Treatment Of Urge Urinary Incontinence Research Articles

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.

Estimulación percutánea del nervio tibial en la incontinencia urinaria de urgencia: estudio prospectivo

ObjectiveTo assess the efficacy of percutaneous tibial nerve stimulation and its effectiveness over time in urge urinary incontinence. Materials and methodsWe performed a longitudinal, observational, prospective study without a control group that included patients diagnosed with urge urinary incontinence who met the inclusion/exclusion criteria. Patients were treated with 12 sessions of percutaneous tibial nerve stimulation by electroacupuncture. Baseline and post-treatment data were collected from medical records. Patients were assessed by a telephone interview after the treatment. The variables studied were sociodemographic variables, time until interview, the Sandvick and ICIQ-SF questionnaires, daytime urinary frequency, night-time urinary frequency, use of absorbent material and drug treatment. A descriptive analysis of the variables was performed and patient outcomes were analysed with generalised linear mixed models by SPSS v. 25 statistics software. ResultsA total of 32 women were included (mean age 58.69±8.96). All variables significantly improved after treatment: Sandvick by 4.38 points (95% CI: 2.68-6.08, P<.001), ICIQ-SF by 8.55 points (95% CI: 5.89-11.22, P<.001), daytime urinary frequency by 2.10 points (95% CI: 1.04-3.16, P<.001) and night-time urinary frequency by 1.31 points (95%CI: 0.58-2.04, P<.001). However, 16.34±9.72 months after treatment, these improvements diminished but without reaching baseline levels. ConclusionsPercutaneous tibial nerve stimulation by electroacupuncture is effective for the treatment of urge urinary incontinence. Although its effect diminishes over time, the improvement over the baseline situation is maintained during the follow-up period.

Randomized controlled trial for the efficacy of electroacupuncture in the treatment of urge urinary incontinence: A clinical study protocol.

Background:Despite that the urge urinary incontinence (UUI) is a nonfatal disease, it can lead to anxiety, embarrassment and depression to the patient. UUI is a common public health problem that can significantly affect the quality of life of the patient. Several conservative treatments have been recommended for the treatment of UUI; however, their efficiency remains unclear, leaving the disease without a real effective treatment. The clinical application of acupuncture to treat UUI is currently considered an effective approach despite the limited evidence that support its efficiency. The aim of this study is to assess the efficacy and safety of electroacupuncture therapy in the treatment of UUI.Methods and analysis:A randomized, parallel, controlled study will be performed. Patients with UUI treated with electroacupuncture group (EA) will compare with the sham-treated sham EA (SA) patients. A total of 100 participants with UUI will be randomly allocated to either the EA or the SA group with a 1:1 ratio. The treatment of UUI patients will performed 3 times per week, for 8 weeks in 30-minute sessions. At the end of the treatment the patients will be followed-up until week 32. The primary outcomes include scores of incontinence questionnaire-short form, the average 24-hour urgency incontinence episodes, and the average 24-hour urge episodes responses from baseline until the 4th, 8th , 24th, and 32nd week. The secondary outcomes included the average 24-hour urine volume and the average 24-hour micturition frequency responses from baseline until the 8th and 32nd week, as well as the change in incontinence quality of life scores from baseline at the 8th and 32nd week. In addition, the degree of satisfaction of the participants undergoing acupuncture treatment will be measured at the 4th and 8th week. The participants’ clinical acupuncture expectations were evaluated at baseline, and the questionnaire for urinary incontinence diagnosis was used to identify stress incontinence, mixed urinary incontinence, and urge incontinence at baseline.Discussion:This is a randomized, controlled, observer-blinded trial of electroacupuncture treatment for UUI. The results of this trial will provide more evidence on whether electroacupuncture is efficacious for treating UUI.

Clam augmentation enterocystoplasty as management of urge urinary incontinence and reduced bladder capacity

Objectives: Third line treatment of urge urinary incontinence (UUI) and/or reduced bladder capacity is bladder augmentation. The aim of this study was to investigate whether clam enterocystoplasty (CECP) was an efficient treatment for patients who were refractory to conservative treatments of UUI and small functional bladder capacity and secondly if there was a difference in outcome in patients with neurogenic and non-neurogenic bladders.Methods: We evaluated 118 patients retrospectively treated in the period 2006–2018 at a single university hospital. Data were collected retrospectively. Patient groups were compared with Wilcoxon signed-rank test and Fisher’s exact test.Results: Overall, 76% became continent with 92% using clean intermittent self-catherization (CISC) of patients with neurogenic bladder, 82% became continent and 100% were using CISC, whereas of patients with non-neurogenic bladder 64% became continence and 77% were using CISC. The median overall improvement of capacity was 296.5 mL (IQR: 142–440), 310 mL (186–467) in the neurogenic group and 214 mL (IQR: 126.8–361.5) in non-neurogenic (p = 0.01).Conclusion: CECP is an efficient treatment in UUI and reduced bladder capacity. Difference in outcome was seen with neurogenic patients having a bigger functional capacity and a higher rate of continence compared to the non-neurogenic.

