Needs, priorities, and attitudes of individuals with spinal cord injury toward nerve stimulation devices for bladder and bowel function: a survey.

STUDY DESIGN: Survey. OBJECTIVES: To investigate the needs and priorities of people with spinal cord injury for managing neurogenic bladder and bowel function and to determine their willingness to adopt neuromodulation interventions for these functions. METHODS: Anonymous online survey. It was advertised by word-of-mouth by community influencers and social media, and by advertisement in newsletters of advocacy groups. RESULTS: Responses from 370 individuals (27% female, 73% male) were included. Bladder emptying without catheters was the top priority for restoring bladder function, and maintaining fecal continence was the top priority for restoring bowel function. The biggest concerns regarding external stimulation systems were wearing a device with wires connecting to electrodes on the skin and having to don and doff the system daily as needed. The biggest concerns for implanted systems were the chances of experiencing problems with the implant that required a revision surgery or surgical removal of the whole system. Respondents were willing to accept an external (61%) or implanted (41%) device to achieve improved bladder or bowel function. CONCLUSIONS: Bladder and bowel dysfunction remain important unmet challenges for individuals living with SCI who answered our survey. These individuals are willing to accept some potential risks of nerve stimulation approaches given potential benefits. Additional consumer input is critical for guiding both research and translation to clinical use and personalized medicine.

Randomized Clinical Trial Using Sterile Single Use and Reused Polyvinylchloride Catheters for Intermittent Catheterization with a Clean Technique in Spina Bifida Cases: Short-Term Urinary Tract Infection Outcomes.

PURPOSE: Urinary tract infections are common and severe complications in patients with spina bifida. Management includes intermittent bladder catheterization with single use or reused sterile catheters. There is insufficient evidence to set a standard among the different techniques. We determined whether single use polyvinylchloride catheters would reduce urinary tract infections compared to reused polyvinylchloride catheters in patients with neurogenic bladder due to spina bifida. MATERIALS AND METHODS: We performed a 2-arm randomized parallel clinical trial from 2015 to 2016 with an 8-week followup at our center in patients with neurogenic bladder caused by spina bifida. Patients were divided into single use and reused polyvinylchloride catheter groups. Evaluations were done on days 0, 7, 14, 28, 42 and 56. Participants reported symptoms and urine cultures were obtained. The primary outcome was urinary tract infection frequency, defined as positive urine culture plus fever, flank pain, malaise, or cloudy or odorous urine. Study eligibility criteria were age 2 years or greater, spina bifida diagnosis with regular clean intermittent bladder catheterization and no urinary tract infection at initial evaluation. RESULTS: The calculated sample size was 75. Of the patients 135 were screened, 83 were randomized and 75 completed followup. Mean age was 12.7 years (range 2-56) and there were 29 males and 46 females. No statistical difference was found between the single use vs reused catheter groups in the frequency of asymptomatic bacteriuria (32.4% vs 23.7%, p = 0.398) or urinary tract infections (35.2% vs 36.8%, p = 0.877). CONCLUSIONS: Single use polyvinylchloride catheters for intermittent bladder catheterization did not decrease the incidence of urinary tract infections in our patients with neurogenic bladder compared to reused polyvinylchloride catheters. These results are consistent with the 2014 Cochrane Review.

The female experience of ISC with a silicone catheter.

Intermittent self-catheterisation (ISC) is a safe and effective treatment in the management of neuropathic bladder, voiding dysfunction and urinary incontinence in women. ISC has been shown to improve quality of life when used appropriately. It provides freedom for individuals who require bladder drainage as they can choose where and when to catheterise to empty the bladder. ISC requires minimum equipment, is a more discreet solution than an indwelling catheter and is relatively easy to teach in one patient visit. There are a range of different ISC catheters available on prescription. Many have been designed specifically for women and patient choice regarding product selection is an important consideration. This article describes a UK patient-satisfaction survey evaluating the female patient's perspective of learning ISC using a silicone intermittent catheter called HydroSil Go™ that is manufactured by C.R. Bard, Inc.

[Treatment of detrusor-striated sphincter dyssynergia with permanent nitinol urethral stent: results after a minimum follow-up of 2 years]. / Résultats à moyen terme du traitement de la dyssynergie vésicosphinctérienne par sphinctérotomie prothétique permanente.

