urinary incontinence (UUI), stress urinary incontinence (SUI) or mixed urinary incontinence (MUI). It has a high worldwide prevalence with an associated impact on quality of life. Despite existing management options for the management of urinary incontinence, patients continue to be troubled by symptoms or side effects of existing treatment. There is therefore a requirement for ongoing research into treatment options for the management of UUI and SUI, that are more effective and tolerable to patients. Advances in treatment of UUI include a more selective beta 3 agonist, Vibegron, which has less impact on cardiac function than Mirabegron. Hormonal treatment, including Ospemifene and Prasterone, may improve GSM and in turn symptoms of UUI. There are advances in the types of neuromodulators available, including those that are rechargeable at home and are MRI safe. Laser has shown promising initial results. There is developing interest in the microbiome, and how this may impact future treatment modalities. Advances in treatment of SUI include the use of mobile health applications to support delivery of pelvic floor muscle training. Litoxetine, a selective serotonin reuptake inhibitor, has shown promising results at phase III trials. Functional magnetic stimulation is being developed to improve contractility of pelvic floor muscles. We also discuss interventions that improve tissue elasticity and regeneration, such as platelet rich plasma, autologous stem cell transplantation, laser therapy and radiofrequency treatment, which show short term benefits.

The effect of solifenacin treatment for urge urinary incontinence on sexual function in premenopausal and postmenopausal women: a prospective observational study

Purpose: The aim of this study is to determine whether solifenacin used for urge urinary incontinence improves sexual function and if so this improvement differs between premenopausal and postmenopausal women.
 Materials and Methods: 120 women, 48 premenopausal and 72 postmenopausal were enrolled in the study. They filled out the Female Sexual Function Index (FSFI) before, three months, and six months after the solifenacin 5mg daily treatment for urge urinary incontinence. The results were interpreted in two groups, premenopausal and postmenopausal. The FSFI scores for baseline and for post-treatment were compared for both groups and with each other.
 Results: All domains of FSFI except orgasm were improved with the use of Solifenacin. The mean FSFI scores following three months (n=110) and six months (n=65) of solifenacin treatment are significantly improved compared to the baseline in both premenopausal and postmenopausal patients. This improvement in FSFI scores does not significantly differ between premenopausal and postmenopausal groups.
 Conclusion: Solifenacin treatment for lower urinary tract symptoms has been shown to have a positive impact on the sexual functions of both premenopausal and postmenopausal women. Although treatment with solifenacin improved sexual dysfunction in women, this improvement did not vary between premenopausal and postmenopausal women.

PROPOSAL FOR A CLINICAL PROTOCOL FOR THE CONSERVATIVE TREATMENT OF URGE URINARY INCONTINENCE

Objective: To present a proposal for a clinical protocol for the conservative treatment of urge urinary incontinence. Method: Experience report based on existing scientific evidence and clinical experience of authors who perform nursing consultations for people with urge urinary incontinence, outlined in accordance with the Brazilian Ministry of Health’s proposal for the elaboration of clinical protocols. Results: A clinical protocol was proposed with nursing diagnosis and interventions based on the North American Nursing Diagnosis Association (NANDA) and Nursing Interventions Classifications (NIC), with systematized steps to verify the presence of related factors or conditions associated with the diagnosis, namely: hyperactive pelvic floor, anxiety, constipation, urinary tract infection, low fluid intake, inadequate sanitary behavior, diabetes mellitus, pelvic organ prolapse, high consumption of potential bladder irritants and persistence of symptoms. Soon after, the actions that should be implemented by the nurse were described in detail. Conclusion: It is considered that the flow and detailing of the actions presented can be adopted by nurses in order to identify and treat people with urge urinary incontinence, thus minimizing the prevalence of the problem and promoting the quality of life of these people.

