Sacral neuromodulation: Rechargeable versus non-rechargeable device. What would the patient preferences be in France?

AIMS: Sacral neuromodulation (SNM) is a minimally invasive technique that provides effective treatment for the management of refractory overactive bladder (OAB), non-obstructive urinary retention (NOUR), and fecal incontinence (FI). This study assessed patient preferences between the currently available non-rechargeable SNM device and a new, full-body magnetic resonance imaging (MRI)-safe, smaller, rechargeable device. METHODS: An online cross-sectional survey was conducted among French OAB, NOUR, FI patients, recruited via a market research vendor. To assess their preferences, patients were asked to indicate their level of agreement with 10 statements regarding the size of the device, its rechargeability, and the role of MRI using a 6-item Likert scale. A descriptive statistical analysis was performed. RESULTS: In all, 95 patients (68% women), mean age 50 years, were included in the study: 51% were treated for OAB; 44% received an oral treatment and 28% had SNM. Overall, 71% of the 95 patients indicated a preference for the new device; 75% considered that recharging the device would not impact their lifestyle; 74% believed that the smaller size of the rechargeable device would facilitate their choice to be treated with SNM; 80% found full-body MRI compatibility important. CONCLUSIONS: Most patients may prefer the new rechargeable SNM device over the current "standard". Compatibility with full-body MRI and the smaller device size seemed the key features of the newer device that would influence their choice of being treated with SNM. Future national and international recommendations should consider a shared decision-making process between the physician and the patient.

[Sacral neuromodulation with InterStim™ system: Results from the French national register]. / Neuromodulation sacrée avec le système InterStim™ : résultats du registre national français.

AIM: To analyse current practice patterns and to evaluate (long-term) effectiveness and adverse events of sacral neuromodulation with InterStim™ Therapy based on data collected in a national register and to discuss the strengths and weaknesses of the register. PATIENTS AND METHODS: This is a French multicenter prospective observational trial including patients with a permanent implant (2003-2009). Voiding diary variables and patient satisfaction were analysed based on last follow-up visit since implantation. RESULTS: One thousand four hundred and eighteen patients (median age: 63 years, 1206 females) were included in the database (median follow-up: 12 months). One thousand and eighty-nine patients had non-neurological disease. The principal diagnosis was overactive bladder syndrome ([OAB], n=1170) and retention (n=151). Implantation occurred in 1358 patients; 1172 patients had greater than or equal to one registered follow-up. Clinical improvement of greater than or equal to 50% was seen in 447/527 patients with OAB at 12 months follow-up (median number of voids per 24 hours decreased from 15 at baseline to 8 at 12 months) and in 42/54 of patients with retention (median number of catheterization per 24 hours dropped from 5 at baseline to 0 at 12 months). Clinical improvement remained relatively stable up to 60 months. Median patient satisfaction with treatment was between 60 and 80%. Five hundred and twenty-four patients had at least one adverse event; loss of efficacy (n=244) occurred most frequently. CONCLUSIONS: In this large database sacral neuromodulation with InterStim™ Therapy seems to be an effective treatment through routine practice in the long-term (up to 60 months) for patients refractory to medical treatment.

[Second-line therapy of idiopathic detrusor overactivity. Sacral neuromodulation and botulinum toxin A]. / Second-line-Therapie der idiopathisch überaktiven Blase. Sakrale Neuromodulation und Botulinumtoxin A.

The syndrome of idiopathic overactive bladder (I-OAB) impairs quality of life for the affected individuals. Conservative treatment options such as antimuscarinics are not always effective, and resulting side effects can lead the patient to stop treatment. In recently years, minimally invasive and reversible sacral neuromodulation and botulinum toxin A have become available. Currently, the approved treatment option for I-OAB that is recommended by the International Consultation on Incontinence is sacral neuromodulation by InterStim therapy. This article gives an overview of the present clinical evidence on the effectiveness and reliability of these two treatment modalities as well as the current significance of sacral neuromodulation and botulinum toxin A for the second-line treatment of adult I-OAB.

[Update on the second line management of idiopathic overactive bladder]. / Le point sur les traitements de seconde ligne de l'hyperactivité vésicale idiopathique.

The overactive bladder syndrome (OAB) negatively affects the daily life of many people worldwide and conservative treatments, such as antimuscarinics, not always bring relief and/or are associated with considerable side effects resulting in treatment failure. Second line treatment options used to be invasive surgical procedures. However, less radical, minimally invasive and reversible alternatives, such as sacral neuromodulation and botulinum toxin A have emerged. Of these, only sacral neuromodulation with InterStim Therapy has been approved for OAB and been recommended by the International Consultation on Incontinence (ICI) in 2004. Nevertheless, depending of country rules and habits, both seem to be used by urologists in clinical practice for treating idiopathic OAB (I OAB). Therefore, this review attempts to provide an update on the available clinical evidence concerning the efficacy and safety, and the current position of sacral neuromodulation and botulinum toxin A in the second line management of adults with I OAB.