OBJECTIVES: The aim of this study was to assess the outcomes of nitinol permanent urethral stents used in detrusor-striated sphincter dyssynergia (DSD) treatment on male patients with a spinal cord injury. MATERIALS: We investigated retrospectively all patients treated from 2004 to 2012. A total of 22 patients were included, with an age ranging from 22 to 76 years old. The DSD syndrome was due to spinal cord injury (18) or various spinal cord diseases (four) and treated with a nitinol urethral stent (11 Ultraflex(®) and 11 Mémotherm(®)). Every patient had an urodynamical study. The follow-up reached at least 2 years. RESULTS: The mean follow-up was 56 months (± 14). Complementary procedures after stenting included: five stent prolongation or displacement (mean interval 7.6 months), six bladder neck incisions (12.2 months), three urethrotomy (42 months), ten obstruction treated by laser (47.3 months). Eight patients had a change of their urinary pattern: four underwent ileal conduit diversion, one had a continent urinary diversion, one chose self intermittent catheterization, two were under indwelling catheterization waiting for another treatment. Stent retrieval was either harmful or impossible for four of them. Three patients were free of complementary procedures. CONCLUSIONS: Nitinol urethral stent was an effective treatment initially. However, by the third year, urethral stenosis and hypertrophic growth of the urethral mucosa usually require iterative endoscopic procedures (0.31 per patient per year). Patients treated with permanent uretral stent deserve a yearly endoscopic follow-up. Safety and effectiveness of permanent uretral stent compared to surgical sphincterotomy to treat DSD are discussed.

Use of an inflatable silicone balloon improves the success rate of bladder autoaugmentation at long-term followup.

PURPOSE: Most groups have reported disappointing results with autoaugmentation or detrusor myectomy for low capacity/compliance neuropathic bladders. Failure may be due to an ischemic diverticulum or mucosal shrinkage. We investigated whether a Silimed® silicone balloon placed in the bladder after autoaugmentation could prevent these problems, improving surgical results. MATERIALS AND METHODS: We compared the results of standard bladder autoaugmentation in 12 children (group 1) with those in 10 (group 2) who underwent the same surgery using a bladder conformer. The conformer was a silicone balloon filled with saline that remained in the bladder for 2 weeks. All patients had a neuropathic bladder with poor capacity and compliance, resulting in urinary leakage between catheterizations. Preoperative and postoperative evaluation included a voiding diary, ultrasound, voiding cystourethrogram and urodynamics. RESULTS: In group 1 only 1 patient became dry, 4 had little improvement in continence, 4 remained unchanged and 3 became worse. In group 2, 6 patients (60%) become continent without medication, 2 (20%) become continent with oxybutynin and 2 remained unchanged. Bladder capacity and compliance did not change significantly in group 1. However, in group 2 capacity changed from a mean of 140 to 240 ml and mean ± SD compliance increased from 15.6 ± 16.8 to 34.3 ± 22.8 ml/cm H(2)O (p = 0.02). CONCLUSIONS: The inflatable balloon improved our long-term results of bladder auto-augmentation. A larger series may be necessary to confirm procedure efficacy and safety.

Non-traditional management of the neurogenic bladder: tissue engineering and neuromodulation.

Patients with spina bifida and a neurogenic bladder have traditionally been managed with clean intermittent catheterization and pharmacotherapy in order to treat abnormal bladder wall dynamics, protect the upper urinary tract from damage, and achieve urinary continence. However, some patients will fail this therapy and require surgical reconstruction in the form of bladder augmentation surgery using reconfigured intestine or stomach to increase the bladder capacity while reducing the internal storage pressure. Despite functional success of bladder augmentation in achieving a low pressure reservoir, there are several associated complications of this operation and patients do not have the ability to volitionally void. For these reasons, alternative treatments have been sought. Two exciting alternative approaches that are currently being investigated are tissue engineering and neuromodulation. Tissue engineering aims to create new bladder tissue for replacement purposes with both "seeded" and "unseeded" technology. Advances in the fields of nanotechnology and stem cell biology have further enhanced these tissue engineering technologies. Neuromodulation therapies directly address the root of the problem in patients with spina bifida and a neurogenic bladder, namely the abnormal relationship between the nerves and the bladder wall. These therapies include transurethral bladder electrostimulation, sacral neuromodulation, and neurosurgical techniques such as selective sacral rhizotomy and artificial somatic-autonomic reflex pathway construction. This review will discuss both tissue engineering techniques and neuromodulation therapies in more detail including rationale, experimental data, current status of clinical application, and future direction.

A novel use of dextranomer/hyaluronic acid copolymer.

