New Technologies and Applications in Sacral Neuromodulation: An Update.

Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.

AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.

Nocturia: new directions.

The Nocturia Think Tank (TT) met during the 2010 meeting of the International Consultation on Incontinence-Research Society to discuss present knowledge and future directions in care and research of this prominent component of the spectrum of lower urinary tract symptoms. Questions raised included whether nocturia should be re-defined as a function of its bother, effects on quality of life, and economic impact upon society. At issue is the need to delineate the determinants of successful nocturia management. The multifactorial nature of nocturia requires that progress in its treatment will be dependent upon the cooperative investigation on the part of urologists, urogynecologists, geriatricians, epidemiologists, medical economists and pharma. Areas for future avenues of research were outlined at the conclusion of the meeting.

The evaluation and treatment of nocturia: a consensus statement.

What's known on the subject? and What does the study add? Nocturia is currently defined by the International Continence Society (ICS) as the complaint that an individual has to wake at night one or more times to void. It is, however, an underreported, understudied, and infrequently recognized problem in adults. Many factors may contribute to nocturia which are treatable, yet patients do not seek care or the condition may not be identified by providers. This paper aims to help healthcare providers better serve patients who are experiencing nocturia by summarizing current research, clinical approaches, and treatment options. The results of the conference provide a balanced evaluation of the full treatment armamentarium capable of meeting the needs of patients with the manifold causes of nocturia such as nocturnal polyuria, overactive bladder, or benign prostatic hyperplasia.

Cost-effectiveness analysis of sacral neuromodulation and botulinum toxin A treatment for patients with idiopathic overactive bladder.

UNLABELLED: Study Type - Therapy (economic analysis). LEVEL OF EVIDENCE: 1b. OBJECTIVE: To assess and compare the costs and effects value of either starting with sacral neuromodulation (SNM) or botulinum toxin A (BTX) treatment in patients with refractory idiopathic overactive bladder from a societal perspective. MATERIALS AND METHODS: An economic model comparing SNM with BTX was developed. A clinical relevant effect (i.e. success) was defined as 50% or greater reduction in incontinence episodes or urgency frequency symptoms. Information on the clinical effectiveness of the two treatments and on the course of the disease with the two treatments were based primarily on published literature and, when required, on expert opinion. Both treatments were assumed to be performed under general anaesthesia and, for SNM treatment, first-stage tined lead test was used. All costs were based on national data from the year 2008. Analyses from the societal perspective were conducted for a 5-year duration. Costs were discounted at 4% and effects at 1.5%. In addition, different modelling scenarios were used to see determine any changes in the results obtained. RESULTS: Starting with SNM resulted in a higher quality adjusted life year (QALY) gain (difference of 0.23) and a higher cost (difference of €6428) compared to starting with BTX. The corresponding incremental cost-effectiveness ratio was €27,991/QALY. The probability of this ratio being cost effective (e.g. under €40,000/QALY) is 88%. SNM starts to be cost-effective after 4 years. SNM was not cost-effective in some other scenarios, such as when BTX was conducted under local anaesthesia or when peripheral nerve evaluation or bilateral testing was used for SNM. CONCLUSIONS: Starting with SNM, treatment is cost-effective after 5 years compared to BTX. However, in some scenarios, such as the use of local anaesthesia for BTX treatment and SNM peripheral nerve evaluation or bilateral test, SNM was not cost-effective.

Design and validation of a new screening instrument for lower urinary tract dysfunction: the bladder control self-assessment questionnaire (B-SAQ).

OBJECTIVES: To develop and validate a short patient self-assessment screening questionnaire: bladder control self-assessment questionnaire (B-SAQ) for the evaluation of lower urinary tract symptoms. This first validation study was undertaken amongst women. PATIENTS AND METHODS: Three hundred twenty-nine women attending general gynaecology and urogynaecology clinics completed both the B-SAQ and Kings Health questionnaire prior to medical consultation, and independent physician assessment of the presence of lower urinary tract symptoms (LUTS) and need for treatment. The psychometric properties of the B-SAQ were subsequently analysed. RESULTS: The B-SAQ was quick and easy to complete, with 89% of respondents completing all items correctly in less than 5 min. The internal consistency (Cronbach's alpha score 0.90-0.91), criterion validity (Pearson's correlation values of 0.79 and 0.81, p<0.0001 with the incontinence impact domain of the Kings Health questionnaire), and test-retest reliability of the questionnaire were good. The sensitivity and specificity of the questionnaire to identify patients with bothersome LUTS was 98% and 79%, respectively. CONCLUSIONS: LUTS are commonly underreported. Empowering patients to self-assess their bladder symptoms and the need for treatment will improve treatment-seeking behaviour. The B-SAQ is a psychometrically robust, short screening questionnaire that offers patients the ability to assess their bladder symptoms and the bother they cause, and the potential benefit of seeking medical help.