Solifenacin is effective and well tolerated in patients with neurogenic detrusor overactivity: Results from the double-blind, randomized, active- and placebo-controlled SONIC urodynamic study.

AIMS: To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity (NDO) due to multiple sclerosis (MS) or spinal cord injury (SCI). METHODS: SONIC was a prospective, multicenter, double-blind, phase 3b/4 study investigating the efficacy and safety of solifenacin 10 mg in patients with NDO due to MS or SCI. Patients (n = 189) were randomized to placebo or active treatment (solifenacin 5 mg, 10 mg or oxybutynin hydrochloride 15 mg) for 4 weeks, after a 2-week, single-blind, placebo run-in period. The primary endpoint was change in maximum cystometric capacity (MCC) from baseline to end of treatment. The primary analysis compared solifenacin 10 mg versus placebo; all other comparisons were considered secondary. Secondary endpoints included changes in urodynamic parameters, patient-reported outcomes, and safety assessments. RESULTS: In the primary analysis, solifenacin 10 mg significantly improved mean change from baseline MCC versus placebo (P < 0.001) and was associated with improvements in bladder volume at first contraction and at first leak as well as detrusor pressure at first leak. Similar results were obtained for oxybutynin versus placebo. Patient perception of bladder condition significantly improved with solifenacin 10 mg versus placebo (P = 0.041). There was a clear improvement in quality of life (QoL) in the solifenacin arms versus placebo. The overall incidence of adverse events was low. CONCLUSIONS: In patients with NDO due to MS and SCI, 4 weeks of treatment with solifenacin 10 mg improved urodynamic variables and QoL versus placebo and was well tolerated. Neurourol. Urodynam. 36:414-421, 2017. © 2015 Wiley Periodicals, Inc.

Treatments for erectile dysfunction in spinal cord patients: alternatives to phosphodiesterase type 5 inhibitors? A review study.

STUDY DESIGN: Review study. OBJECTIVES: Alternative treatments to oral phosphodiesterase type 5 inhibitors (PDE5Is) in individuals with spinal cord lesions (SCLs) and erectile dysfunction (ED). SETTING: Italy. METHODS: Research clinical trials (1999-2014). RESULTS: Twelve studies were selected. One article documented that 76% of subjects reached satisfactory sexual intercourse (SI) using intracavernosal injection of vasoactive medications (papaverine and prostaglandin E1). One study regarding perineal training showed a significant increase (P<0.05) in penile tumescence in 10 individuals with preserved sacral segment. Two studies reported contrasting results on erectile function (EF) using various dosages of oral fampridine (25-40 mg). Furthermore, 95.1% of patients on fampridine 25 mg experienced drawbacks. Disappointing findings were found with intraurethral alprostadil (125-1000 µg) and sublingual apomorphine 3 mg. Two studies concerning penile prosthesis reported valid SI more than 75% of the time with a mean follow-up of 11 years, although around 15% of individuals showed side effects. As for surgical treatments, 88% of males submitted to Brindley sacral anterior root stimulator after sacral dorsal rhizotomy achieved valid erection up to 8 years following the procedure. Three studies documented the impact of definitive sacral neuromodulation implant (Medtronic, Minneapolis, MN, USA) also on EF. After surgery, 20-37.5% of patients with ED recovered normal EF. CONCLUSIONS: Data are scant on the efficacy of ED treatments for SCL subjects who did not respond to PDE5Is. Further research should investigate the effects of any SCL treatments even when they are not strictly used for neurogenic sexual dysfunction.

Sacral neuromodulation for neurogenic non-obstructive urinary retention in incomplete spinal cord patients: a ten-year follow-up single-centre experience.