The aim of this study is to present a novel use of Dextranomer/hyaluronic acid copolymer (Deflux) for the treatment of a complicated iatrogenic chronic urethral injury. A 12-year-old boy with a neuropathic bladder presented a groove in the urethral mucosa due to chronic clean intermittent catheterizations (CICs) and suffered a posterior urethral injury during a failed catheterization for a routine examination. The defect on the urethral wall was repaired using Deflux, a technique that is not described in the literature. After the intervention the patient is continuing CICs without further complications.

Biocarbon urinary conduit: laboratory experience and clinical applications.

A new urinary conduit utilizing pure vitreous carbon has been used successfully in dogs. Pure carbon appears to be inert with respect to urine and urothelium. Lack of urinary salt encrustation on the exposed surface provides a well-functioning urinary conduit for vesical drainage. Twenty-one vesicostomies were performed in dogs. Careful follow-up and histologic studies of removed specimens were done to establish the biocompatibility of pure carbon. All vesicostomies functioned well. A description of the device, protocol, and results of laboratory experimentation are outlined. The surgical procedure is explained in detail. Results encourage the clinical trial of these devices in humans. Indications include patients with neurogenic vesicla dysfunction and those with total urinary incontinence, both of which require permanent indwelling catheters.

Preliminary study of a genetically engineered spinal cord implant on urinary bladder after experimental spinal cord injury in rats.

The objective of this study was to determine the effect of neurotrophin-secreting Schwann cell implants on the urinary bladder after spinal cord contusion. One hour after severe spinal cord contusion at the T8 to T11 level, carbon filaments containing nonsecreting Schwann cells, brain-derived neurotrophic factor (BDNF)-secreting Schwann cells, neurotrophin-3 (NT-3)-secreting Schwann cells, or Schwann cells secreting both BDNF and NT-3 were implanted into the spinal cord. Untreated spinal cord injured (SCI) rats and noncontused rats (C) were also studied. Two months after spinal cord injury, cystometry was performed and the bladders were studied using light microscopy. SCI rats had significantly increased bladder mass, thickness, and smooth muscle mass compared to C rats. Bladder capacity of SCI rats and rats with spinal cord implants were both significantly greater than that of C rats. This preliminary study suggests that neurotrophin-secreting Schwann cell implants may lead to improved bladder structure after spinal cord injury.

Bladder management in patients with pediatric onset neurogenic bladders.

Our objective was to determine which clean intermittent catheterization (CIC) methods and supplies were used by patients with pediatric onset neurogenic bladders and to relate methodology and materials to reported urinary tract infections. Data were collected via questionnaires distributed by mail and at clinic visits at our university tertiary care outpatient pediatric rehabilitation clinic. Questionnaires were given to 165 patients. Fifty-nine percent were returned (68 patients with myelomeningocele, 27 with pediatric onset spinal cord injury (SCI) and two with other diagnoses). Mean age was 12 years (range 1-27). Fifty-four percent of patients participated in their own CIC. Only two percent used sterile catheterization technique, whereas 98 percent used CIC. A sterile catheter was employed with clean technique by 22 percent. Catheters were reused by 76 percent. Subjects used a wide ranging number of catheters per month, with a median of 5.3. There was no correlation between the number of urinary tract infections (UTIs) per year and the type of catheter used or the use of prophylactic antibiotics. Compared with patients with myelomeningocele, subjects with SCI were significantly more likely to use sterile catheters (p = 0.04), > 10 catheters per month (p = 0.01) and gloves (p < 0.001). Subjects who used gloves or more catheters were more likely to experience UTI. These data suggest that clean reused supplies are not related to an increased likelihood of UTI and should be considered a way to lower costs in these populations.

Endoscopic correction of vesicoureteral reflux in patients with neurogenic bladder dysfunction.

Transurethral injection of Teflon paste (TUI) was carried out in 24 ureters of 16 patients with vesicoureteral reflux (VUR) secondary to neurogenic bladder dysfunction at an age ranging from 4 to 77 years, and the results were compared with those of conventional open surgery. During the mean follow-up period of 20.1 months, reflux disappeared in 19 ureters (79%), so that the success rate of endoscopic operation was considered to be satisfactory as compared with that of conventional open surgery, in which reflux disappeared in 16 (80%) of 20 ureters in 16 patients with neurogenic bladder dysfunction at our department. No exacerbation of hydronephrosis was observed postoperatively, and no complication was noted. This procedure, which is minimally invasive and technically simple, may be regarded as the first choice for VUR secondary to neurogenic bladder dysfunction.

[Experience of a double Malecot polyurethane intraurethral catheter in patients with dysuria].