2578 Promising Effect of Platelet-Rich Plasma And CO2 Laser in Urinary Incontinance

Study Objective To evaluate the safety, feasibility and efficacy of trans-vaginal fractional micro-ablative CO2 laser therapy in combination with platelet rich plasma (PRP) for the treatment of urinary urge incontinence in women. Design Prospective observational cohort study. Setting Single private gynecology practice in Adelaide, Australia between 2013 and 2018. Patients or Participants 128 women, of whom 62 women were diagnosed with stress urinary incontinence and 66 women with urinary urge incontinence. Interventions PRP and CO2 laser were used for 3 treatments. There was 4-6 weeks interval between each treatment. Measurements and Main Results Patient outcomes were reviewed subjectively and objectively at baseline, 3 months and 12 months. The Australian Pelvic Floor Questionnaire (APFQ) and physical examination were employed to assess outcomes. • Patients with moderate to severe stress incontinence improved 63% at 12 months (p=0.001) • Patients with moderate to severe urge incontinence improved 55% at 12 months (p=0.003) Conclusion PRP and vaginal laser appear to be promising alternative treatments for urinary incontinence with potential reduction in cost to both the patient and national health systems without any complications or side-effects. However, the true efficacy of these modalities need to be examined in an RCT setting.

Mindfulness-Based Stress Reduction Versus a Health Enhancement Program in the Treatment of Urge Urinary Incontinence in Older Adult Women: A Randomized Controlled Feasibility Study.

Older adult women with high incidence of UUI. MBSR treatment conditions or HEP comparison conditions. Research and intervention feasibility determinants. The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial. [ Research in Gerontological Nursing, 12(6), 285-297.].

73: Impact of refractory urgency urinary incontinence treatment on bowel and sexual function

73: Impact of refractory urgency urinary incontinence treatment on bowel and sexual function

Initial clinical experience with selective bladder denervation for refractory overactive bladder.

AimsTo report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB).MethodsFemales with refractory OAB underwent SBD of the bladder sub‐trigone region. Patients were treated using a 10‐s voltage‐controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60‐s temperature‐controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed.ResultsAmong 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (−2.5 vs −0.9; P < 0.01), urinary incontinence (−2.6 vs −0.8; P < 0.001), and total urgency and frequency score (−13 vs −7; P = 0.02); and improvements in symptom bother (−33 vs −18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device‐ or procedure‐related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%).ConclusionsThis study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60‐s RF algorithm using deeper ablations of the sub‐trigonal tissues was more effective and comparably safe to a 10‐s RF algorithm using more superficial ablations.

Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence

BackgroundWe conducted a clinical feasibility trial to evaluate the safety and efficacy of a fully-implanted, primary battery-powered, nickel-sized and shaped neuromodulation device called the eCoinTM (Valencia Technologies Corp., Valencia, CA, USA) for tibial nerve stimulation to treat refractory urgency urinary incontinence. MethodsThis was a prospective, single-arm, open-label study including 46 participants with refractory UUI, conducted at multiple sites in the US and New Zealand. The eCoinTM was implanted 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 and 6 months post-activation, were compared to baseline. ResultsMean age was 63.4 ± 11.5 years and 45 (98%) participants were female. Episodes of urgency urinary incontinence were reduced by a median 71% after 3 months of treatment (4.2 versus 1.7 daily episodes at 3 months; P=.001). A ≥50% reduction in reported episodes of urgency urinary incontinence was observed in 32/46 participants (69.6%) at 3 months with more than 20% of participants dry at 3 and at 6 months. Incontinence quality of life (I-QOL) scores improved by an average of 25.9 points, and 33/46 patients (72%) indicated improvement in symptoms. A single serious adverse event, secondary to wound care, resolved with intravenous antibiotics. ConclusionsThe implantable neuromodulation device was a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or resolution of symptoms and no significant safety concerns.