[Spinal cord injury patient and Brindley neurostimulation]. / Traumatisé médullaire et neuro-stimulation de Brindley.

Electrostimulation of anterior sacral nerve roots has been gradually developed since the 1970s and now represents a real alternative for the treatment of lower urinary tract dysfunction in neurological patients. In some cases, it can also allow improvement of erections and improvement of defecation. The success of the intervention largely depends on rigorous selection of the patients likely to benefit from this technique. In this article, the authors describe the technical principles of this procedure, the ideal patient profile of candidates for this procedure and the main results that can be achieved.

[Intravesical electrostimulation]. / L'electro-stimulation intravésicale.

The intravesical electrostimulation technique is designed to induce a voiding bladder contraction by direct stimulation as an immediate objective and for bladder retraining. This technique appears to be truly effective and is primarily used in paediatric neurourology. It is not widely used at the present time due to the low level of proof of its efficacy and intermittent self-catheterization still remains the treatment of choice in France for neurogenic chronic urinary retention.

[Neuromodulation in the management of neurogenic lower urinary tract dysfunction]. / Neuromodulation dans la prise en charge des troubles vésico-sphinctériens neurologiques.

Various methods using electrical nerve stimulation for neuromodulation can be proposed to patients with neurogenic lower urinary tract dysfunction. However, few studies have reported the results in this specific patient population. In this article, the authors describe the various hypotheses to explain the efficacy of neuromodulation, and the results of the two main neuromodulation techniques currently used in France: sacral neuromodulation and posterior tibial neuromodulation.

Urodynamic monitoring during percutaneous sacral nerve neurostimulation in patients with neurogenic detrusor hyperreflexia.

The purpose of this study was to assess urodynamics parameter changes induced by acute sacral neurostimulation (SNS) in spinal cord injury (SCI) patients with neurogenic detrusor hyperreflexia. Fourteen SCI patients with urge incontinence owing to a hyperreflexive bladder were prospectively evaluated. Neurostimulation was performed on the root that obtained the best motor response (10 Hz, 210 microseconds) and amplitude ranges of >0 to 10 V. The urodynamics study was done in the prone position. Four cystometries were recorded before (two), during (one), and 10 minutes after stimulation (one). Maximal bladder capacity (MBC) (volume to first leakage), bladder volume at first uninhibited contraction (BV(1stC)), and maximal detrusor pressure during uninhibited contractions (P(det)max) were compared. Left S3 foramen was the most commonly used (9/14). Mean amplitude of stimulation was 4.5 V (range, 0.5-8.5 V). Statistically significant differences (Mann-Whitney U-test) were found for MBC, BV(1stC), and P(det)max with mean variations of +206.8 mL (+107%, P < 0.001), +151.5 mL (+98%, P < 0.01), and -23.4 cm H2O (-27%, P < 0.05), respectively. Patient gender and SCI level did not reveal any difference. Patients who reached a MBC of up to 400 mL (+278.2 mL, +129%, n = 10) with SNS had statistically significant improvement of BV(1stC) (+210.2 mL, +125%, P < 0.01) and P(det)max (-33.3 cm H2O, -38%, P < 0.01). Acute temporary SNS in SCI patients has a profound effect on key urodynamics parameters. These neurologically impaired patients with detrusor hyperreflexia may be appropriate candidates for implantable SNS.

Long-term results of sacral nerve stimulation (S3) for the treatment of neurogenic refractory urge incontinence related to detrusor hyperreflexia.

PURPOSE: We assess clinical and urodynamic results of sacral nerve stimulation for patients with neurogenic (spinal cord diseases) urge incontinence and detrusor hyperreflexia resistant to parasympatholytic drugs. MATERIALS AND METHODS: Since 1992, 9 women with a mean age of 42.6 years (range 26 to 53) were treated for refractory neurogenic urge incontinence with sacral nerve stimulation. Neurological spinal diseases included viral and vascular myelitis in 1 patient each, multiple sclerosis in 5 and traumatic spinal cord injury in 2. Mean time since neurological diagnosis was 12 years. All patients had incontinence with chronic pad use related to detrusor hyperreflexia. Intermittent self-catheterization for external detrusor-sphincter dyssynergia was used by 5 patients. Social life was impaired and these patients were candidates for bladder augmentation. A sacral (S3) lead was surgically implanted and connected to a subcutaneous neurostimulator after a positive test stimulation trial. RESULTS: Mean followup was 43.6 months (range 7 to 72). All patients had clinically significant improvement of incontinence, and 5 were completely dry. Average number of voids per day decreased from 16.1 to 8.2. Urodynamic parameters at 6 months after implant improved significantly from baseline, including maximum bladder capacity from 244 to 377 ml. and volume at first uninhibited contraction from 214 to 340 ml. Maximum detrusor pressure at first uninhibited contraction increased in 3, stabilized in 2 and decreased in 4 patients. Urodynamic results returned to baseline when stimulation was inactivated. All patients subjectively reported improved visual analog scale results by at least 75% at last followup. CONCLUSIONS: Sacral nerve stimulation can be used as a reversible treatment option for refractory urge incontinence related to detrusor hyperreflexia in select patients with spinal lesions.