Changes in brain response to urgency before and after treatment of urgency urinary incontinence with onabotulinumtoxin A

To better understand the role of the brain in urgency urinary incontinence (UUI), we used onabotulinumtoxin A (BoNTA) as a probe to evaluate changes in the brain's response to urgency in successful and unsuccessful treatment. Because BoNTA acts peripherally, brain changes observed should represent a reaction to changes in bladder function caused by BoNTA, or changes in the brain's compensatory mechanisms, rather than a direct effect of BoNTA on the brain. We recruited 20 women aged over 60 years with nonneurogenic UUI who were to undergo treatment with onabotulinum A toxin injected intravesically. We performed a baseline evaluation which included a 3-day bladder diary and functional magnetic resonance imaging with an urgency provocation task; we repeated this evaluation 6 weeks posttreatment. We performed ananalysis of variance on a priori selected regions of interest and post hoc voxel-wise analysis on responders and nonresponders to treatment. We found a significant interaction in the right insula [F(1,18) = 5.5, p = 0.031]; activity was different during urgency provocation in responders and non-responders to therapy, before and after therapy. The supramarginal gyrus (SMG) and inferior frontal gyrus (IFG) also displayed significant interactions (p < 0.005). Activity in the periaqueductal gray and prefrontal cortex was correlated with number of leakage episodes (p < 0.05). The changes seen in the brain control mechanism after therapy likely reflect reduced bladder sensation caused by BoNTA's peripheral action. We ascribe the SMG and IFG changes to a coping mechanism for urgency which is reduced in those who respond well to treatment.

Efficacy and safety of propiverine in patients with overactive bladder and neurogenic detrusor overactivity

Purpose: The purpose of this review is to evaluate the efficacy and safety of propiverine in pediatric and adult patients, which is used in the symptomatic treatment of urgency urinary incontinence and urinary frequency and/or urinary incontinence in patients with neurogenic detrusor overactivity due to overactive bladder or spinal cord injuries. Method: Literature was retrieved by a PubMed search, using different combinations of pertinent keywords (e.g., propiverine, overactive bladder, neurogenic detrusor overactivity), without any limitations in terms of the publication date and language. Papers that assessed the therapeutic efficacy and tolerability of propiverine in patients with overactive bladder or neurogenic detrusor overactivity were selected for inclusion according to their relevance for the topic, as judged by the authors. Results: Propiverine is reported to be a significantly effective and safe treatment option in adult and pediatric patients with overactive bladder or neurogenic detrusor overactivity. It is observed that propiverine provides an increase in life quality without affecting cognitive functions, and may be a safe treatment option, except for patients with angleclosure glaucoma, who have not been examined in terms of ophthalmological reliability. It was observed that no changes were observed in cardiac parameters in patients receiving propiverine treatment, and there was no clinically significant difference in the incidence of side effects between the two groups in studies comparing elderly and young patients. Propiverine is recommended by the pediatric committee at the International Incontinence Consultation with the highest level of evidence (1B/C) of all anticholinergics. Conclusion: Propiverine is an effective and safe treatment option that can be the first choice in the symptomatic treatment of both adult and pediatric patients with overactive bladder or neurogenic detrusor overactivity, with its high efficacy and significantly higher tolerability

Symptom improvement with mirabegron treatment is associated with urobiome changes in adult women

Introduction and hypothesisMirabegron, a beta-3 agonist, is prescribed for urgency urinary incontinence (UUI). We assessed the correlation of symptom improvement with urobiome characteristics in adult women participants prescribed mirabegron for UUI treatment.MethodsWe enrolled participants seeking UUI treatment who selected mirabegron and agreed to participate in this 12-week, open label study conducted at the Female Pelvic Medicine and Reconstructive Surgery Center at Loyola University Medical Center. Following eligibility screening and research consent, participants completed the overactive bladder questionnaire (OAB-Q) and provided a catheterized urine sample at baseline, 4, 8, and 12 weeks. The primary outcome, symptom improvement at 12 weeks, was based on the validated Patient Global Symptom Control questionnaire score to dichotomize symptom response (responder vs nonresponder [PGSC score ≤3]). Urine samples were processed by the Expanded Quantitative Urine Culture (EQUC) protocol.ResultsEighty-three participants (mean age 68 years) completed baseline assessment. Of the 47 participants with primary outcome data and samples analysis, there were 16 responders and 31 nonresponders; responder groups were similar demographically. Living microbes were detected in most participants. There were no significant differences in alpha diversity (within sample) at baseline between groups. However, at the 12-week follow-up, the responder urobiome became significantly richer, with a larger number of genera (p = 0.027) and was significantly more diverse than the nonresponders.ConclusionsLongitudinal urobiome changes are associated with symptom improvement in adult women being treated with mirabegron for UUI. The mechanism for symptoms improvement may relate to the detected changes in the urobiome and warrants further study.

