Sacral nerve stimulation for refractory OAB and idiopathic urinary retention: Can phenotyping improve the outcome for patients: ICI-RS 2019?

AIMS: Sacral nerve stimulation (SNS) is widely used to treat refractory idiopathic overactive bladder (OAB) and idiopathic urinary retention. However, clinical outcomes are variable and understanding predictive factors for success or side-effects would enable personalization of therapy and optimization of outcomes. At the International Consultation on Incontinence-Research Society meeting 2019, a Think Tank was convened to discuss how advances in the basic science study of SNS may be translatable into clinical practice to improve outcomes of patients undergoing SNS treatment. METHODS: We conducted a literature review and expert consensus meeting focusing on current methods of phenotyping patients and specifically, how advances in basic science research of the mechanism of action of SNS can be translated into clinical practice to improve patient selection for therapy. RESULTS: The terms "Idiopathic OAB" and "idiopathic urinary retention" encompass several underlying pathophysiological phenotypes. Commonly, phenotyping is based on clinical and urodynamic factors. Animal studies have demonstrated that high-frequency stimulation can produce rapid onset, reversible conduction block in peripheral nerves. Altering stimulation parameters may potentially enable personalization of therapy depending upon the clinical indication in the future. Similarly, advances in conditional and closed-loop stimulation may offer greater efficacy for certain patients. Phenotyping based on psychological comorbidity requires further study to potentially optimize patient selection for therapy. CONCLUSIONS: Idiopathic OAB and idiopathic urinary retention are heterogenous conditions with multiple potential underlying phenotypes. Tailoring stimulation parameters to the needs of each individual according to phenotype could optimize outcomes. Assessing psychological comorbidity may improve patient selection. Areas for further research are proposed.

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial.

AIMS: To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; "NMES") with an FDA-approved intravaginal device (iTouch sure; "comparator device") for the treatment of stress urinary incontinence (SUI). METHODS: This prospective, single-blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving >50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test. RESULTS: Most subjects in both groups achieved >50% reduction in pad weight in the provocative pad test at week 12 (NMES 56.3%; comparator 63.0%), although noninferiority was not established. Significant improvements in pad tests, number of incontinence episodes, and pads used per day, and incontinence quality of life score were seen with both devices at week 12, with no clinically relevant between-group differences. Adverse events were predominantly mild/moderate and there were few discontinuations due to adverse events. The incidence of urinary tract/vaginal infections was higher with the comparator device than the NMES (7.7% versus 0%). The most common device-related adverse effect with the NMES was device discomfort (9.0%), which was generally manageable by modifying the stimulation intensity. CONCLUSIONS: The NMES significantly improved objective and subjective measures of SUI, although statistical noninferiority was not established. The NMES was well tolerated and associated with fewer urinary tract infections than the comparator. The NMES provides a safe, clinically effective, conservative treatment option for female SUI and a low-risk alternative to intravaginal devices.

The efficacy of botulinum toxin A and sacral neuromodulation in the management of interstitial cystitis (IC)/bladder pain syndrome (BPS), what do we know? ICI-RS 2017 think thank, Bristol.

AIMS: This manuscript aims to address the evidence availale in the literature on the efficacy of Botulinum Toxin A (BoNT-A) and sacral neuromodulation (SNM) in patients suffering from Interstitial Cystitis (IC)/BPS and propose further research to identify mechanisms of action and establish the clinical efficacy of either therapy. METHODS: At the International Consultation on Incontinence-Research Society (ICI-RS) in 2017, a panel of Functional Urologists and Urogynaecologists participated in a Think Tank (TT) discussing the management of IC/BPS by BoNT-A and SNM, using available data from both PubMed and Medicine literature searches. RESULTS: The role of BoNT-A and SNM in the treatment of IC/BPS are discussed and mechanisms of actions are proposed. Despite the available randomized trial data on the effect of intravesical BoNT-A treatment on symptoms of IC/BPS, a consistent conclusion of a positive effect cannot be drawn at the moment, as the published studies are small and heterogeneous in design. There is substantive evidence for the positive effects of SNM on symptoms of IC/BPS patients however, during patient selection, it is important to distinguish the degree and the location of pain in order to tailor the best therapy to the right patients. CONCLUSIONS: Both intravesical BoNT-A treatment and SNM have been shown to have positive effects in patients with IC/BPS. However, firm conclusions cannot yet be drawn. Patient-reported outcomes and quality of life should be assessed in addition to urinary and pain symptoms. Since current treatments mainly focus on symptomatic relief, future research should also focus on clarifying the pathogenic mechanisms involved in IC/BPS.