OBJECTIVE: To determine the success rate of percutaneous first stage of sacral neuromodulation (SNM) and the efficacy and safety of permanent SNM for incomplete spinal cord lesion (SCL) patients suffering from chronic neurogenic non-obstructive urinary retention (N-NOR). METHOD: From January 2003 to December 2012, 85 individuals underwent the percutaneous first stage of SNM. Subsequently, only responders who reached a concomitant reduction by at least 50% of volume per catheterization and in the number of catheterizations per day comparing their 7-day voiding diaries at baseline underwent permanent SNM. Final follow-up was conducted by April 2013. RESULTS: Thirty-six individuals responded to percutaneous first stage of SNM. Post-surgery urodynamics documented all patients experiencing first sensation of bladder filling. A statistically significant increase in Qmax ml per sec and decrease in post-voiding residual urine per ml were documented. (P<0.01). First sensation of bladder filling at baseline represented a statistically significant parameter for the success of the first stage SNM (P<0.05). Eleven out of 34 patients at follow-ups were 'inconstant responders' because they returned to similar baseline voiding symptoms, but responded again with an implant on the controlateral S3 sacral root. Two failed twice and responded once again after an S4 sacral root implant. All but one failure occurred more than 3 years after the previous implant. Other drawbacks were resolved telemetrically. CONCLUSIONS: Research is needed to increase the success rate of the first stage SNM on incomplete SCL patients with N-NOR. Permanent SNM is highly efficacious in the medium follow-up.

Clinical efficacy of intravesical electrostimulation on incomplete spinal cord patients suffering from chronic neurogenic non-obstructive retention: a 15-year single centre retrospective study.

OBJECTIVE: To evaluate the clinical and urodynamic impact of intravesical electrostimulation (IVES) on incomplete spinal cord injury (SCI) patients suffering from chronic neurogenic non-obstructive urinary retention (N-NOR). METHODS: One-hundred and two patients underwent at least 28 consecutive daily IVES sessions because objective evidence of detrusor acontractility instead of hypocontractility was detected. Diary entries written at various stages by each patient were compared (7 days before the IVES cycle, 15-21 days into the cycle and 7 days before its end). Responders were patients with a mean 50% reduction in both the number of daily catheterizations and post-void residual urine. Responders underwent further urodynamics at the end of the IVES cycle; patients experiencing first sensation of bladder filling, and the mean volume of first sensation of bladder filling per ml, Qmax ml s(-1), among others, were evaluated. Nineteen individuals who repeated another IVES round were included in this study. RESULTS: Thirty-eight subjects (37.2%) responded to IVES and of those, 83.3% recovered the first sensation of bladder filling after the IVES round. Nineteen responders repeated IVES within 1 year, owing to loss of efficacy. They obtained similar voiding symptoms improvement and urodynamic results as after the first IVES cycle. A timespan of <2 years from SCI to IVES, and the presence of first sensation of bladder filling at baseline represented significant predictive parameters for IVES success (P<0.05) using χ(2)-test. CONCLUSIONS: IVES represents a possible therapeutic option for incomplete SCI patients with N-NOR.

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.

A retrospective study on female urological surgeries over the 10 years following spinal cord lesion.

OBJECTIVES: To evaluate the efficacy and safety over a 10-year period of any urological operations required by female patients with spinal cord lesions (SCLs). METHODS: Retrospective study of urological surgeries from our database performed on females with SCLs from 2001 to 2002. Surgery efficacy for neurogenic lower urinary tract dysfunctions (N-LUTDs) was evaluated by comparing 7-day voiding diaries pre- and post-surgeries, while individual investigations were done pre- and post-surgery to evaluate urological complications. Drawbacks were assessed. RESULTS: Thirty-eight out of 69 patients underwent one or more urological procedures. Twenty-one out of 42 patients with suprasacral lesions underwent interventions for N-LUTD. The main surgical treatment was endoscopic detrusor infiltration of botulinum-A (Botox 300 UI or Dysport 750 UI) performed 107 times on 15 subjects using aseptic intermittent catheterizations for neurogenic overactive bladder. Mean efficacy duration was 9.2 months. Six females with infrasacral lesions underwent at least one intervention for N-LUTD. Two females in each group underwent tension-free vaginal tape for stress urinary incontinence (SUI), reducing episodes per week of SUI by >90% after 5 years. The most serious urological complication was active vesico-ureteral reflux (VUR) in three patients, treated endoscopically with submucosal injection of Macroplastique. No VUR recurrence was detected during a 6-year follow-up. All bladder stones (five cases) and renal calculi (five cases) were treated with endoscopic transurethrally electrohydraulic lithotripsy and extracorporeal shock-wave lithotripsy, respectively. Overall, no serious drawbacks were observed. CONCLUSIONS: Mini-invasive surgeries were exclusively used to address urological issues in chronic SCL patients.

