National Trends in Neuromodulation for Urinary Incontinence Among Insured Adult Women and Men, 2004-2013: The Urologic Diseases in America Project.

OBJECTIVE: To examine US trends in neuromodulation for urinary incontinence (UI) treatment from 2004 to 2013. METHODS: This study utilized 2 data sources: the Optum© de-identified Clinformatics® Data Mart Database for privately insured adults aged 18-64 years with a UI diagnosis (N≈40,000 women and men annually) and the Medicare 5% Sample for beneficiaries aged ≥65 years with a UI diagnosis (N≈65,000 women and men annually). We created annual cross-sectional cohorts and assessed prevalence of UI-related neuromodulation procedures among men and women separately from 2004 to 2013. Analyses were conducted overall and stratified by age, race/ethnicity, and geographic region. RESULTS: Nearly all neuromodulation procedures occurred in outpatient settings. Sacral neuromodulation (SNM) procedures for UI in both women and men grew steadily from 2004 to 2013, with more procedures performed in women than men. Among women with UI, SNM prevalence grew from 0.1%-0.2% in 2004 to 0.5%-0.6% in 2013. Posterior tibial nerve stimulation (PTNS) experienced growth from 2011 to 2013. Chemodenervation of the bladder with onabotulinumtoxinA (BTX) combined with other injectable procedures (including urethral bulking) remained stable over time. CONCLUSIONS: From 2004 to 2013, SNM procedures remained relatively uncommon but increased consistently. PTNS experienced growth starting in 2011 when PTNS-specific insurance claims became available. BTX trends remain unclear; future studies should assess it separately from other injectable procedures. Neuromodulation has a growing role in UI treatment, and ongoing trends will be important to examine.

ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial.

BACKGROUND: Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents' dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences. METHODS: This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. DISCUSSION: TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03248362. Registered on 14 August 2017. ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.

Cost-effectiveness analysis of solifenacin versus oxybutynin immediate-release in the treatment of patients with overactive bladder in the United Kingdom.

OBJECTIVE: To carry out a cost-utility analysis comparing initial treatment with solifenacin 5 mg/day vs oxybutynin immediate-release (IR) 15 mg/day for the treatment of patients with overactive bladder (OAB) from the perspective of the U.K. National Health Service (NHS). METHODS: A Markov model with six health states was developed to follow a cohort of OAB patients treated with either solifenacin or oxybutynin during a 1-year period. Costs and utilities were accumulated as patients transited through the health states in the model and a drop-out state. Some of the solifenacin patients were titrated from 5 mg to 10 mg/day at 8 weeks. A proportion of drop-out patients were assumed to continue treatment with tolterodine ER. Utility values were obtained from a Swedish study and pad use was based on a multinational clinical trial. Adherence rates for individual treatments were derived from a U.K. database study. For pad use and utility values, the drop-out state was split between those patients who were no longer receiving treatment and those on second-line therapy. Patients on second-line therapy who drop-out were referred for a specialist visit. Results were expressed in terms of incremental cost-utility ratios. RESULTS: Total annual costs for solifenacin and oxybutynin were £504.30 and £364.19, respectively. First-line drug use represents 49% and 4% of costs and pad use represent 23% and 40% of costs for solifenacin and oxybutynin, respectively. Differences between cumulative utilities were small but were greater for solifenacin (0.7020 vs. 0.6907). The baseline incremental cost-effectiveness ratio was £12,309/QALY. CONCLUSION: Under the baseline assumptions, solifenacin would appear to be cost-effective with an incremental cost-utility of less than £20,000/QALY. However, small differences in utility between the alternatives and the large number of drop-outs means that the results are sensitive to small adjustments in the values of utilities assigned to the drop-out state.

Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.

OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical prostatectomy or a transurethral resection of the prostate (TURP). BACKGROUND: Urinary incontinence after radical prostate surgery is common immediately after surgery, although the chance of incontinence is less after TURP than following radical prostatectomy. DESIGN: Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial prostatectomy and TURP. SETTING: Men having prostate surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. PARTICIPANTS: Men with urinary incontinence at 6 weeks after prostate surgery were eligible to be randomised if they consented and were able to comply with the intervention. INTERVENTIONS: Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. MAIN OUTCOME MEASURES: The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. RESULTS: Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [£ 181.02 (95% CI £ 107 to £ 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [£ 209 (95% CI £ 147 to £ 271)] and societal costs [£ 420 (95% CI £ 54 to £ 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. CONCLUSIONS: The provision of one-to-one conservative physical therapy for men with urinary incontinence after prostate surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Sacral neuromodulation: cost considerations and clinical benefits.

