Predictors of Success with Neuromodulation in Lower Urinary Tract Dysfunction: Results of Trial Stimulation in 100 Patients (original) (raw)
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BMC Urology, 2014
Background: Sacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials. Methods and design: This study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation. Discussion: It is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction.
Sacral neuromodulation for lower urinary tract dysfunction
World Journal of Urology, 2011
Objectives To review the technique, indications, results and working mechanisms of sacral neuromodulation (SNM) for lower urinary tract dysfunction. Methods The available literature on SNM for lower urinary tract dysfunction was searched. Based on the information available in the literature and also based on personal experience, the urological indications, technique, mechanisms of action and results of SNM are presented and discussed. Results SNM for lower urinary tract dysfunction involves stimulation of the 3rd sacral nerve with an electrode implanted in the sacral foramen and connected to a pulse generator. The technique is accepted by the FDA since 1997. Currently, SNM for lower urinary tract dysfunction has been successfully used in about 26,000 patients with various forms of lower urinary tract dysfunction, including urgency, frequency and urgency incontinence as well as non-obstructive urinary retention. The actual procedure of SNM consists of a minimal invasive technique and is effective in about 70% of the patients who have been implanted with a permanent system. Also, in pelvic pain, interesting results have been described. SNM modulates the micturition reflexes at different levels in the central nervous system. Conclusions Sacral neuromodulation is a safe and effective therapy for various forms of lower urinary tract dysfunction, including urgency, frequency and urgency incontinence as well as non-obstructive urinary retention. It should be the first choice after failure of maximal conservative therapy.
Sacral Nerve Stimulation for Neuromodulation of the Lower Urinary Tract
Springer eBooks, 2009
Patients with symptoms of overactive bladder syndrome or non-obstructive urinary retention, refractory to conservative therapy, can nowadays be treated minimally invasively with sacral nerve stimulation (SNS). The use of electric currents to treat urological pathology has a long history but SNS therapy only received FDA approval in 1997. The mechanisms of action are still not known so there are different theories explaining the modulation effect. Recent studies have shown a central modulation effect. Predictive factors which can help to identify the perfect candidates are not known. Over the years the technique of SNS has become less invasive and because of two stage implantation test results have proven to be more reliable. The clinical results for this therapy have proven to be safe and effective and with the technical improvements over the years the re-operation and complication rates have decreased significantly. The clinical results have led to expanding indications because of positive effects in other symptoms. In the field of urology this has resulted in the use of SNS therapy for interstitial cystitis, neurogenic lower urinary dysfunction, and pediatric voiding dysfunction. In the field of gastro-intestinal pathology, SNS therapy is used to treat faecal incontinence and constipation.
International braz j urol : official journal of the Brazilian Society of Urology
We report on the short-term outcomes of sacral neuromodulation (SNM) for treatment of idiopathic lower urinary tract dysfunction in Brazil (procedures performed before 2014). Clinical data and surgical outcomes of patients who underwent SNM staged procedures were retrospective evaluated. Urological assessment included a focused medical history and physical examination, measurement of postvoid residual volumes, urodynamics, and bladder diaries. A successful test phase has been defined by improvement of at least 50% of the symptoms, based on bladder diaries. From January 2011 to December 2013, eighteen consecutive patients underwent test phase for SNM due to refractory overactive bladder (15 patients), non-obstructive chronic urinary retention (2 patients), and bladder pain syndrome/interstitial cystitis (1 patient). All patients underwent staged procedures at four outpatient surgical centers. Mean age was 48.3±21.2 (range 10-84 years). There were 16 women and 2 men. Median follow-up ...
Neuromodulation for Lower Urinary Tract Dysfunction – An Update
TSW Urology, 2007
The aim of this review is to provide an update on the use of neuromodulation using sacral nerve stimulation for the treatment of disorders of the lower urinary tract. Neuromodulation using the InterStim® system (Medtronic Inc.) is now accepted as an established therapeutic option for patients with detrusor overactivity, and for women with retention or severe voiding difficulties. However, the use of nerve stimulation in modulating lower urinary tract function has to be regarded as a technique that is in its infancy.