The use of oxybutynin in patients treated by means of botulinum neurotoxin A for neurogenic detrusor overactivity: an observational study.

STUDY DESIGN: This is an observational prospective noncontrolled study. We enrolled 105 patients affected by neurogenic detrusor overactivity (NDO) who underwent botulinum neurotoxin A (BONT-A) intradetrusor injection and were followed-up for 270 days. OBJECTIVES: To investigate the use of oxybutynin after BONT-A administration in NDO patients. SETTING: Careggi University Hospital in Florence and Tor Vergata University Hospital in Rome. METHODS: Prospective data from two Italian centers were collected in 1 year. Patients showing limited efficacy but good tolerability and adherence to oxybutynin 5 mg three times a day (t.i.d.). were enrolled in the study. Patients received BONT-A intradetrusor injection (onabotulinumtoxinA, 300 U) with a trigone-sparing technique, and the use of oxybutynin was registered at every visit. RESULTS: 105 patients were included. At visit 1, only 30 patients (28.6%) used oxybutynin t.i.d., whereas 47 (45,2%) used a lower dosage and 28 (26.7%) stopped the therapy. At visit 2, 77.3% of patients who had reduced oxybutynin intake, maintained the dosage decided at visit 1. At visit 3, 51.9% returned to oxybutynin t.i.d.; 44.8% were on a reduced dosage and only 3 (2.9%) were not taking the drug. At visit 4, only 37.5% of patients were taking less than oxybutynin t.i.d. CONCLUSION: This study provides some important insights on the use of oral antimuscarinics in patients treated by means of BONT-A intradetrusor administration for NDO; in particular, it suggests that, after an initial reduction in the use of oxybutynin, patients tend to increase the dosage of this drug during the follow-up after the BONT-A treatment.

Decoding bladder state from pudendal intraneural signals in pigs.

Neuroprosthetic devices used for the treatment of lower urinary tract dysfunction, such as incontinence or urinary retention, apply a pre-set continuous, open-loop stimulation paradigm, which can cause voiding dysfunctions due to neural adaptation. In the literature, conditional, closed-loop stimulation paradigms have been shown to increase bladder capacity and voiding efficacy compared to continuous stimulation. Current limitations to the implementation of the closed-loop stimulation paradigm include the lack of robust and real-time decoding strategies for the bladder fullness state. We recorded intraneural pudendal nerve signals in five anesthetized pigs. Three bladder-filling states, corresponding to empty, full, and micturition, were decoded using the Random Forest classifier. The decoding algorithm showed a mean balanced accuracy above 86.67% among the three classes for all five animals. Our approach could represent an important step toward the implementation of an adaptive real-time closed-loop stimulation protocol for pudendal nerve modulation, paving the way for the design of an assisted-as-needed neuroprosthesis.

Sacral nerve modulation in the treatment of chronic pain after pelvic surgery.

AIM: The aim of the study was to evaluate the efficacy of sacral nerve modulation for chronic pelvic pain after pelvic or anal surgery for benign disease. METHOD: From January 2004 to December 2009, 17 (14 female; age 56 years) consecutive patients suffering from chronic pelvic pain underwent evaluation for sacral nerve modulation in three pelvic floor units. RESULTS: The previous surgery included stapled transanal rectal resection (five), hysterectomy (four), haemorrhoidectomy (two), stapled haemorrhoidopexy (one), fistulectomy (one), urethral sphincterotomy (one), appendicectomy (one), discectomy (one) and laparoscopy for endometriosis (one). Eight (47%) patients fulfilled the criteria for definitive implantation and were followed for a mean of 39 months. Using a visual analog pain score, pain levels fell from 8.2 preoperatively to 1.9, 2.1, 2.0 and 1.8 at 6, 12, 24 and 36 months, respectively. Age < 60 years and duration of symptoms of < 24 months were good predictors and stapling was a poor predictor of success. CONCLUSION: Sacral nerve modulation seems to be effective over time in some patients with chronic pain related to previous surgery.

Controversy over the pharmacological treatments of storage symptoms in spinal cord injury patients: a literature overview.