What Is the True Catheterization Rate After Intravesical OnabotulinumtoxinA Injection?

(Abstracted from Int Urogynecol J 2018;29:1005–1009) Intravesical onabotulinumtoxinA (Botox) is widely used for the treatment of urinary urge incontinence and overactive bladder (OAB). One of the most common complications of intravesical onabotulinumtoxinA injection is incomplete bladder emptying requiring clean intermittent catheterization (CIC).

CESA/VASA: Tratamento da Incontinência Urinária de Urgência Idiopática por Via Laparoscópica

CESA/VASA é uma nova técnica que tem como objetivo principal o tratamento curativo da incontinência urinária de urgência, patologia conhecida como bexiga hiperativa idiopática. A técnica consiste numa abordagem cirúrgica abdominal (aberta ou laparoscópica) com a aplicação de uma fita (CESA/VASA) que se fixa ao colo uterino ou à cúpula vaginal, sendo inserida no lugar onde existiam os ligamentos útero-sagrados (ligamentoplastia), e fixada ao osso sacro. Isto faz com que, graças à tensão e suporte desenvolvidos pela fita aplicada, a bexiga volte à sua posição anatómica habitual. Este caso retrata uma doente, 72 anos, com queixas de incontinência urinária mista. Efetuou vários tipos de medicação (anti-muscarínicos e mirabegron) sem grandes melhorias. Realizou estudo urodinâmico que confirma a presença de incontinência urinária de esforço e bexiga hiperativa.Foi submetida a colocação de fita CESA por via laparoscópica + sling sub-uretral (TOT) por via transvaginal. Cirurgia e pós-operatório sem intercorrências. Após quatro semanas da intervenção, a doente foi reavaliada afirmando estar assintomática.

Sacral neuromodulation for treatment of overactive bladder: a review

Sacral neuromodulation (SNM) therapy is an established third line therapeutic option for the treatment of urgency urinary incontinence, urgency-frequency and chronic non-obstructive urinary retention. The continuous stimulation of the sacral root S3 with an electrode connected to an implanted pulse generator (IPG) may influence detrusor and sphincter activity and improve lower urinary tract symptoms. The mechanism of action is not completely understood and seems to be based on the modulation of spinal cord reflexes and brain centers involved in lower urinary tract function. It is implanted with a minimally invasive technique that can be performed under local anesthesia and includes a test phase that precedes the definitive implantation of the pulse generator. When compared to the standard pharmacological therapy, neuromodulation promoted better results both in the partial improvement of overactive bladder (OAB) symptoms and total continence. Moreover, sexual function, quality of life and depressive symptoms may also improve in patients with OAB that undergo SNM. However, SNM is associated with significant rates of adverse events and need for surgical revisions, requiring continuous medical attention.

Barriers to Exercise Among Women With Urgency Urinary Incontinence: Patient and Provider Perspectives

The aim of this study was to describe important barriers to exercise in older women with urgency urinary incontinence (UUI) from the patient and provider perspectives. Six focus groups (2 in active women, 2 in sedentary women, and 2 in providers) were conducted with 36 women with UUI and 18 providers. Focus group discussions were transcribed verbatim. All transcripts were coded and analyzed by 2 independent reviewers. Investigators identified emergent themes and concepts using a modified biopsychosocial conceptual model. A wide range of physical, psychological, social, and environmental factors were perceived to influence exercise. Although women with UUI identified pain as a strong barrier to exercise, providers did not. Both women with UUI and providers identified shame associated with incontinence as a significant barrier, and, conversely, satisfaction with UUI treatment was noted as an enabler for exercising. Women and providers had incongruent views on the need for supervision during exercise; women viewed supervision as a barrier to exercise, whereas providers viewed lack of supervision as a barrier to exercise. Opportunity for socialization was noted as a major enabler of exercise by all groups and suggests that exercise programs that promote interactions with peers may increase exercise participation. The importance of financial incentive and reimbursement was congruent between women and their providers. Women with UUI have unique perspectives on barriers to exercise. Understanding women's perspective can aid clinicians and researchers in improving exercise counseling and in creating exercise programs for women with UUI.

Association of Pharmacologic Treatment of Urgency Urinary Incontinence With Sleep Quality and Daytime Sleepiness

(Abstracted from Obstet Gynecol 2018;131:204–211) Both incontinence and sleep disturbance are common and bothersome conditions in middle-aged and older women. Any treatment that improves both conditions may provide clinical value.

Sleep Quality and Daytime Sleepiness Among Women With Urgency Predominant Urinary Incontinence.