OBJECTIVES: To demonstrate the efficacy of sacral neuromodulation and compare voiding-related health care utilization costs before and after receiving an implant. METHODS: A retrospective review of patients receiving InterStim therapy (Medtronic Neurological, Minneapolis, Minn) was completed. Health care utilization was determined for the year before and the year after implantation, and included hospital and clinic visits, diagnostic and therapeutic procedures, and prescriptions. Utilization costs were derived from Medicare CPT coding and reimbursement data. Drug costs were derived from the actual pharmacy costs. Efficacy was assessed subjectively by patient-reported questionnaire and objectively by voiding diary, pad usage, and number of catheterizations. RESULTS: Sixty-five patients received InterStim therapy. Outpatient visits for urinary symptoms decreased in the 12 months after implantation with a mean decrease of 2.2 visits (P <0.0001). This resulted in a 73% reduction in average yearly office visit expenses from $994 to $265 per patient. After implant, diagnostic and therapeutic procedures performed decreased by 0.97 (P <0.0001). This translated into a decrease in the cost of therapeutic and diagnostic procedures from $733 to $59 per patient (P <0.0001). Drug costs were significantly decreased (P <0.02) from $693 to $483 per patient. These cost savings represent a 92% reduction in outpatient doctor visits and diagnostic and procedure costs along with and a 30% reduction in drug expenditures. CONCLUSION: After InterStim therapy, voiding-related health care costs are reduced. InterStim therapy is an effective treatment option with high patient satisfaction for medically refractory voiding dysfunction.

Pharmacological management of women with mixed urinary incontinence.

Mixed urinary incontinence (MUI) is a symptomatic diagnosis. It is defined by the International Continence Society as the complaint of involuntary leakage associated with urgency and also with exertion, effort, sneezing and coughing. A search of medical databases revealed that only a small number of limited studies that assess the prevalence, epidemiology and treatment of MUI have been conducted. Most studies have looked separately at either stress urinary incontinence or urgency urinary incontinence. Thus, management of MUI involves a combination of treatments for both stress and urgency incontinence, but should concentrate initially on the most bothersome and/or predominant symptom. Initial management includes an accurate history and examination, which is supplemented by a bladder diary and quality-of-life questionnaire. Once a preliminary diagnosis is established, first-line therapy includes patient education and lifestyle interventions, such as weight loss. This is supplemented by pelvic floor muscle training and bladder training, which help with both components of MUI. Oral pharmacotherapy often acts synergistically with the previous treatments; however, only very few randomised, placebo-controlled trials have looked at the effects of pharmacotherapy on MUI. The two main classes of drugs are the antimuscarinics, which are effective in urgency incontinence, and the serotonin-norepinephrine re-uptake inhibitors, which are effective in stress incontinence. Combination of these two drug classes is a feasible option but has not been tested in any trials to date. Should these treatments fail, then patients should be referred for cystometry to confirm the diagnosis. Treatment options available following urodynamics include invasive minor and major surgical procedures, which either treat the stress or urgency component of MUI but not both. Surgical procedures carry the risk of infection, haemorrhage and failure.

Biofeedback therapy in pediatric urology.

Biofeedback is one of the unique treatment options available in the management of voiding dysfunction in children. The focus of biofeedback in pediatric urology is on pelvic floor muscle retraining. Biofeedback uses monitoring devices and strategically placed electrodes to obtain and relay to the child visual and/or auditory cues on bladder emptying activity. The visual and auditory cues help train the child to sense, interpret, and respond to the body's messages related to voiding activity. The overall goal is to improve the child's ability to store urine and empty the bladder more effectively.

The role of neuromodulation in the management of urinary urge incontinence.

OBJECTIVE: To examine the benefit-risk profile of neuromodulation in treating refractory urinary urge incontinence and other voiding disorders. PATIENTS AND METHODS: The outcome measures from all patients in pivotal clinical trials who had undergone sacral nerve stimulation were analysed retrospectively. RESULTS: Neuromodulation was effective in several clinical studies; the response is durable and the benefit-risk profile good. CONCLUSION: Sacral nerve stimulation is becoming the standard of care for refractory overactive bladder and retention problems. The potential benefit of neuromodulation should be included in female urology and gynaecology training programmes.

The national coverage decision for reimbursement for biofeedback and pelvic floor electrical stimulation for treatment of urinary incontinence.

On October 6, 2000, the Centers for Medicare & Medicaid Services (CMS) (formerly the Health Care Financing Administration) issued a national coverage decision for the use of biofeedback and pelvic floor electrical stimulation in the treatment of urinary incontinence. This decision was the first major health care coverage decision made using CMS's new "open" process. The new process included the use of a panel of physicians to evaluate adequacy of evidence to support the utilization of the modalities. From the very beginning, there were indications that CMS was not favorably disposed toward the use of these modalities, and there was a real threat that coverage could be withdrawn or that no decision would be made. The organized and cohesive response of the health care community influenced CMS to make a positive coverage decision. Through the diligent and tenacious work of a group of nurses called the SUNA/WOCN Continence Coalition, professional organizations and prominent individuals were brought together to approach CMS with one message and one voice.