STUDY DESIGN: Our aim was to locate research and communicate the evidence found from scientific studies pertaining to the treatment of neurogenic detrusor overactivity (NDO) in the chronic stage of spinal cord injury (SCI). OBJECTIVE: To address the controversy over the traditional (antimuscarinics) and the 'new' treatments for NDO and try to offer an insight on the rationale underlying the development of new drugs such as botulinum toxin (BTX), vanilloids, nociceptin/orphanin FQ. As a final point, to provide information on a new class of cation channels, the Degenerin/Epithelial Na(+)Channel (Deg/ENaC) Family that could be future targets for the management of NDO. SETTING: International. METHODS: Overview of English literature on drug management of NDO. RESULTS: Agents that block the 'efferent' function of micturition reflex, such as antimuscarinics, are currently first-line therapy for NDO. They reach the highest level of evidence (1a) and grade of recommendation (A). However, many patients and physicians believe that the 'efferent' pharmacological management of NDO is not completely satisfactory. Consequently, research is trying to address issues of efficacy, tolerability and convenience of new therapeutic strategies targeting the 'afferent' function. CONCLUSION: Antimuscarinic therapy increases the bladder capacity and delays the initial urge to void. However, in some patients they fail to achieve the patient's therapeutic goals. New interesting approaches have been investigated in the last few years. BTX seems to be very promising in treating neurogenic overactive bladder (OAB), but other compounds are now on the horizon.

Insight into new potential targets for the treatment of overactive bladder and detrusor overactivity.

Although overactive bladder (OAB) and detrusor overactivity (DO) are not synonyms, they share therapeutic options and partially underlying physiopathological mechanisms. The aim of this overview is to give insight into new potential targets for the treatment of OAB and DO. A narrative review was done in order to reach this goal. Ageing, pelvic floor disorders, hypersensitivity disorders, morphologic bladder changes, neurological diseases, local inflammations, infections, tumors and bladder outlet obstruction may alter the normal voluntary control of micturition, leading to OAB and DO. The main aim of pharmacotherapy is to restore normal control of micturition, inhibiting the emerging pathological involuntary reflex mechanism. Therapeutic targets can be found at the levels of the urothelium, detrusor muscles, autonomic and afferent pathways, spinal cord and brain. Increased expression and/or sensitivity of urothelial-sensory molecules that lead to afferent sensitization have been documented as a possible pathogenesis of OAB. Targeting afferent pathways and/or bladder smooth muscles by modulating activity of ligand receptors and ion channels could be effective to suppress OAB.

An overview on mixed action drugs for the treatment of overactive bladder and detrusor overactivity.

OBJECTIVES: To provide an overview on the efficacy, tolerability, safety and health-related quality of life (HRQoL) of drugs with a mixed action used in the treatment of overactive bladder (OAB). EVIDENCE ACQUISITION: MEDLINE database and abstract books of the major conferences were searched for relevant publications from 1966 to 2011 and using the key words 'overactive bladder', 'detrusor overactivity', 'oxybutynin', 'propiverine', and 'flavoxate'. Two independent reviewers considered publications for inclusion and extracted relevant data, without performing a meta-analysis. EVIDENCE SYNTHESIS: Old and conflicting data do not support the use of flavoxate, while both propiverine and oxybutynin were found to be more effective than placebo in the treatment of OAB. Propiverine was at least as effective as oxybutynin but with a better tolerability profile even in the pediatric setting. Overall, no serious adverse event for any product was statistically significant compared to placebo. Improvements were seen in HRQoL with treatment by the oxybutynin transdermal delivery system and propiverine extended release. CONCLUSIONS: While there is no evidence to suggest the use of flavoxate in the treatment of OAB, both oxybutynin and propiverine appear efficacious and safe. Propiverine shows a better tolerability profile than oxybutynin. Both drugs improve HRQoL of patients affected by OAB. Profiles of each drug and dosage differ and should be considered in making treatment choices.

Recommendations for the management of urinary disorders in multiple sclerosis: a consensus of the Italian Multiple Sclerosis Study Group.

Urinary disorders are uncommon in the initial phases of multiple sclerosis, but increase in frequency as the disease progresses, with a negative impact on quality of life. The goal of this study was to propose a protocol for the diagnosis and treatment of urinary disorders in multiple sclerosis, based on data from the scientific literature and the experience of Italian clinical centres. In particular, the following clinical aspects were considered: what to do with patients with asymptomatic multiple sclerosis; what to do with symptomatic patients; how and when to perform a second-level diagnostic evaluation; and how to treat urinary disorders. A diagnostic-therapeutic algorithm is proposed, that can be applied in Italian clinical centres.