We reviewed our experience of using double Malecot polyurethane intraurethral catheters (IUC). Ten patients with dysuria were treated between April 1991 and April 1993. Seven patients with benign prostatic hypertrophy (BPH) were judged as in a high risk group for operation. The three other patients had neurogenic bladder (two had underactive bladder and 1 had overactive bladder). Under local anesthesia, 150 ml of 0.1% Povidone iodine solution was infused into the bladder through a Nelaton catheter. Under guidance by ultrasonography, an IUC was placed into the bladder neck and posterior urethra using the specially designed introduction set. An long-term follow up of the BPH patients, two IUCs were removed for operation and one was exchanged for an indwelling catheter because of deterioration in general condition. In the neurogenic bladder patients, all IUC were removed because of the increase of residual urine, formation of a pseudourethra, or dislocation into the bladder. Side effects were observed in 6 patients such as, urethral bleeding and stone formation in the stent. Erosion and bleeding tendency in the urethral mucosa were shown in the prolonged duration cases. We conclude that a urethral stent is an effective devise for a high risk patient with benign prostatic hypertrophy but we must keep each patient under strict observation for complications during IUC placement.

Complications of clean intermittent catheterization in young females with myelomeningocele: 10 to 19 years of followup.

PURPOSE: We evaluated the rate of complications associated with catheterization and the risk of urethral lesions in girls with myelomeningocele treated with clean intermittent catheterization for a minimum of 10 years. MATERIALS AND METHODS: We examined the medical records of 31 females with myelomeningocele followed from the start of clean intermittent catheterization until age 11 to 20 years. Catheterization had been performed for a median of 15 years (range 10 to 19). Altogether, catheterization was used for a total of 459 patient-years. Noncoated polyvinyl chloride catheters were used in all cases. Anticholinergic treatment was given during 176 of the patient-years. RESULTS: Complications of catheterization were recorded in 13 patients on 20 occasions. Macroscopic hematuria was seen in 4 individuals. In 2 patients the hematuria was caused by urethral polyps that were cured by resection. Difficulties with catheterization occurred in 12 patients. The problems were solved by temporary use of lubrication or by other minor changes in management. There were no difficulties recorded after puberty. The risk of difficulties at catheterization doubled with the use of a Ch8 to Ch10 catheter compared to a Ch12 or larger catheter, and doubled during assisted clean intermittent catheterization compared to clean intermittent self-catheterization. CONCLUSIONS: There were remarkably few problems associated with clean intermittent catheterization in these females with myelomeningocele, despite long treatment periods and use of noncoated polyvinyl chloride catheters. Clean intermittent self-catheterization and large size catheters were associated with few complications.

Recent advances in intravesical drug/gene delivery.

Targeting of drugs administered systemically relies on the higher affinity of ligands for specific receptors to obtain selectivity in drug response. However, achieving the same goal inside the bladder is much easier with an intelligent pharmaceutical approach that restricts drug effects by exploiting the pelvic anatomical architecture of the human body. This regional therapy involves placement of drugs directly into the bladder through a urethral catheter. It is obvious that drug administration by this route holds advantage in chemotherapy of superficial bladder cancer, and it has now become the most widely used treatment modality for this ailment. In recent years, the intravesical route has also been exploited either as an adjunct to an oral regimen or as a second-line treatment for neurogenic bladder. (Lamm, D. L.; Griffith, J. G. Semin. Urol. 1992, 10, 39-44. Igawa, Y.; Satoh, T.; Mizusawa, H.; Seki, S.; Kato, H.; Ishizuka, O.; Nishizawa, O. BJU Int. 2003, 91, 637-641.) Instillation of DNA via this route using different vectors has been able to restrict the transgene expression in organs other than bladder. The present review article will discuss the shortcomings of the current options available for intravesical drug delivery (IDD) and lay a perspective for future developments in this field.

Intermittent catheterisation with hydrophilic-coated catheters (SpeediCath) reduces the risk of clinical urinary tract infection in spinal cord injured patients: a prospective randomised parallel comparative trial.

OBJECTIVES: To compare the performance of SpeediCath hydrophilic-coated catheters versus uncoated polyvinyl chloride (PVC) catheters, in traumatic spinal cord injured patients presenting with functional neurogenic bladder-sphincter disorders. METHODS: A 1-year, prospective, open, parallel, comparative, randomised, multi centre study included 123 male patients, > or =16 y and injured within the last 6 months. Primary endpoints were occurrence of symptomatic urinary tract infection (UTI) and hematuria. Secondary endpoints were development of urethral strictures and convenience of use. The main hypothesis was that coated catheters cause fewer complications in terms of symptomatic UTIs and hematuria. RESULTS: 57 out of 123 patients completed the 12-month study. Fewer patients using the SpeediCath hydrophilic-coated catheter (64%) experienced 1 or more UTIs compared to the uncoated PVC catheter group (82%) (p = 0.02). Thus, twice as many patients in the SpeediCath group were free of UTI. There was no significant difference in the number of patients experiencing bleeding episodes (38/55 SpeediCath; 32/59 PVC) and no overall difference in the occurrence of hematuria, leukocyturia and bacteriuria. CONCLUSIONS: The results indicate that there is a beneficial effect regarding UTI when using hydrophilic-coated catheters.