[Analysis of subjective effect, acceptance and costs of conservative treatment of prolapse and incontinence in women]. / Analyse von subjektivem Effekt, Akzeptanz and Kosten der konservativen Behandlung weiblicher Deszensus- und Inkontinenzzustände.

A renaissance of conservative treatment for urinary incontinence and descensus is taking place presently in the German speaking area for pre-surgical improvement of tissue quality as well as for long-term-treatment replacing or postponing surgery. Modern pessaries (shape and material), a more intense and pathophysiological well-founded physiotherapy as well as the support of treatment by electrostimulation and its completion by adequate hormone substitution lead to a successful conservative treatment. "Gesundheitsstrukturreform" (reformatory measures of the German Public Health System), "Fallpauschalen" (flat-rate tariff of treatment by the case) and "Praxisbudgets" (budgets for out-clinic-treatment by the case, also a form of flat-rate tariff) lead to a restriction in prescribing necessary conservative treatment or preventive measures. Assigning the patient to surgical treatment is therefore in large parts favoured (treatment costs are then charged to clinic budgets). On the basis of the presented exemplary cost analysis completed by data on subjective effectiveness, acceptance and evaluation of efforts for patient and doctor we want to show that it is not either method that has to be considered in the treatment but both. Besides we have to treat the patient sequentially-conservative treatment in most cases first, especially in younger women. Conservative treatment thereby offers the possibility to delay or postpone surgery, a very meaningful option offered regarding the relatively poor results of surgery especially in cases of recurrent disease.

Addressing Medicare coverage for biofeedback in the treatment of urinary incontinence.

Clinicians use biofeedback as a tool to assist in muscle re-education when treating patients with urinary incontinence. Although the literature on biofeedback suggests its effectiveness, it lacks consensus and data on the frequency and number of biofeedback sessions necessary. Patient selection for pelvic floor muscle exercise with and without biofeedback is also not clearly identified. Medicare carriers in 21 states have written policies that specifically recognize biofeedback in the treatment of urinary incontinence. In states with these policies, problematic issues include failure to recognize the appropriate biofeedback code, number of services recognized, and bundling other services with biofeedback. In states without a written policy, attention needs to focus on developing a local medical review policy. Clinicians can make a difference by understanding the factors hindering the process, including the inadequacy of the literature and confusion over muscle re-education and the role of biofeedback. There is a need to identify a standard that addresses the diversity of clinicians and their opinions. This article reviews urinary incontinence and the role of biofeedback, focusing on Medicare coverage and how clinicians can help develop local carrier policies to supplement the national policy.

Spina bifida: the personal and financial cost of incontinence.

Spina bifida is a congenital defect in the spinal column in which one or more vertebrae fail to form. The effect of spina bifida on continence is usually complicated by the effect of hydrocephalus on the ability to learn and master the necessary skills to overcome the problems. The childhood and adolescence of some individuals who have spina bifida has been ruined by professionals who chose to ignore the wider implications of severe congenital disability and its effects upon the child's education, personal and social development, and the quality of family life. A holistic approach to management, from birth onwards, should facilitate the interdisciplinary cooperation which is vital if these human tragedies are to be avoided.

Intravaginal maximal electrical stimulation in the treatment of urinary incontinence.

Urinary incontinence imposes a large economic burden, estimated at $10 billion per year. As the cost of health care continues to rise, conservative therapeutic measures are becoming more attractive. Anecdotal reports suggest that electrical stimulation may be up to 87% effective in the treatment of urinary incontinence. Investigators use different stimulation devices and protocols and make a comparison of results difficult. The true efficacy of electrical stimulation for the treatment of urinary incontinence is unknown since there have been no controlled clinical trials. Within our referral-based urogynecology practice, we employ intermittent, intravaginal maximal electrical stimulation in conjunction with bladder drills and pelvic floor exercises. Over a one-year period we treated 76 women with urinary incontinence: 19 with stress incontinence (SUI), 30 with detrusor instability (DI) and 27 with mixed incontinence (MI). After six weeks, our overall objective improvement rate was 76%; 89% of patients with SUI, 73% with DI and 70% with MI met the criteria for improvement. Long-term follow-up averaged 6 months, with a range of 2-12. Of patients who showed an initial objective improvement, 87% maintained that improvement. Intravaginal electrical stimulation may be effective therapy for urinary incontinence. Controlled clinical trials are needed to determine its efficacy and standardize stimulation protocols before its widespread use.