Clinical concomitant benefits on pelvic floor dysfunctions after sacral neuromodulation in patients with incomplete spinal cord injury.

OBJECTIVES: To assess the concomitant clinical improvement in incomplete spinal cord injury patients (SCIPs) suffering from neurogenic bowel symptoms (NBSs), neurogenic lower urinary tract symptoms (NLUTSs) and neurogenic erectile dysfunction (NED) using sacral neuromodulation (SNM) for NBSs and NLUTSs. METHODS: Seventy-five SCIPs were selected. Before and during the follow-ups post-SNM, NLUTSs and NBSs were detected mainly through specific diaries. Erectile function was assessed using the International Index of Erectile Function composed of 5 questions (IIEF5). Quality of life (QoL) was measured with the Short Form 36 Health Survey questionnaire (SF-36). During the first stage, in which a permanent electrode was inserted percutaneously into the third sacral foramina and stimulated using an external generator, patients with NBSs or NLUTSs were required to improve their symptoms by at least 50% compared with baseline before proceeding to the second stage in which the generator was placed in the patient's buttock. NED patients needed to increase their IIEF5 score by at least 25% compared with baseline (evaluated initially 3 months after the second stage) in order to continue follow-up. RESULTS: Fourteen out of 37 subjects who manifested two functional pelvic dysfunctions at baseline maintained notable clinical improvement in two pelvic functions (median follow-up >3 years). Six had non-obstructive retention (NOR) and NED, six double incontinence, and two constipation with NOR. In the general and mental health domains of the SF-36, all patients improved their scores by at least 20% compared with baseline. CONCLUSIONS: SNM may be beneficial to selected incomplete SCIP with concomitant pelvic functional disturbances.

Clinical outcome of sacral neuromodulation in incomplete spinal cord-injured patients suffering from neurogenic bowel dysfunctions.

STUDY DESIGN: Retrospective study. OBJECTIVES: Efficacy and safety of sacral neuromodulation (SNM) in incomplete spinal cord-injured patients (SCIPs) affected by chronic neurogenic bowel symptoms (NBSs). SETTING: Neurourology Department. Primary to tertiary care. METHODS: Retrospective non-blinded study without controls. Thirty-nine SCIPs were submitted to temporary stimulation for NBS. Permanent implantation was carried out if both their NBSs improved and the Wexner questionnaire scores were reduced by at least 50% during the first stage compared with that at baseline. Outcome measures included episodes of fecal incontinence and number of evacuations per week, as well as the Wexner score and the Short Form 36 (SF-36) Health Survey questionnaire. RESULTS: Twenty-three SCIPs were submitted to definitive SNM, maintaining their clinical benefits after permanent implantation with a median follow-up of 38 months. The length of time since neurological diagnosis to SNM therapy represents the only factor related to the success of the implantation, P<0.05. In subjects with constipation (12), the median number of evacuations shifted from 1.65 to 4.98 per week, whereas the Wexner score changed from 19.91 to 6.82 in the final checkup with P<0.05. In subjects with fecal incontinence (11), the median number of episodes per week in the final follow-up was 1.32 compared with 4.55 pre-SNM. The general and mental health of both groups was measured with the SF-36 questionnaire and consistently showed statistical improvement (P<0.05).Anorectal manometry showed no important variation compared with baseline. There were no major complications. CONCLUSIONS: SNM therapy should be considered for the treatment of NBS for select patients with incomplete spinal cord injury when conservative treatments fail.

Sexual rehabilitation in women with spinal cord injury: a critical review of the literature.