The objective of this study was to examine the strength and direction of the association between urinary symptoms and both poor quality sleep and daytime sleepiness among women with urgency urinary incontinence. A planned secondary analysis of baseline characteristics of participants in a multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in ambulatory women self-diagnosed by the 3 Incontinence Questions was performed. Urinary symptoms were assessed by 3-day voiding diaries. Quality of sleep was assessed using the Pittsburgh Sleep Quality Index (PSQI) and daytime sleepiness using the Epworth Sleepiness Scale. Of the 640 participants, mean (SD) age was 56 (±14) years and 68% were white. Participants reported an average of 3.9 (±3.0) urgency incontinence episodes per day and 1.3 (±1.3) episodes of nocturia per night. At baseline, 57% had poor sleep quality (PSQI score, >5) and 17% reported daytime sleepiness (Epworth Sleepiness Scale score, >10). Most women (69%) did not use sleeping medication during the prior month, whereas 13% reported use of sleeping medication 3 or more times per week. An increase in total daily incontinence episodes, total daily urgency incontinence episodes, total daily micturitions, and moderate to severe urge sensations were all associated with higher self-report of poor sleep quality according to the PSQI (all P ≤ 0.01). Higher scores on the Bother Scale and the Health-Related Quality of Life for overactive bladder on the Overactive Bladder Questionnaire were similarly associated with higher rates of poor sleep quality (both P ≤ 0.01). In subgroup analysis of those who took sleeping medications less than twice a week, there was still a significant relationship between incontinence measures and quality of sleep as measured by the PSQI. In multivariable analyses, greater frequency of nighttime urgency incontinence was associated with poor sleep quality (P = 0.03). Among ambulatory women with urgency urinary incontinence, poor sleep quality is common and greater frequency of incontinence is associated with a greater degree of sleep dysfunction. Women seeking urgency urinary incontinence treatment should be queried about their sleeping habits so that they can be offered appropriate interventions.

Association of Pharmacologic Treatment of Urgency Urinary Incontinence With Sleep Quality and Daytime Sleepiness.

To evaluate the association between pharmacologic therapy for urgency urinary incontinence (UUI) and sleep quality. We conducted a planned secondary data analysis of sleep outcomes in a previously conducted multicenter, double-blind, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence among community-dwelling women self-diagnosed using the 3-Incontinence Questions questionnaire. Participants (N=645) were assigned randomly to 4-8 mg antimuscarinic therapy daily or placebo. At baseline and 12 weeks, participants completed a validated voiding diary to evaluate incontinence and voiding symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep quality, and the Epworth Sleepiness Scale to evaluate daytime sleepiness. Mean (SD) age was 56 (±14) years, 68% were white, and 57% had poor sleep quality (Pittsburgh Sleep Quality Index score greater than 5). Mean frequency of any urinary incontinence and UUI was 4.6 and 3.9 episodes/d, respectively. After 12 weeks, women randomized to the antimuscarinic group reported greater decrease compared with the placebo group in UUI frequency (0.9 episodes/d; P<.001) and diurnal and nocturnal voiding frequency (P<.05). As compared with the placebo group, women in the antimuscarinic group also reported greater improvement in sleep quality (total Pittsburgh Sleep Quality Index score 0.48; P=.02) with greater improvement in sleep duration and sleep efficiency subscales (P<.05). The intervention did not affect daytime sleepiness. Pharmacologic treatment of UUI is associated with decreased incontinence frequency and nocturia and improvement in overall sleep quality, sleep duration, and sleep efficiency. ClinicalTrials.gov, NCT00862745.

Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications

Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation. The objective of the study was to compare treatment efficacy and adverse events in women <65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation. This study was a planned secondary analysis of a multicenter, randomized trial that enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments. The primary outcome was a change in mean daily urgency urinary incontinence episodes on a bladder diary over 6 months. Secondary outcomes included ≥75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events. Both age groups experienced improvement in mean urgency urinary incontinence episodes per day following each treatment. There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P= .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P= .227). Among those treated with onabotulinumtoxinA, women <65 years had 3.3-fold greater odds of ≥75% resolution than women ≥65 years (95% confidence interval, 1.56 -7.02). Women <65 years had a greater reduction in Overactive Bladder Questionnaire Short Form symptom bother scores compared with women ≥65 years by 7.49 points (95% confidence interval, -3.23 to -11.74), regardless of treatment group. There was no difference between quality of life improvement by age. Women ≥65 years had more urinary tract infections following onabotulinumtoxinA and sacral neuromodulation (odds ratio, 1.9, 95% confidence interval, 1.2-3.3). There was no evidence of age differences in sacral neuromodulation revision/removal or catheterization following onabotulinumtoxinA treatment. Younger women experienced greater absolute continence, symptom improvement, and fewer urinary tract infections; both older and younger women had beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events, and improved quality of life.

