A new bladder-emptying method in females with neurogenic bladder: A randomized, phase II trial.

AIM: To evaluate the performance of the new device compared with clean intermittent catheterization (CIC). METHODS: From March 2015 to March 2018, patients who were admitted to the urologic outpatient clinic. A new intraurethral self-retaining device (ISRD) was made of medical grade silicone and it was inspired by similar catheters that use sliding disks to adjust or fix tubes used to drain the bladder. Patients were randomized into two groups (experimental group [GI]-ISRD vs control group [GII]-CIC). The evaluation was performed at the time of enrollment and 6 months after treatment. Intervention was initiated from the antisepsis of the perineal region and subsequent introduction of the device through the external urethral meatus. The primary outcome was quality of life (QOL). Urinary tract infections (UTIs) episodes, data on urodynamic parameters, adverse effects and number of diapers per day. RESULTS: A total of 177 subjects were analyzed. We found a significant improvement on QOL analysis in the ISRD group (P < .01). ISRD group presented an important reduction (two episodes after ISRD use) on number of UTIs (P < .01) and diaper use, and significant improvement on bladder capacity (80 mL of the average improvement) (P < .01) and compliance (P = .01). Among all registered serious adverse effects, ISRD presented with lower proportion. CONCLUSIONS: The new device has shown to be a safe and promising alternative for adequate emptying of the neurogenic bladder in female patients. Our study has a limitation that is related to a limited period of observation.

[Medical quality standards for selected urological aids and devices : Consensus for patients with neurogenic urinary bladder dysfunction]. / Medizinische Qualitätsstandards ausgewählter urologischer Hilfsmittel : Konsens für Patienten mit neurogenen Harnblasenfunktionsstörungen.

BACKGROUND: Using the CE mark of therapeutic appliances is, on its own, not sufficient enough for their appropriate and effective application. In order to treat the patient successfully, not jeopardizing the success of the treatment, medical quality criteria for therapeutic appliances care are necessary to acceptably compensate for a patient's disabilities. OBJECTIVES: Medical quality criteria are formulated for the most frequently used urological aids and devices, considering hygienic requirements, international literature and the practical experience of physicians and nurses with regard to the care of patients with neurogenic urinary bladder dysfunction. METHODS: An expert group of urologists, surgeons, rehabilitation physicians and nurses has developed medical quality criteria via a structured consensus procedure. Developing these criteria, the group has taken into account current jurisprudence, the current resource directory of neurourological relevant aids, data from international literature and hygiene requirements. RESULTS: Medical quality requirements are discussed and defined for selected groups of urological devices (single use catheters, indwelling catheters, external catheters, urine bags, templates and diapers as well as devices for the electrostimulation of nerves). CONCLUSION: The presented quality requirements offer the possibility to stabilize quality of care with neurourological relevant therapeutic appliances. The catalogue of therapeutic appliances must be urgently updated. Urinal catheters for single use must be classified as an individual product group. Devices for anterior root stimulation and neuromodulation must be included in the resource directory. The incontinence severity classification needs to be reviewed.

Sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction.

STUDY DESIGN: This is a retrospective chart analysis. OBJECTIVES: The objective of this study was to evaluate the effect of sacral neuromodulation (SNM) in patients with neurogenic lower urinary tract dysfunction (NLUTD). SETTINGS: This study was conducted in a spinal cord injury rehabilitation center in Switzerland. METHODS: The charts of all patients who underwent SNM (testing and/or permanent implantation) because of NLUTD at our institution between 2007 and 2013 were evaluated. Treatment outcomes and complications were recorded. RESULTS: A total of 50 patients, 30 women and 20 men, with a mean age of 46 (±14) years, fulfilled the inclusion criteria. The most frequent cause for SNM was spinal cord injury in 35 patients (70%). Median duration of the underlying disease was 9.5 (±9.3) years. In all, 35 patients (70%) received a permanent implant. The complication rate was 16% (8/50). At the last follow-up, SNM was in use in 32 patients. In 26 patients with SNM because of detrusor overactivity, voiding frequency per 24 h was significantly reduced from 9 to 6, and daily pad use rate was significantly improved (2.6 versus 0.6 pads per 24h). On comparing urodynamic assessment of detrusor function before and under SNM, no significant suppression of neurogenic detrusor overactivity (NDO) was detected. In nine patients with chronic neurogenic urinary retention, median postvoid residual urine was significantly reduced from 370 to 59 ml. In all, 94% of the patients were either very satisfied or satisfied with SNM. CONCLUSION: SNM might be an additional therapy option in carefully selected patients with NLUTD. On the basis of our results, urodynamic evaluation before SNM is mandatory, as the procedure does not seem to be suited to significantly alleviate NDO.