STUDY DESIGN: Review article. OBJECTIVES: Critical review of literature on the multiple aspects of sexual rehabilitation in women with spinal cord injury (SCI) from initial recovery to long-term follow-up. SETTING: Neuro-urology Department. METHODS: Studies on sexuality selected from PubMed from 1993 to 2009. RESULTS: Literature supported by significant statistical analyses reports that females with complete tetraglegia deserved special attention immediately at initial recovery; sexual intercourse is much more difficult for them (as compared with other women with SCI) mainly because of autonomic dysreflexia and urinary incontinence. There are sparse data on predictable factors favoring sexual rehabilitation such as the age SCI was incurred, the importance of one's sexual orientation, and the SCI etiology. Information after initial discharge is based chiefly on questionnaires, which report that as more time passes since the injury, patients attain more sexual satisfaction compared with recently injured women. Studies on neurological changes after SCI, and their effect on sexual response, are supported by a significant statistical analysis, but with few SCI patients. One topic reported the effect of sildenafil on sexuality, without benefit. No paper offers any detailed analysis on the sexual impact of medical and psychological treatments related to SCI. Literature reports that some co-morbidities are more prevalent in women with SCI compared with able-bodied women but data on sexual functioning are missing. CONCLUSION: To improve sexual rehabilitation services, sexual issues and response require evaluation during periodical check-ups using validated questionnaires administered by a physician 'guide' who coordinates professional operators thus providing personalized programmable interventions.

A multicenter, double-blind, randomized, parallel group study comparing polyvinyl chloride and polyvinyl chloride-free catheter materials.

PURPOSE: In this study we compared a polyvinyl chloride catheter with a new polyvinyl chloride-free catheter with the same hydrophilic coating, and determined whether patient perception of ease and comfort of clean intermittent catheterization was independent of the catheter material. MATERIALS AND METHODS: This investigation was designed as a randomized, double-blind, parallel group, multicenter study. Eligible patients were experienced users of clean intermittent catheterization with a polyvinyl chloride catheter for a minimum of 1 month before randomization. They were randomized to continue to use the polyvinyl chloride catheter or switch to a polyvinyl chloride-free catheter for 4 weeks. Both catheters had a similar appearance. Patient perception of ease and comfort of clean intermittent catheterization was scored with questionnaires, and adverse events were documented. RESULTS: A total of 195 patients were recruited from 6 countries and 13 centers for the intent to treat analysis, and 179 were used for the per protocol analysis. Before randomization 94% to 98% of the patients rated the polyvinyl chloride catheter as easy or manageable to handle during different phases of clean intermittent catheterization and overall 92% of patients were satisfied. Of the eligible patients satisfaction was reported by 89% randomized to continue using the polyvinyl chloride catheter and by 78% randomized to switch to the polyvinyl chloride-free catheter (not significant). The rate of adverse events was low and comparable between the 2 groups. CONCLUSIONS: The study confirms that clean intermittent catheterization is easy and safe. Conversion from a polyvinyl chloride to a polyvinyl chloride-free core catheter material does not alter patient perception of catheterization.

Clinical outcome of sacral neuromodulation in incomplete spinal cord injured patients suffering from neurogenic lower urinary tract symptoms.

OBJECTIVE: To determine the efficacy and safety of sacral neuromodulation (SNM) in incomplete spinal cord injured (SCI) subjects affected by neurogenic lower urinary tract symptoms (NLUTS). METHODS: Twenty-four SCI patients were enrolled. The individuals were divided into two groups: 13 individuals in the urinary retention category and 11 suffering from overactive bladder syndrome. All subjects underwent definitive SNM implantation (Medtronic, Inc.). Voiding symptoms were assessed using patient bladder diaries, which recorded both pre-SNM and before each follow-up (1, 3 and 6 months, and then every 6 months). Outcome measures were per 24 h: number of voids and voided volume per void for both groups; number of urinary leakages, pad use and nocturia for patients with overactive bladder syndrome; and volume per catheterization and number of catheterizations for urinary retention subjects only. Final checkups were completed by June 2008. RESULTS: Median follow-up was 61 months. Up to the final visit, all subjects maintained a clinical improvement of more than 50% compared with baseline. Twenty-two side effects were recorded. Four subjects with urinary retention needed a new implant in the controlateral S3 sacral root because of loss of efficacy. One patient with urinary retention developed a wound infection at the implanted pulse generator site. CONCLUSIONS: Our study contains the largest series of implanted SCI patients ever published. SNM is a therapy to consider in the treatment of NLUTS for partial SCI patients, even if the loss of clinical benefits for patients with retentive NLUTS must be taken into account. All adverse events were treated effectively.