Feasibility, Safety and Efficacy of Fractional Micro-Ablative CO2 Vaginal (FxCO2) Laser Treatment and Platelet-Rich Plasma (PRP) in Women with Urge Urinary Incontinence

Background: Urge urinary incontinence (UUI) is the involuntary loss of urine associated with urgency, frequency, and nocturia. Current management involves behavioural therapies, which can be time-consuming and costly to the patient, and medications, which can have side effects. Fractional micro-ablative CO2 laser (FxCO2) and platelet-rich plasma (PRP) are two novel approaches that may offer symptomatic relief for women with UUI. Objectives: To evaluate the feasibility, safety, and efficacy of FxCO2 vaginal laser treatment and PRP in women with refractory UUI with urinary function and sexual function as secondary outcome measures. Study Design: This was a single-centre prospective cohort study. Participants with UUI underwent three treatments of transvaginal FxCO2 laser and PRP, administered at 4–6-week intervals. Outcomes were assessed with the Australian Pelvic Floor Questionnaire (APFQ) at baseline (T1), 3-6 months (T2), and ≥12 months follow-up (T3). The 12-month follow up data were obtained by face-to-face visit or follow up telephone call. The primary outcome was change in UUI symptoms. Secondary outcomes were related to overall bladder function and sexual function. Outcomes were assessed using Wilcoxon signed-rank test. Results: In this study, 121 participants underwent treatment with FxCO2 laser and PRP for UUI. There was a significant reduction in the average severity of all self-reported measures of primary and secondary outcomes from T1 to T2 (p<0.02). Improvements in all bladder function outcomes remained statistically at T3 (p<0.04). There were no adverse events in this cohort. Conclusion: This study suggests that FxCO2 laser with PRP appears to be a safe, feasible, and effective treatment for UUI, bladder function, and sexual function. FxCO2 laser and PRP may have a role as an alternative therapy for severe and refractory UUI.

Designing Rigorous Methods in Integrative Research: Comparing Mindfulness-Based Stress Reduction with the Health Enhancement Program in the Treatment of Urge Urinary Incontinence in Older Adult Women

Older adult women are marginalized in scientific research. Prior research has been done studying the treatment of urinary urge incontinence through mindfulness-based stress reduction. The highest prevalence of urinary urge incontinence is found in older adult women, yet this is the first study to treat older adult women who have urge urinary incontinence with mindfulness-based stress reduction. The methods of a rigorous pilot feasibility and randomized controlled trial are described from study design through completion. Preparations, procedures, and execution of the study including measures, data management, and statistical analyses are delineated. Considerations necessary due to the specific population are explained.  Authors discuss significant characteristics, results, and successes and difficulties embedded in the methods used.

EDITORIAL COMMENT

Neural modulation has progressed from a near dream to a robust mode of treatment for a variety of conditions including lower urinary tract disorders in a short few years. The concept of access to the peripheral branches of the sacral and pelvic nerves has gone from very invasive and morbid procedures such as dorsal rhizotomy to percutaneous access to S3 foramen and now insertion of a nickel size device. In this article the authors report the results of safety and feasibility (not efficacy) of implantation the eCoin - a nickel-sized, primary battery powered, neuromodulation device for the treatment of urgency urinary incontinence (UUI) in 46 subjects (45 women) after 12 months of treatment.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study

To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Sacral electroacupuncture as a treatment for urge urinary incontinence: a prospective case series.

To examine the impact of electroacupuncture (EA) at the 'four sacral points' on urge urinary incontinence (UUI). Twenty-five patients diagnosed with UUI or urgency-predominant mixed urinary incontinence (MUI) were treated by EA at the 'four sacral points'. EA was performed in the sacrococcygeal region using disposable sterile 0.40-mm-diameter acupuncture needles that were either 100 or 125 mm in length. Treatments were delivered once every other day. Before and after treatment, a questionnaire measuring symptom severity and quality of life associated with UUI was administered. The median total score (interquartile range) from the severity of symptoms and the quality of life questionnaire (Q-score) of the participants was significantly reduced from 12 (7.5, 15) before treatment to 3 (0, 6) after 6 (6, 12) EA treatments. The Q-score of urgency-predominant MUI and UUI was 8 (5, 14.5) and 12.5 (11, 15), respectively, before treatment; after treatment these were reduced to 2 (0, 7.5) and 4.5 (2, 6), respectively. There was no statistically significant difference in the Q-score between urgency-predominant MUI and UUI before and after treatment. Upon treatment completion, seven patients (28%) were 'cured' (improvement rate 100%). Treatments were considered 'markedly effective' (improvement rate 75% to <100%) in four patients (16%), 'effective' (improvement rate 50% to <75%) in eight patients (32%), 'minimally effective' (improvement rate 25% to <50%) in three patients (12%), and 'ineffective' (improvement rate <25%) in three patients (12%). The overall success rate (comprising 'cured', 'markedly effective' and 'effective' categories) was 76%, and no adverse effects associated with acupuncture treatment were reported. EA at the 'four sacral points' was associated with statistically significant improvements in UUI.