[Clinical efficacy on neurogenic bladder after spinal cord injury treated with rehabilitation training and acupuncture-moxibustion].

OBJECTIVE: To compare the differences in the clinical efficacy on neurogenic bladder after spinal cord injury (SCD between the matrix needling technique combined with rehabilitation training and rehabilitation training in the patients. METHODS: Sixty patients of SCI neurogenic bladder were randomized into an observation group (29 cases) and a control group (31 cases). In the control group, the conventional rehabilitation therapy, the intermittent catheterization and bladder function training were adopted, once every day, for 4 weeks totally. In the observation group, on the basic treatment of the rehabilitation as the control group, the matrix needling technique and acupuncture at sanyin points were applied. The treatment of 8 days made one session, at the interval of 2 days, continuously for 3 sessions, meaning 4 weeks totally. The bladder function score, residual urine volume and bladder capacity were compared before and after treatment in the two groups. RESULTS: The bladder function score was reduced after treatment as compared with that before treatment in either group (both P<0. 05). The score in the observation group was lower than that in the control group after treatment (P<0. 05). No matter which spinal segment was injured, the residual urine volume after treatment was reduced as compared with that before treatment and the bladder capacity was increased (P<0. 05). The residual urine volume in the observation group was less than that in the control group after treatment and the bladder capacity was more increased (P< 0. 05). CONCLUSION: The conventional rehabilitation program in combination with the matrix needling technique and acupuncture at sanyin points achieve the significant efficacy on SCI neurogenic bladder.

Comparative cost-effectiveness analysis of sacral anterior root stimulation for rehabilitation of bladder dysfunction in spinal cord injured patients.

BACKGROUND: Urinary disorders account for 10% of deaths in patients with complete spinal cord injury. Sacral anterior root stimulation (SARS) may be a valuable therapeutic option to restore complete and voluntary micturition (CVM), but questions on its cost-effectiveness remain. OBJECTIVE: To evaluate the cost-effectiveness of SARS to restore CVM in patients with complete spinal cord injury. METHODS: We conducted a nonrandomized, multicenter, parallel-group cohort study comparing SARS vs. current medical treatments with catheterization or reflex micturition. CVM was assessed at 12 months (end of follow-up) by urodynamic examination. Medical and nonmedical costs were measured in the perspective of the French national health insurance. Linear regression models were used to estimate the incremental net benefit ((Equation is included in full-text article.); λ = willingness-to-pay) adjusted for potential confounders, and P (INB >0) (i.e., probability of SARS being cost-effective vs medical treatment) for different values of λ. RESULTS: Twenty-five patients were included in each group in 2005 to 2009. At inclusion, mean age was 41 years; 45 (90%) patients were male, and 29 (59%) patients were paraplegic. At 12 months, 15 (60%) patients with SARS had a CVM vs. 3 (12%) patients with medical treatment (P < .001). The total mean cost was 42,803 €; and 8762 €, respectively (P < .001). After adjustment for CVM and voiding methods at inclusion, P (INB >0) was 74% at λ = 100,000 €. This probability was 94% in a sensitivity analysis excluding 6 patients presenting a CVM at inclusion. CONCLUSION: The effectiveness and cost of SARS are much higher than for medical treatment. Our results inform decision makers of the opportunity to reimburse SARS in this vulnerable population.

Intravesical electrostimulation versus sacral neuromodulation for incomplete spinal cord patients suffering from neurogenic non-obstructive urinary retention.

OBJECTIVES: To compare the efficacy of intravesical electrostimulation (IVES) versus sacral neuromodulation (SNM) in patients with incomplete spinal cord lesions (SCL) and neurogenic non-obstructive urinary retention (N-NOR). METHODS: In this retrospective study, 77 N-NOR patients underwent IVES (minimum 28 sessions), then after returning to voiding baseline symptoms, percutaneous first stage of SNM (lasting for minimum 4 weeks). After the two neuromodulation treatments, responders were categorized as patients experiencing both a 50% reduction of volume per catheterization per ml and a 50% reduction in number of catheterizations per day when comparing the 7-day voiding diaries at the end of both procedures to baselines. New urodynamics were performed subsequently. Responders to first stage of SNM underwent permanent SNM. RESULTS: Forty-eight patients responded to neither of the treatments, whereas 29 responded to both IVES and first-stage SNM. No significant statistical differences (P>0.05) were detected in the voiding diaries. Following the two procedures, the first sensation of bladder filling was either maintained or recovered by all responders, whereas the same 11 patients reached a bladder contractility index of >100. The 29 IVES responders lost their clinical benefits in a mean follow-up of 9.6 months. Only 10 out of the 29 patients became nonresponsive to permanent SNM, in a mean follow-up of 54 months. CONCLUSION: A strict correlation in terms of clinical and urodynamic patterns was demonstrated in patients with incomplete SCL and N-NOR, following IVES and first stage of SNM. However, voiding improvement through IVES was short-term when compared with the effects of permanent SNM.

