Jerzy B. Gajewski

Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention☆

Many patients have chronic, debilitating symptoms of voiding dysfunction that are refractory to conventional medical or surgical therapies. This multicenter, prospective study evaluated the long-term effectiveness of sacral nerve stimulation using the implantable Medtronic InterStim therapy for urinary control in patients with otherwise intractable complaints of urinary urge incontinence, urgency-frequency, or retention. Each patient first underwent temporary, percutaneous sacral nerve test stimulation. If at least a 50% reduction in target symptoms was documented for at least 3 days, patients received a permanent Medtronic InterStim sacral nerve stimulation system that includes a surgically implanted lead and neurostimulator. Regular follow-up was conducted with outcome data. We report here on patients who have been observed from 1.5 to 3 years postimplantation. The results demonstrate that after 3 years, 59% of 41 urinary urge incontinent patients showed greater than 50% reduction in leaking episodes per day with 46% of patients being completely dry. After 2 years, 56% of the urgency-frequency patients showed greater than 50% reduction in voids per day. After 1. 5 years, 70% of 42 retention patients showed greater than 50% reduction in catheter volume per catheterization. We conclude that the Medtronic InterStim therapy for urinary control system is an effective therapy with sustained clinical benefit for patients with intractable symptoms of urinary urge incontinence, urgency-frequency, or retention.

Long–Term Effectiveness of Sacral Nerve Stimulation for Refractory Urge Incontinence

Objectives: To evaluate the long–term efficacy of sacral nerve stimulation for refractory urinary urge incontinence. Study Design and Methods: Urge incontinent patients qualified for surgical implantation of a neurostimulator system after trial screening with percutaneous test stimulation. Surgical implantation of the InterStim System (Medtronic Inc., Minneapolis, Minn., USA) was performed in cases where a >50% reduction in incontinence symptoms was documented during the 3– to 7–day test stimulation period. The InterStim System consists of an implantable pulse generator, a transforamenally placed quadripolar lead, and an extension that connects these two devices for unilateral stimulation of the S3 or S4 sacral nerve. Efficacy for 96 implanted patients was based on urinary symptom changes as quantified in voiding diaries collected at baseline and annually after surgical implantation. Results: As compared to baseline, the group of 96 implanted patients demonstrated significant reductions in urge incontinent symptoms at an average of 30.8±14.8 (range 12–60) months with respect to the number of urge incontinent episodes per day, severity of leaking, and the number of absorbent pads/diapers replaced per day due to incontinence (all p<0.0001, respectively). Gender, pretreatment variables, and age were not found to be relevant factors that affected these results. 11 of the 96 patients underwent device explant due to lack of efficacy, pain or bowel dysfunction. These data were conservatively included in the efficacy results. No permanent injuries associated with the devices or therapy were reported. Conclusion: Sacral nerve stimulation is an effective treatment for refractory urge incontinence with sustained long–term benefit through an average of 30.8 months.

Oxybutynin Versus Propantheline in Patients with Multiple Sclerosis and Detrusor Hyperreflexia

Hyperreflexia is the most common urological finding in patients with multiple sclerosis. A prospective randomized study was done to compare the effectiveness of 2 commonly used drugs, oxybutynin and propantheline. Of the 34 patients entered into the trial 19 were treated with oxybutynin and 15 with propantheline. The urological symptoms (frequency, nocturia, hesitancy, urgency and urge incontinence) were graded according to severity from 0 to 3. Patients with urinary infection were excluded. Urodynamic examination, consisting of cystometrography and electromyography, was performed in all patients before treatment. Both groups of patients had comparable neurological, urological and urodynamic status before treatment. In 4 patients (21 per cent) treated with oxybutynin and in 4 (27 per cent) treated with propantheline side effects were so severe that the treatment had to be discontinued. Symptomatic response to oxybutynin was good in 10 patients (67 per cent), fair in 2 (13 per cent) and poor in 3 (20 per cent). Propantheline produced good symptomatic results in 4 patients (36 per cent), fair in 1 (9 per cent) and poor in 6 (55 per cent). The mean increase in maximum cystometric capacity on cystometrography was significantly larger in the oxybutynin group than in the propantheline group (144 +/- 115 versus 35 +/- 101). Our results indicate that oxybutynin is more effective than propantheline in the treatment of detrusor hyperreflexia in patients with multiple sclerosis.

Efficacy of Botulinum Toxin A Injection for Neurogenic Detrusor Overactivity and Urinary Incontinence: A Randomized, Double-Blind Trial

PURPOSE We determined the efficacy of onabotulinumtoxinA for neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis. MATERIALS AND METHODS In a prospective, double-blind, multicenter study 57 patients 18 to 75 years old with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis and urinary incontinence (defined as 1 or more occurrences daily) despite current antimuscarinic treatment were randomized to onabotulinumtoxinA 300 U (28) or placebo (29) via cystoscopic injection at 30 intradetrusor sites, sparing the trigone. Patients were offered open label onabotulinumtoxinA 300 U at week 36 and followed a further 6 months while 24 each in the treatment and placebo groups received open label therapy. The primary efficacy parameter was daily urinary incontinence frequency on 3-day voiding diary at week 6. Secondary parameters were changes in the International Consultation on Incontinence Questionnaire and the urinary incontinence quality of life scale at week 6. Diary and quality of life evaluations were also done after open label treatment. RESULTS The mean daily frequency of urinary incontinence episodes was significantly lower for onabotulinumtoxinA than for placebo at week 6 (1.31 vs 4.76, p <0.0001), and for weeks 24 and 36. Improved urodynamic and quality of life parameters for treatment vs placebo were evident at week 6 and persisted to weeks 24 to 36. The most common adverse event in each group was urinary tract infection. CONCLUSIONS In adults with antimuscarinic refractory neurogenic detrusor overactivity and multiple sclerosis onabotulinumtoxinA is well tolerated and provides clinically beneficial improvement for up to 9 months.