Does symptom severity predict response to low-dose onabotulinumtoxinA for the treatment of urgency urinary incontinence?

ObjectiveIntradetrusor onabotulinumtoxinA is a third-line treatment for urgency urinary incontinence (UUI) which is customarily reserved for severe disease. We sought to determine if symptom severity predicts the proportional response to onabotulinumtoxinA and whether low-dose injection may be an appropriate treatment for mild-moderate symptoms. Study DesignThis prospective cohort study compared patients with urgency urinary incontinence who were recruited from the Urogynecology Clinic with mild-moderate (2–9 episodes/3-day diary) and severe UUI (>9 episodes/3-day diary) symptoms. Twenty-eight subjects were treated (11 mild-moderate, 17 severe) with 50 units of intradetrusor onabotulinumtoxinA. Voiding diaries and validated questionnaires (UDI-6 and IIQ-7) were collected at baseline and one, six, and twelve months post-treatment. The primary outcome was the difference in percent reduction in UUI episodes per 3-day diary at one month. Secondary outcomes included differences in absolute reduction of UUI events, treatment success rate (defined as greater than 50% reduction in UUI episodes), changes in UDI-6 and IIQ-7 questionnaire scores, and rates of urinary retention, self-catheterization, and urinary tract infection. Normally distributed data are presented as means with standard deviations (SD) and groups were compared using the two sample t-test. Data that were not normally distributed are presented as medians with the interquartile range (IQR) and were compared using the Wilcoxon rank sum test. ResultsThe mild-moderate group showed median improvement; 100% (IQR: 100%, 100%) and severe group; 81% (IQR: 35%, 100%), p < 0.019. Both had significant improvement in UUI episodes; the mild-moderate group decreased by four and the severe group by 15. No differences were noted in percent reduction between groups. There was no association between baseline severity and percent reduction in UUI episodes (rs = 0.127, p = 0.544); however, absolute reduction was highly correlated (rs = −0.821, p < 0.001). Treatment success was 90% in mild-moderate and 73% in the severe group (p = 0.615). Complications included urinary tract infections (25%) and intermittent catheterization (3.6%). ConclusionsPatients with both mild-moderate and severe symptoms showed a statistically significant improvement in UUI events from baseline to one month, but no difference between the groups in proportional improvement or treatment success.

Mind-body (hypnotherapy) treatment of women with urgency urinary incontinence: changes in brain attentional networks