Model-based analysis and design of nerve cuff electrodes for restoring bladder function by selective stimulation of the pudendal nerve.

OBJECTIVE: Electrical stimulation of the pudendal nerve (PN) is being developed as a means to restore bladder function in persons with spinal cord injury. A single nerve cuff electrode placed on the proximal PN trunk may enable selective stimulation of distinct fascicles to maintain continence or evoke micturition. The objective of this study was to design a nerve cuff that enabled selective stimulation of the PN. APPROACH: We evaluated the performance of both flat interface nerve electrode (FINE) cuff and round cuff designs, with a range of FINE cuff heights and number of contacts, as well as multiple contact orientations. This analysis was performed using a computational model, in which the nerve and fascicle cross-sectional positions from five human PN trunks were systematically reshaped within the nerve cuff. These cross-sections were used to create finite element models, with electric potentials calculated and applied to a cable model of a myelinated axon to evaluate stimulation selectivity for different PN targets. Subsequently, the model was coupled to a genetic algorithm (GA) to identify solutions that used multiple contact activation to maximize selectivity and minimize total stimulation voltage. MAIN RESULTS: Simulations did not identify any significant differences in selectivity between FINE and round cuffs, although the latter required smaller stimulation voltages for target activation due to preserved localization of targeted fascicle groups. Further, it was found that a ten contact nerve cuff generated sufficient selectivity for all PN targets, with the degree of selectivity dependent on the relative position of the target within the nerve. The GA identified solutions that increased fitness by 0.7-45.5% over single contact activation by decreasing stimulation of non-targeted fascicles. SIGNIFICANCE: This study suggests that using an optimal nerve cuff design and multiple contact activation could enable selective stimulation of the human PN trunk for restoration of bladder function.

[Modern neurological treatment strategies for patients with spinal cord injury]. / Moderne neurourologische Therapiestrategien bei Patienten mit Rückenmarksschädigung.

Modern treatment methods for neurogenic bladder dysfunction take into consideration the primacy of obtaining good bladder storage capacity by merely lowering the leak point pressure. The medical benefit for the patient is seen in the stability of renal function and the social advantage in achieving continence. The development of modern findings on the management of neuro-urological disorders in spinal cord injury as well as the underlying principles, indications, and benefits of the most frequently applied treatment approaches are described.

[The future of invasive neuromodulation: new techniques and expanded indications]. / Die Zukunft der invasiven Neuromodulation : Neue Techniken und erweiterte Indikationen.

Due to the increasing popularity of neuromodulation, the number of indications and patient groups to which this technique is offered is also increasing. We evaluated the currently available data concerning neuromodulation in geriatric patients, children and patients with spinal cord injury and potential alternatives regarding neural targets and implantation techniques.The evidence of the use of neuromodulation in these patient groups is low. In geriatric patients, the use of neuromodulation seems to be justified. The few existing results concerning neuromulation in children are positive; however, there are no data about long term effects of neuromodulation on the growing organism. In patients with spinal cord injury, neuromodulation by microsurgical nerve anastomosis does not seem to be successful. According to the preliminary data of a single study, neuromodulation in acute spinal cord injury may prevent development of a neurogenic bladder dysfunction. The laparoscopic implantation of electrodes for neuromodulation unfolds new technical opportunities; however, until today there is no proof of the efficacy of this technique. Pudendal neuromodulation appears to be a meaningful addition to the therapeutic armamentarium for selected indications.The existing studies demonstrate the future opportunities of neuromodulation also in geriatric patients, children and patientens with spinal cord injuries. However, especially in the latter two groups, further studies concerning effectiveness and long term consequences are mandatory prior to offering these techniques to patients in everyday practise.

Repetitive lumbosacral nerve magnetic stimulation improves bladder dysfunction due to lumbosacral nerve injury: a pilot randomized controlled study.