Innovative treatment modalities for urinary incontinence: a European survey identifying experience and attitude of healthcare providers.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence is a common condition in women, with a reported prevalence ranging from 25% to 51%. Of these women, an estimated 38% suffer from stress urinary incontinence (SUI). A European research consortium is investigating an innovative system based on information and communication technology for the conservative treatment of women with SUI. When introducing a new intervention, implementation barriers arise and need to be identified. Therefore, we investigated healthcare providers' experience with and attitude towards innovative care options. METHODS: We performed an online survey to assess (1) the characteristics and practice of healthcare providers, (2) current protocols for SUI, (3) current use of biofeedback, and (4) knowledge about serious gaming. The survey was sent to members of professional societies in Europe (EUGA), UK (BSUG) and The Netherlands (DPFS). RESULTS: Of 341 questionnaires analyzed (response rate between 18% and 30%), 64% of the respondents had access to a protocol for the treatment of SUI, and 31% used biofeedback when treating patients with SUI. However, 92% considered that biofeedback has a clear or probable added value, and 97% of those who did not use biofeedback would change their practice if research evidence supported its use. Finally, 89% of respondents indicated that they had no experience of serious gaming, but 92% considered that it could be useful. CONCLUSIONS: Although inexperienced, European urogynecologists and physical therapists welcome innovative treatment options for the conservative treatment of SUI such as portable wireless biofeedback and serious gaming. Scientific evidence is considered a prerequisite to incorporate such innovations into clinical practice.

Patient preferences for treating refractory overactive bladder in the UK.

OBJECTIVE: To evaluate patient preferences for refractory overactive bladder (OAB) treatments: sacral neuromodulation (SNM), onabotulinum toxin A (Botox(®)), and percutaneous tibial nerve stimulation (PTNS). MATERIALS AND METHODS: A cross-sectional Web survey was conducted with UK idiopathic OAB patients, recruited by a market research company. Preference was explored using direct questioning, comparing SNM, Botox, and PTNS, and via best-worst scaling (BWS). In BWS, patients prioritized subsets of 13 treatment characteristics (attributes) across 13 choice tasks, identifying the attribute they considered best and worst in each task. The attributes were those that were identified by patients in previous qualitative interviews as influential in treatment selection. BWS scores for each attribute, ranging from 1.0 (most favourable) to -1.0 (most unfavourable), were calculated based on the rates they were identified as best and as worst. To identify attributes that may influence treatment choice, BWS scores were compared among patients based on their most preferred treatment using analyses of variance; pairwise differences were assessed using Tukey's multiple comparisons test. RESULTS: The study population (N = 139) was 77 % female, had a mean age of 49 years, and were diagnosed a mean of 6.1 years ago. All 13 attribute BWS scores were viewed positively (score > 0.0) or negatively (score < 0.0). Among the 127 (91 %) of patients who had experience with OAB medication only, most (≥80 %) were willing to try each of the three treatments; 57, 34, and 9 % most preferred PTNS, SNM, and Botox, respectively. Preferences for the attributes differed based on which treatment that patients preferred. Specifically, patients preferring SNM (PS) favoured 'implanted device in upper buttock' more than those preferring PTNS (PP) or Botox (PB). Compared to PB, PS also favoured 'sends signals between bladder and brain to help restore bladder function' and 'test phase'. PB favoured 'Botox (botulinum toxin) treatment' and 'treatment procedure delivered through the urethra' more than PS and PP. PP favoured the following more than PS and PB: 'needle inserted into ankle', 'minimal side effects' and 'treatment requires repeated visits over time'. CONCLUSION: This study identified specific characteristics of specialized therapies for refractory OAB that may significantly influence patient preferences, which may be used to help inform treatment decision-making.