Prior study of patients with urgency urinary incontinence by functional magnetic resonance imaging showed altered function in areas of the brain associated with interoception and salience and with attention. Our randomized controlled trial of hypnotherapy for urgency urinary incontinence demonstrated marked improvement in urgency urinary incontinence symptoms at 2 months. A subsample of these women with urgency urinary incontinence underwent functional magnetic resonance imaging before and after treatment. This study aimed to determine if hypnotherapy treatment of urgency urinary incontinence compared with pharmacotherapy was associated with altered brain activation or resting connectivity on functional magnetic resonance imaging. A subsample of women participating in a randomized controlled trial comparing hypnotherapy vs pharmacotherapy for treatment of urgency urinary incontinence was evaluated with functional magnetic resonance imaging. Scans were obtained pretreatment and 8 to 12 weeks after treatment initiation. Brain activation during bladder filling and resting functional connectivity with an empty and partially filled bladder were assessed. Brain regions of interest were derived from those previously showing differences between healthy controls and participants with untreated urgency urinary incontinence in our prior work and included regions in the interoceptive and salience, ventral attentional, and dorsal attentional networks. After treatment, participants in both groups demonstrated marked improvement in incontinence episodes (P<.001). Bladder-filling task functional magnetic resonance imaging data from the combined groups (n=64, 30 hypnotherapy, 34 pharmacotherapy) demonstrated decreased activation of the left temporoparietal junction, a component of the ventral attentional network (P<.01) compared with baseline. Resting functional connectivity differed only with the bladder partially filled (n=54). Compared with pharmacotherapy, hypnotherapy participants manifested increased functional connectivity between the anterior cingulate cortex and the left dorsolateral prefrontal cortex, a component of the dorsal attentional network (P<.001). Successful treatment of urgency urinary incontinence with both pharmacotherapy and hypnotherapy was associated with decreased activation of the ventral (bottom-up) attentional network during bladder filling. This may be attributable to decreased afferent stimuli arising from the bladder in the pharmacotherapy group. In contrast, decreased ventral attentional network activation associated with hypnotherapy may be mediated by the counterbalancing effects of the dorsal (top-down) attentional network.

Transcutaneous tibial nerve stimulation to treat urgency urinary incontinence in older women: 12-month follow-up of a randomized controlled trial

Urgency urinary incontinence (UUI) is highly prevalent in elderly individuals and has a great impact on quality of life. Transcutaneous tibial nerve stimulation (TTNS) can be an effective treatment option for UUI in older women. This is a single-center randomized clinical trial with a 12-month follow-up involving 106 women > 60years of age. Kegel exercises and bladder retraining were performed alone or in combination with TTNS, which consisted of using a transcutaneous electrical nerve stimulator for 30min once a week for 12weeks with the following settings: continuous mode, 10Hz, 200ms, and 10 to 50mA (according to hallux mobilization). Responders to therapy who experienced failure during follow-up were invited for a 3-week protocol with the same parameters as those used for the initial therapy. Patients were evaluated at baseline, 4weeks after the 12-week protocol, and every 3months for 12months, through subjective satisfaction questionnaires, a 3-day bladder diary and the International Consultation on Incontinence Questionnaire-Short Form. King's Health Questionnaire was applied pretreatment and 4weeks after the last session of the 12-week protocol. A total of 101 women completed the initial 12-week protocol. TTNS patients reported 66.7% subjective global satisfaction vs. 32.0% in the control group (p< 0.001). The TTNS group showed statistically significant improvement in quality of life (QoL) and UUI parameters compared with the control group. Forty-eight patients were satisfied after the 12-week protocol and completed the 12-month follow-up (32 in the TTNS group and 16 in the control group). A total of 80.5% of responders to TTNS were still satisfied at the end of the 12-month follow-up vs. 30.8% in the control group (p= 0.009). TTNS is effective at the 12-month follow-up for the treatment of UUI in elderly women.

Cost-Effectiveness Analysis and Budget Impact: Antimuscarinics and Mirabegron for the Treatment of Patients With Urge Urinary Incontinence: The Brazilian Public Health System Perspective

ObjectivesThe Brazilian public health system does not cover pharmacotherapy for urge urinary incontinence (UUI). The aim of this study was to estimate the cost-effectiveness and budget impact of providing tolterodine, solifenacin, oxybutynin (OXY), darifenacin, and mirabegron for the treatment of UUI in Brazilian public health system. MethodsA cost-effectiveness analysis with budget impact was performed. Six scenarios were assessed: in one scenario, all 5 therapeutic alternatives approved for coverage, and in the remaining 5 scenarios, only 1 alternative is approved for adoption for all patients. Clinical data were derived from a rapid systematic review conducted in several databases. One-way sensitivity analysis was also performed. The time horizon was 12 months. ResultsThe cost-effectiveness analysis showed that patients treated with OXY had the lowest incremental cost-effectiveness ratio (ICER) per outcomes assessed (change in urinary incontinence episodes (UIE): R$1180.08; change in urge incontinence episodes: R$757.85 and change in micturition frequency: R$907.75), corresponding to a budget impact of R$17.9 billion over 5 years. The change in effectiveness measures was the parameter that most influenced the results of the ICER per patient-year. ConclusionThe results of the study have shown that OXY and solifenacin had the lowest ICER per patient-year and the lowest budget impact when compared with other drugs.