BACKGROUND: Rapid rate magnetic stimulation of human sacral nerve roots can reduce stress incontinence. OBJECTIVE: To test stimulation for urgency incontinence due to lumbosacral plexopathy. METHODS: The authors studied patients with intractable neurogenic urinary dysfunction due to lumbosacral nerve injuries. Eligible patients were randomized to receive either real or sham repetitive lumbosacral magnetic stimulation (rLMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using rating scales to score urinary dysfunction and a visual analogue scale (VAS) to assess lower back pain. Posterior tibial nerve F-wave and H-reflexes were tested before and after treatment. RESULTS: Both treatment and control groups were comparable for baseline characters and sphincteric disturbances. The mean number of voids and incontinence per 24 hours was significantly reduced in patients who received rLMS. The improvement was maintained 1 month after the end of treatment. Patients receiving real-rLMS also reported an improvement in VAS ratings. Improvement in F-wave and H-reflex latencies after real stimulation (P = .002 and P = .036, respectively) was found as well. CONCLUSION: rLMS at 15 Hz may improve urinary dysfunction secondary to lumbosacral nerve injury. Further trials can determine the profile of patients who may benefit and optimal stimulation parameters.

Patient preferences for next generation neural prostheses to restore bladder function.

STUDY DESIGN: A survey administered to 66 individuals with spinal cord injury (SCI) implementing a choice-based conjoint (CBC) analysis. Six attributes with three levels each were defined and used to generate choice sets with treatment scenarios. Patients were asked to choose the scenario that they preferred most. OBJECTIVES: To determine the utility weights for treatment characteristics as well as the overall preference for the three types of neural prostheses (NP), that is Brindley, rhizotomy-free Brindley, and pudendal nerve stimulation. Earlier studies have revealed the importance of restoration of bladder function, but no studies have been performed to determine the importance of NP features. SETTING: Two academic affiliated medical systems' SCI outpatient and inpatient rehabilitation programs, Cleveland, OH. METHODS: CBC analysis followed by multinomial logit modeling. Individual part-worth utilities were estimated using hierarchical Bayes. RESULTS: Side effects had the greatest significant impact on subject choices, followed by the effectiveness on continence and voiding. NPs with rhizotomy-free sacral root stimulation were preferred (45% first choice) over pudendal afferent nerve stimulation (39% second choice) and sacral root stimulation with rhizotomy (53% third choice). Almost 20% did not want to have an NP at all times. CONCLUSION: CBC has shown to be a valuable tool to support design choices. The data showed that persons would prefer a bladder NP with minimally invasive electrodes, which would give them complete bladder function, with no side effects and that can be operated by pushing a button and they do not have to recharge themselves.

Electrocardiographic artifact induced by an electrical stimulator implanted for management of neurogenic bladder.

Serial electrocardiograms (ECGs) obtained in a 79-year-old woman revealed consistently sharp regular high-voltage spikes, which were superimposed on her ECG curve, and which were caused by an implanted pelvic electrical stimulator used for the management of a neurogenic bladder, with symptoms of urinary urgency and incontinence.

Bladder emptying by intermittent electrical stimulation of the pudendal nerve.

Persons with a suprasacral spinal cord injury cannot empty their bladder voluntarily. Bladder emptying can be restored by intermittent electrical stimulation of the sacral nerve roots (SR) to cause bladder contraction. However, this therapy requires sensory nerve transection to prevent dyssynergic contraction of the external urethral sphincter (EUS). Stimulation of the compound pudendal nerve trunk (PN) activates spinal micturition circuitry, leading to a reflex bladder contraction without a reflex EUS contraction. The present study determined if PN stimulation could produce bladder emptying without nerve transection in cats anesthetized with alpha-chloralose. With all nerves intact, intermittent PN stimulation emptied the bladder (64 +/- 14% of initial volume, n = 37 across six cats) more effectively than either distention-evoked micturition (40 +/- 19%, p < 0.001, n = 27 across six cats) or bilateral intermittent SR stimulation (25 +/- 23%, p < 0.005, n = 4 across two cats). After bilateral transection of the nerves innervating the urethral sphincter, intermittent SR stimulation voided 79 +/- 17% (n = 12 across three cats), comparable to clinical results obtained with SR stimulation. Voiding via intermittent PN stimulation did not increase after neurotomy (p > 0.10), indicating that PN stimulation was not limited by bladder-sphincter dyssynergia. Intermittent PN stimulation holds promise for restoring bladder emptying following spinal injury without requiring nerve transection.

Implantable FES system for upright mobility and bladder and bowel function for individuals with spinal cord injury.