MP63-05 NOVEL URODYNAMIC FINDINGS IN FEMALE PATIENTS WITH URGENCY URINARY INCONTINENCE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Incontinence: Evaluation (Urodynamic Testing)1 Apr 2017MP63-05 NOVEL URODYNAMIC FINDINGS IN FEMALE PATIENTS WITH URGENCY URINARY INCONTINENCE Liang Dong, Jiayi Li, Jianwei Lv, Jing Leng, Wei Xue, and Yiran Huang Liang DongLiang Dong More articles by this author , Jiayi LiJiayi Li More articles by this author , Jianwei LvJianwei Lv More articles by this author , Jing LengJing Leng More articles by this author , Wei XueWei Xue More articles by this author , and Yiran HuangYiran Huang More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1957AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The purpose of this study is to analyze the urodynamic features of female patients with urge urinary incontinence (UUI). The study tries to classify female UUI types according to their urodynamic features, so as to improve the level of personalized clinical diagnosis and treatment for female UUI. METHODS A retrospective urodynamic study was performed among 102 female patients diagnosed with UUI who presented to our center between June 2015 and June 2016. All recruited patients were required to complete several examinations besides history taking, including urine analysis, ultrasound of KUB, and PVR. After that, 44 patients with urinary tract infection (UTI), cancer, stone disease, neurogenic bladder or different kinds of cystitis were excluded. The remained 58 patients were evaluated by UDS, collecting data of bladder compliance, detrusor involuntary contraction and urethra response in storage phase. The study focused on whether there were detrusor overactivity and coexsisted urethral pressures changes in storage phase. RESULTS The mean age of the studied patients was 63 years (SD 10.1). All patients had normal bladder compliance in storage phase. No obvious abnormal in voiding phase were found except for 2 cases failing to induce automatic micturition. According to whether there was involuntary detrusor contraction or not in storage phase, patients were divided into two types. No involuntary detrusor contractions were demonstrated in 22 patients (37.9%), though having a strong micturition desire during UDS. Involuntary detrusor contractions were demonstrated in 36 patients(62.1%)which could be further divided into two types. Among 36 patients, simultaneous decrease of urethra pressure was demonstrated in 19 patients(32.8%)while 17 others did not(29.3%). CONCLUSIONS UUI often pose a negative impact on the quality of life in female patients. UDS is an excellent choice to show the pathophysiological changes of lower urinary tract in female patients with UUI. This study shows that UUI in female patients could be classified into three different types based on UDS. Type I: involuntary detrusor contractions with simultaneous decrease of urethra pressure; type II: involuntary detrusor contractions without simultaneous decrease of urethra pressure; type III: no involuntary detrusor contractions, neither simultaneous decrease of urethra pressure. These three different types of UUI shows there could be a potential difference with the underlying mechanisms, which may benefit the development of personalized treatment for UUI. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e837 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Liang Dong More articles by this author Jiayi Li More articles by this author Jianwei Lv More articles by this author Jing Leng More articles by this author Wei Xue More articles by this author Yiran Huang More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Urge 1 Study – A randomized cross-over clinical trial to compare medical treatment of urgency urinary incontinence with surgical treatment

Urge 1 Study – A randomized cross-over clinical trial to compare medical treatment of urgency urinary incontinence with surgical treatment

Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence

We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. We describe the development and design challenges of a study comparing the efficacy of hypnotherapy and conventional pharmacotherapy in the treatment of UUI. The study randomizes women to either of these treatments, and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a noninferiority test (alpha = 0.025, beta = 0.20), after considering dropout subjects and subjects lost to follow-up, indicated that approximately 150 woman would be required to test the hypothesis that hypnotherapy is not inferior to pharmacotherapy within a 5% noninferiority margin. The study will also evaluate fMRI changes in a subset of participants before and after therapy. Challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, and confronting the reality that trials are time-consuming for participants who have to make appropriate accommodations in their schedule. Study enrollment began in March 2013 and is ongoing. We describe the design of a randomized controlled trial comparing mind-body therapy and pharmacotherapy in the treatment of UUI and the challenges encountered in its implementation.