Management of prolapse in older women.

Pelvic organ prolapse (POP) is a common problem affecting 37% of women over the age of 80. Review by a specialist with the aid of a validated quality of life questionnaire will help assess bother, as well as the frequency and severity of urinary, bowel and sexual symptoms. Pelvic examination should be carried out to assess the extent of any prolapse and the compartments affected. The main aim of the treatment is to improve the woman's quality of life. Treatment options may be conservative with lifestyle modifications and pelvic floor muscle therapy, use of a pessary or surgery. Treatment has previously been incorrectly limited in the elderly with the misconception that surgery should be avoided. Her current state of health and expectations are most important. Regardless of age, each patient should be assessed individually with a holistic multi-compartment approach and the risk benefit ratios of every treatment considered.

Does our limited knowledge of the mechanisms of neural stimulation limit its benefits for patients with overactive bladder? ICI-RS 2013.

INTRODUCTION: Neural stimulation has become an established minimally invasive treatment for various lower urinary tract symptoms. The results both short- and long-term are encouraging, however, there is still a lack of knowledge of obvious risk factors, which may affect the outcome of treatment. Although neural stimulation has been embraced by healthcare professionals and patients, the exact mechanism by which neural stimulation works is still unclear. DISCUSSION: A condense review of knowledge available on this topic is presented. Several research questions are raised. Outlines of research studies, both clinical and basic science, are suggested. CONCLUSIONS: Further studies are necessary to understand mechanism of action of neural stimulation and its implications on treatment outcomes.

The management of overactive bladder refractory to medical therapy.

Overactive bladder (OAB) is a clinical syndrome describing the symptom complex of urgency, with or without urgency incontinence and is usually associated with frequency and nocturia. Whilst many women may be initially managed using a clinical diagnosis alone a number will fail primary therapy and will require further investigation. Those women with refractory symptoms following initial conservative and medical therapy may benefit from alternative treatment modalities including intravesical Botulinum toxin, neuromodulation or reconstructive surgery. This review, the second of two covering the treatment of intractable OAB symptoms in women, will focus on management following the failure of medical therapy. It will principally focus on the role of Botulinum toxin, neuromodulation and reconstructive surgery.

What are the causes and consequences of bladder overdistension? ICI-RS 2011.

AIMS: To report the outcome of the think tank on prolonged bladder overdistension from the 3rd ICI-RS meeting. METHODS: Prolonged bladder overdistension was discussed after acute urinary retention, its terminology, its prevalence, pathophysiology, and consequences, as well as prophylactic and therapeutic aspects. RESULTS: Acute prolonged bladder overdistension (ApBO) is a consequence of undetected or inadequately treated acute retention, and is mostly due to regional anesthesia, prolonged childbirth, or extensive surgery. Currently, there is no agreed terminology. A primary, temporary neurogenic detrusor dysfunction causing retention is associated with decreased or absent bladder sensation therefore patients do not complain, and management is delayed. Therapeutically, the first intervention is to drain the bladder. Recovery depends on whether reversible or irreversible damage has occurred. There are no good data to support the use of drugs or sacral neuromodulation. Intravesical electrostimulation is the only treatment that has specifically addressed this problem with encouraging results. There are no recent reports on the effect of surgery for myogenic bladder damage. CONCLUSION: ApBO is an important, but often unrecognized medical complication. There is a need for defining the terminology, for studies to record the incidence of different types of bladder overdistension, and to establish management strategies. Apart from clean intermittent self catheterization (CIC) there are no data justifying pharmacological or other therapies. Therefore, prevention is of paramount importance and there is a need to develop and test preventative strategies, which should then be incorporated in surgical registries.