Relationship between neurological and urological status in patients with multiple sclerosis.

The relationship between neurological urinary symptoms and urodynamic findings in patients with multiple sclerosis was examined. The duration of multiple sclerosis was significantly longer in patients with urinary symptoms. The presence of urinary symptoms correlated with the severity of the pyramidal or sensory lesions and the total disability score. Cystometrograms revealed detrusor hyperreflexia in 67 per cent of the patients, areflexia in 21 per cent and a normal detrusor in 12 per cent. Somatic dyssynergia was found in 20 of the 39 patients whose examination revealed clear-cut results. Positive correlation was found between urge incontinence and detrusor hyperreflexia, and between hesitancy and detrusor areflexia but no relationship was found between urological symptoms and sphincter function. Analysis of the neurological lesions in relation to the cystometric findings revealed a positive correlation among pyramidal lesions, detrusor hyperreflexia and detrusor areflexia, and between cerebellar lesions and detrusor areflexia. The correlation between detrusor dysfunction and high total disability score disappeared when patients with high pyramidal scores were excluded. No correlation could be detected between somatic dyssynergia and the various neurological lesions.

Experimental evidence for a central nervous system site of action in the effect of alpha-adrenergic blockers on the external urinary sphincter

The present study was done to test the hypothesis that alpha-adrenoceptor blocking drugs (phentolamine and prazosin) could interfere with somatic control of the external sphincter through an action in the central nervous system. Stimulation of the hypogastric nerve in the chloralose-anesthetized cat caused a urethral constriction which could be antagonized by alpha-receptor blockers. However, the constriction produced by stimulation of the S1 or S2 ventral root was completely resistant to alpha blockade. The drugs therefore had the expected action against sympathetic stimulation of the urethra but had no peripheral effect on the somatic component. The central effect of these drugs was investigated by recording urethral perfusion pressure responses, or compound action potentials on the central cut end of the pudendal nerve, evoked by stimulation of the contralateral pudendal or pelvic nerve. The urethral constriction produced by stimulation of the central cut end of 1 pudendal nerve was antagonized by both prazosin and phentolamine. Action potentials evoked on the pudendal nerve by stimulation of the central cut end of the contralateral pudendal or pelvic nerve were substantially inhibited by prazosin. Phentolamine produced a more variable blockade of the pudendal-pudendal reflex. The results strongly indicate that these alpha-adrenoceptor antagonists and especially prazosin can influence pudendal nerve-dependent urethral responses through a central nervous system action and not through a peripheral mechanism.

LONG-TERM FOLLOWUP OF THE NORTH AMERICAN MULTICENTER UROLUME* TRIAL FOR THE TREATMENT OF EXTERNAL DETRUSOR-SPHINCTER DYSSYNERGIA

PURPOSE We determine the long-term efficacy and safety of the UroLume stent as minimally invasive treatment for external detrusor-sphincter dyssynergia in spinal cord injured men. MATERIALS AND METHODS A total of 160 spinal cord injured men with a mean age plus or minus standard deviation of 36.3 +/- 12.1 years (range 16 to 74) were prospectively treated with an endoprosthesis at 15 centers as part of the North American UroLume trial for external detrusor-sphincter dyssynergia. Urodynamic parameters, including voiding pressure, residual urine volume and bladder capacity, were compared before treatment and at 1, 2, 3, 4 and 5 years after treatment. RESULTS Mean voiding pressure was 75.1 +/- 28.2 cm. water before treatment in the 160 patients, and 37.4 +/- 23.9 at year 1 in 97, 39.5 +/- 22.2 at year 2 in 84, 42.6 +/- 27.3 at year 3 in 61, 46.3 +/- 33.2 at year 4 in 57 and 44.2 +/- 28.9 cm. at year 5 in 41 after stent insertion (p <0.001). Residual urine volume decreased after stent placement and was maintained throughout the 5-year followup (p <0.001). Mean cystometric capacity remained constant from 269 +/- 155 before insertion to 337 +/- 182 ml. 5 years later (p = 0.17). Hydronephrosis and autonomic dysreflexia improved or stabilized in most patients with functioning stents. Stent explant was necessary in 24 patients (15%), of whom 4 (16.7%) had another stent implanted. CONCLUSIONS The UroLume stent demonstrates long-term safety and efficacy for the treatment of external detrusor-sphincter dyssynergia. The outcome was similar in men with and without previous sphincterotomy.

Long-Term Outcome and Surgical Interventions After Sacral Neuromodulation Implant for Lower Urinary Tract Symptoms: 14-Year Experience at 1 Center

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 re-intervention 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 long-term 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.

The long-term efficacy of sacral neuromodulation in the management of intractable cases of bladder pain syndrome: 14 years of experience in one centre

Study Type – Therapy (case series)
Level of Evidence 4

2012 Update: Guidelines for Adult Urinary Incontinence Collaborative Consensus Document for the Canadian Urological Association

Adult urinary incontinence (UI) is a highly prevalentcondition, and one which can have a major impacton patients’ quality of life. It is also a major focus ofa urologist’s workload. As a result, the Canadian UrologicalAssociation (CUA), with the aid of its Guidelines Committee,commissioned the development of a practice guideline documentin 2005 first authored by Dr. Jacques Corcos. As perthe CUA Guidelines Committee’s mandate, all guidelinesare subject to revision after 5 years.