Latex allergy manifested in urological surgery and care of adult spinal cord injured patients.

This report exemplifies the cases of two male and one female spinal cord injury (SCI) patients with latex allergy, two of whom had life threatening episodes of intraoperative cardiovascular collapse. The three patients were extensively exposed to latex products as a result of urinary management programs, and two developed marked hypotension immediately upon abdominal exploration during reconstructive urological surgery. The third case represents the development in a male of latex allergy to over 12 types of latex condoms manifest as penile dermatitis. In each of these cases, allergy and immunology consultation confirmed the latex allergy. The diagnosis of latex allergy was established using both Radioallergosorbert (RAST) testing and a skin test to the latex antigen. The two patients who experienced intraoperative cardiovascular collapse required resuscitation with intravenous fluids, epinephrine, and antihistamines. Because each episode of hypotension occurred during bowel manipulation with latex gloves, they were suspected of inducing anaphylaxis. In the third patient, latex allergy was suspected after the immediate resolution of allergic symptoms upon replacing latex condom catheters with those made of silicone. This is the first report of a life-threatening reaction to latex allergy in the SCI population. Measures instituted to prevent further latex-associated morbidity included the use of medical alert bracelets, self-administration epinephrine injection kits, and nonlatex appliances, including gloves, condoms, and urethral catheters. It is recommended that precautions against the development of anaphylaxis be undertaken in SCI patients with chronic exposure to latex-containing products.

Evaluation of direct bladder stimulation with stainless steel woven eye electrodes.

Encouraged by recent clinical reports of micturition induced in patients by direct bladder stimulation, we conducted a study of optimum methods of direct bladder stimulation. During surgery six male cats received eight large surface-area woven eye electrodes sutured to the bladder wall serosa, four on the bladder dome and four adjacent to the trigone area. Two additional small surface-area single knot electrodes were sutured in the trigone area. Suprapubic and intraperitoneal tubes were placed for pressure recording and bladder filling. Leg and pelvic floor EMG electrodes were also used for tethered recordings. One to eight weeks after surgery, optimum stimulation methods were evaluated as the animal freely moved about a urodynamic recording cage. Electrodes in the trigone region were more effective than electrodes on the dome and induced bladder contractions and voiding similar to spontaneously induced voiding with bladder filing. Large surface area, woven eye electrodes, composed of multistranded 316LVM stainless steel wire, were more effective than smaller surface area single knot electrodes. High stimulating frequencies (40 Hz) were better than lower frequencies (10 to 20 Hz), and a 1 millisecond pulse duration was optimal. Pulsing with stimulating currents from 10 to 25 mA induced effective bladder contractions with voiding when applied for 3 seconds. However, lower currents using longer stimulation periods were also effective. Bipolar electrodes with both electrodes on the bladder wall were superior to monopolar arrangements with the positive ground electrode along the animal's back. We concluded that in the able-bodied cat model, bladder contractile activity for micturition can be induced with direct bladder stimulation and with little discomfort. An effective stimulation protocol consists of capacitor-coupled monophasic pulses with large surface area bipolar electrodes in the trigone region. Stimulating parameters of 40 Hz, 1 msec., 10 to 25 mA applied for 3 seconds were optimal. In addition, based on corrosion resistance observations, the electrodes are quite suitable for long-term studies.

The endoscopic correction of reflux by polytetrafluoroethylene injection.

Endoscopic subureteral injection of polytetrafluoroethylene (Teflon) was done in 38 patients (55 ureters) to correct vesicoureteral reflux. Followup excretory urograms and nuclear cystograms were available in 28 patients (40 ureters) 2 to 11 months after injection. Nearly 50 per cent of the patients had a neurogenic bladder. Injection was done for all grades of reflux, although the majority of cases had at least grade III reflux. After injection reflux either was eliminated or decreased in 76 per cent of the patients with neurogenic disease and in 87 per cent of those with a normally innervated bladder. This outpatient procedure is simple and brief to perform, and it is associated with minimal morbidity. As with any new antireflux technique longer followup is indicated.