Italian Journal of Gynaecology and Obstetrics
Objective. Sacral neuromodulation (SNM) is a technique that electrically stimulates the third sacral spinal nerve root to modulate a neural pathway. In this study, we present our 7-years' experience outcomes and complications of SNM in lower urinary tract dysfunctions. Materials and Methods. We performed a single-center retrospective cohort study of all patients who underwent InterStim Medtronic SNM device implantation for lower urinary tract dysfunction. All procedures were performed between January 2014 and November 2021 in the Urogynecologycal Center of Villa Sofia Hospital in Palermo by a single expert team. We included 68 patients with refractory lower urinary tract dysfunction who did not adequately respond to primary therapeutical strategies. Results. We observed a reduction rate of catheterization from a mean of 4.05 to 1.22. In addition, the amount of post-voidal residual decreased from a mean of 520 ml to 187 ml. Among the 41 women in the overactive bladder group, only 36 were included in the follow-up; 24 of the 36 patients (66.6%) had no episodes of leaks; the remaining patients (33.4%) had a significant reduction of leaks. We also recorded a significant reduction in urinary frequency: voids per day decreased from 16.1 at baseline to 6.1. Among the 7 women with BPS, only 5 patients (71.42%) completed the follow-up protocol. They reported satisfaction from the treatment: no patients chronically used pain drugs, and only 1 used occasionally painkillers. Conclusions. SNM treatment has been found as a potential effective and feasible option for urogynecologycal disorders.
Siriraj Medical Journal
Objective: To demonstrate which types of non-neurogenic female lower urinary tract dysfunction (LUTD) respond to sacral neuromodulation (SNM) after the failure of all non-invasive treatments.Materials and Methods: Female LUTD performed SNM between 2017 and 2019 were retrospectively reviewed. A case with anatomical or neurological abnormalities were excluded by thorough physical examination and investigations. The specific type of LUTD, including midurethral obstruction (MUO), was diagnosed by videourodynamics (VUDS). Clinical diagnoses, including idiopathic urinary retention (IUR), voiding dysfunction (VD) and refractory overactive bladder (OAB), were used instead of VUDS diagnosis when the result was normal or inconclusive. The International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS) in Thai version were used to compare between pre and post-treatment. Responder was defined as an IPSS and/or OABSS decreased more than 50% from baseline.Results: Total 2...
The Journal of Urology, 2011
Purpose: Few reports address the reoperation rate after sacral neuromodulation implants. We report our long-term results and reoperations during our 14-year experience with sacral neuromodulation at our center. Materials and Methods: We retrospectively reviewed the patient database at our center to assess the long-term outcome, incidence and cause of surgical reintervention after InterStim® sacral neuromodulation implantation for lower urinary tract dysfunction between 1994 and 2008. Results: A total of 96 sacral neuromodulation devices were implanted in 88 women and 8 men. Indications for implantation were bladder pain syndrome in 47.9% of cases, urgency urinary incontinence in 35.4% and idiopathic urinary retention in 16.7%. The explantation rate was 20.8% and median time to removal was 18.5 months. Reasons for explantation in all subgroups were poor result in 12 patients, painful stimulation in 6 and radiation of stimulation to the leg in 2. Median long-term followup was 50.7 months. The longterm success rate was 87.5%, 84.8% and 73% in patients with idiopathic urinary retention, urgency urinary incontinence and bladder pain syndrome, respectively. Overall 39% of patients needed revision of the sacral neuromodulation implant. The main reason for revision was loss of stimulation in 58.5% of cases. The revision rate decreased with the introduction of the tined lead technique from 50% using lead Model 3092 to 31% using lead Model 3893 (Medtronic, Minneapolis, Minnesota). The battery was changed in 8 patients. Mean battery life was 101.8 months. Conclusions: Sacral neuromodulation is a minimally invasive procedure with a good long-term outcome. The reoperation rate has improved with advances in surgical technique and equipment. Abbreviations and Acronyms BPS ϭ bladder pain syndrome FDA ϭ Food and Drug Administration GRA ϭ global response assessment scale IPG ϭ implanted pulse generator IUR ϭ idiopathic urinary retention PNE ϭ percutaneous nerve evaluation SNM ϭ sacral neuromodulation UUI ϭ urgency urinary incontinence