STUDY DESIGN: Postintervention. OBJECTIVES: To determine the effectiveness of the Praxis multifunctional implantable functional electrical stimulation (FES) system (Neopraxis Pty. Ltd, Lane Cove, NSW, Australia) to provide standing and stepping ability and bladder and bowel management for individuals with motor complete thoracic level spinal cord injuries (SCI). SETTING: Pediatric orthopedic hospital specializing in SCI. SUBJECTS: Three males, ages 17 and 21 years, with motor-complete thoracic level SCI and intact lower motor neurons to the muscles targeted for stimulation. METHODS: Each subject was successfully implanted with the Praxis FES system. All three subjects received electrodes for upright mobility and the first two subjects received additional electrodes for stimulated bladder and bowel management. Following training, subjects were evaluated in their ability to use FES for nine mobility activities. Acute and chronic experiments of the effect of stimulation on bowel and bladder function were also performed. RESULTS: All three subjects could independently stand up from the wheelchair and could walk at least 6 m using a swing through gait pattern. Two subjects were able to independently perform swing through gait for 6 min and one subject was able to independently ascend and descend stairs. Suppression of reflex bladder contractions by neuromodulation (subject 1) and stimulated contractions of the rectum (subject 2) were observed in acute experiments. When stimulation was applied over the course of several weeks, a positive effect on bowel function was measured. Stimulated bladder contractions were not achieved. CONCLUSION: The feasibility of using the Praxis FES system for upright mobility and aiding aspects of bladder and bowel function was demonstrated with three subjects with thoracic level SCI.

[Management of neuropathic bladder in multiple sclerosis]. / Management della vescica neurologica nella sclerosi multipla.

It is estimated that almost 70% of patients affected by multiple sclerosis (MS) suffer from urinary symptoms, with devastant impact on Quality of Life (QoL). The major aims of management should be to ameliorate the patients quality of life and to prevent the frequent complications of bladder dysfunction such as infention and renal damage. Therapy can usually eliminate or reduce the symptoms of neuropathic bladder. In the following pages is discussed the complex management of urinary symptoms in MS patients.

Deafferentation of the urinary bladder and implantation of a sacral anterior root stimulator (SARS) for treatment of the neurogenic bladder in paraplegic patients.

Since 25 years electrical stimulation has become an established and widely acknowledged therapy option. Today, FES is widely employed, e.g. for cardiostimulation, diaphragm stimulation, kinetotherapy, for treatment of tremor in Parkinson patients, and finally for bladder stimulation in patients with bladder voiding dysfunctions. Brindley was the first researcher who succeeded in stimulating the spinal nerves via implanted electrodes in an animal model. In the years 1978/79 Brindley implanted five paraplegic patients with so-called sacral anterior root stimulators; all of them were able to void under stimulation. This method of sacral anterior root stimulation (SARS) proved an alternative to frequent one-way catheterisation for patients with severe voiding dysfunctions, without achieving complete continence, however. The following study is to provide an overview over the latest insights in the context of implanting sacral anterior root stimulators; it discusses the preconditions required for such interventions and presents criteria to decide in which cases there is a contraindication for sacral deafferentation of the posterior roots. Moreover, it contrasts advantages and disadvantages of the intradural and extradural implantation methods and presents the currently available long-term follow-up results with SDAF and SARS for treatment of bladder voiding dysfunctions.

Self-controlled dorsal penile nerve stimulation to inhibit bladder hyperreflexia in incomplete spinal cord injury: a case report.

Intermittent catheterization is not always successful in achieving continence in spinal cord injury (SCI) and often requires adjunctive methods. Electric stimulation of sacral afferent nerves reduces hyperactivity of the bladder. This report describes application of self-controlled dorsal penile nerve stimulation for bladder hyperreflexia in incomplete SCI. The patient was a 33-year-old man with C6 incomplete quadriplegia who managed his bladder with intermittent self-catheterization and medication. Despite this, he continued to have reflex bladder contractions that he could feel but could not catheterize himself in time to prevent incontinence. We performed cystometry with dorsal penile nerve stimulation and analyzed data of home use of stimulation. During cystometry, the suppressive effect of electric stimulation on hyperreflexic contractions was reliable and reproducible. The patient could start stimulation on sensing bladder contraction, and the suppression of reflex contraction lasted several minutes after stopping brief stimulation. When using stimulation at home, the rate of leakage between catheterization decreased, and catheterized volume increased significantly.

Functional electrical stimulation of bladder and bowel in spinal cord injury.

The purpose of this collective review is to examine the use of functional electrical stimulation for incontinence. The Finetech-Brindley bladder system enhances voiding through stimulation via electrodes implanted around the ventral sacral roots. Detrusor hyperreflexia is eliminated through complete dorsal rhizotomy, which results in loss of reflex defecation and reflex erection/reflex lubrication. Consequently, a new system is being devised in which functional electrical stimulation for incontinence in spinal cord injury can be achieved without dorsal rhizotomy.