[How to plan the treatment of prostatic adenoma today?]. / Comment concevoir aujourd'hui le traitement de l'adénome prostatique?

Surgical treatment, mainly transurethral resection of the prostate, still remains the reference treatment for benign prostatic hyperplasia (BPH). Two studies conducted in the Urology Department of the Pitié-Salpêtrière Hospital have tried to define certain characteristics of this surgery. The first study tried to evaluate the long-term outcome of patients operated for benign prostatic hyperplasia. Analysis of 881 replies to a questionnaire sent to 3,147 patients operated for BPH (between 1976 and 1989) assessed functional status (by Madsen's symptom score), quality of life (by Fowler's method), and sex life (by two specific questions), with a follow-up ranging from 5 to 14 years. At this follow-up, 90% of patients declared to be satisfied with their voiding status, 95% considered their quality of life to be excellent and about 50% had maintained a sex life. The second study was designed to evaluate the morbidity of this treatment in elderly patients. A group of 33 operated patients over the age of 80 was compared to a control group composed of 66 patients between the ages of 60 and 70 years, treated in a similar way, in the same centre and in the same year. Morbidity was higher in the first group, but age itself did not appear to constitute a poor prognostic factor for surgery; it only intervenes by allowing certain complications of benign prostatic hyperplasia (acute retention) to create emergency situations complicating the perioperative period. Following demonstration of the short-term and long-term efficacy of this conventional surgery, many new technologies were subsequently developed in order to reduce perioperative discomfort, anaesthetic requirements, duration of catheterization and hospital stay. Some of them constitute a new approach to endoscopic surgery, such as prostatic tissue vaporization techniques (electrovaporization, laser contact vaporization), which have a comparable efficacy to that of TURP, while reducing bleeding, catheterization time and hospital stay. However, the duration of postoperative irritative symptoms is much longer. Other techniques use a thermal effect to obtain coagulation necrosis of prostatic tissue, using various energy sources: microwaves (thermotherapy), laser (interstitial laser), radiofrequency waves (TUNA). These techniques are perfectly adapted to outpatient surgery with local or regional anaesthesia. They do not interfere with continence, sexual function, but may be followed by high dysuria or retention rates, with a variable cathererization time, sometimes several weeks. Finally, urethroprostatic stents are easy to insert, provide a solution in critical situations and have replaced old indwelling catheters. The current choice of treatment therefore comprises several approaches: more effective, but still purely symptomatic medical treatment, safe conventional surgery providing excellent long-term results, but generating a certain perioperative discomfort and a certain morbidity, or, on the contrary "minimally invasive" techniques, greatly simplifying the therapeutic procedure, but whose morbidity has not yet been determined and whose results are still uncertain.

Focussed extracorporeal pyrotherapy: experimental results.

A new device made of piezoelectric ceramic placed in a semispherical dish and focussed at 320 mm was developed in order to generate heat and cavitation responsible for coagulative necrosis of deep tissues. The target to be treated is located with a central ultrasound probe of 3.5 MHz. In vitro studies with polyurethane phantoms showed that the ultrasound melted a surface of 2 x 12 mm within 1 s. The temperature recorded at the focus was 270 degrees C. In tissue samples (prostate cancer and benign prostate hyperplasia), the temperature rose to 85 degrees C in vitro and a hyperechoic zone appeared at the focus during shots. In vivo 8-mm plastic spheres, introduced surgically into the bladder of pigs, were melted by repeat shots without burning of crossed tissues. These studies were performed in the kidney and the liver. Autopsy performed on day 0 showed congestion, autopsy performed between day 6 and day 11 showed necrosis, whereas at 3 months the focussed area was fibrosed. This technique, which we called 'focussed extracorporeal pyrotherapy', combines phenomena of cavitation and high heat at the focus. Prostate tumors, bladder tumors, kidney tumors and liver metastases are potential indications for pyrotherapy.