[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.

A prospective randomized trial comparing the 1-stage with the 2-stage implantation of a pulse generator in patients with pelvic floor dysfunction selected for sacral nerve stimulation.

OBJECTIVE: The aim of this study was to evaluate in a prospective, randomized setting if the 2-stage implant, compared to a 1-stage implant, leads to a superior subjective or objective outcome of sacral nerve stimulation after implantation of the pulse generator in patients with lower urinary tract symptoms. PATIENTS AND METHODS: We implanted a sacral (S3) foramen lead and a pulse generator (model 3023, Medtronic Inc, Minneapolis, MN, USA) in 42 patients. They were randomized in a 1-stage or a 2-stage implant if a more than 50% improvement in voided volume or reduction of residual urine was seen during the test stimulation phase as compared to baseline. RESULTS: At 24 months follow-up, subjective (visual analogue scale) and objective (voided volume or residual urine) assessment were significantly better in the 2-stage group. Ten patients (24%) failed therapy, 7 in the 1-stage implant and 3 in the 2-stage group. Two patients were lost to follow-up. Logistic regression analysis revealed that failure was positively related to the 1-stage implant and negatively to the age of the patients. 76% of the treated patients had sustained clinical benefit with 23 revisions performed. The mean cost is respectively for the PNE (2006 Euro), for the 2-stage implant (10826 Euro) and for the 1 stage implant (8505 Euro). CONCLUSION: With this study, we demonstrated that the 2-stage implantation technique of the sacral neuromodulation therapy performed as a longer test stimulation phase has a higher success rate.

Urinary retention after hysterectomy for benign disease: extended diagnostic evaluation and treatment with sacral nerve stimulation.

OBJECTIVE: To detect prospectively neurogenic damage in patients with urinary retention responding to sacral nerve stimulation (SNS) after hysterectomy for benign disease. PATIENTS AND METHODS: From August 1995 to February 2002, 13 of 15 patients (mean age 43 years, sd 7) with urine retention for a mean (sd, range) of 25 (22, 6-240) months after hysterectomy for benign disease, were prospectively evaluated and treated with SNS. They were assessed using urodynamics at baseline and during the test stimulation. Sensory evoked potentials (SEPs), electrical sensory threshold (EST) measurements of the pudendal nerve, bladder neck and the bladder (2 Hz, 0-300 V), and needle electromyography of the external urethral sphincter (EUS) were undertaken in all patients. RESULTS: De-afferentiation (EST >/= 200 V) was limited to the bladder in four of the 13 patients and extended to the bladder neck in one other, and was matched by no response at the SEP. Relative ESTs of the bladder neck correlated inversely with residual urine (r = - 0.76, P = 0.01, x = 546, fx = 1.22) and bladder capacity (r = - 0.77, P = 0.01, x = 611, fx = 1.26) at diagnosis. Complex repetitive discharges and decelerating bursts of the EUS were seen in these five patients. Unilateral SNS was applied in 10 patients (bilateral in three). A revision was needed in six patients. Uroflowmetry at the last follow-up showed a mean (sd) maximum urinary flow rate of 22 (18) mL/s (not significantly different from during trial stimulation) with residual urine of 50-100 mL in two and 200-400 mL in three patients. Intermittent catheterization was needed in four patients. CONCLUSION: Urinary retention after hysterectomy for benign disease is associated with de-afferentiation of the bladder wall in some patients and is correlated inversely with the relative EST of the bladder neck. A Fowler syndrome was detected in five patients. For residual urine, about half the patients have a good and a third a partial long-term effect; we now offer SNS as a further treatment option.

A high easy-to-treat complication rate is the price for a continent stoma.

OBJECTIVE: To evaluate the conduit-related complications and their treatment in Mitrofanoff continent urinary diversion and antegrade colonic enema (ACE) procedures. PATIENTS AND METHODS: The files of 53 patients (18 men and 35 women) in whom 58 continent stomas were created were retrospectively reviewed. Gender, age, age at the time of surgery, underlying disease, concomitant surgery, abdominal position of the stoma, follow-up, complications and treatment were assessed. The mean (sd) age at the time of surgery was 19 (13) years; 30 patients were aged <15 years and the mean follow-up was 2.8 (1.9) years. Fifty-three continent vesicostomy-type Mitrofanoff stomas were constructed and five ACE procedures performed. Forty-five stomas were in the umbilicus and 13 on the abdominal wall. For 45 conduits the appendix was used; in the other 13 a transverse tubularized ileal segment according to Monti was created. RESULTS: There were stoma-related complications in 19 patients (36%), with 27 in all and stomal stenosis accounting for more than half. Five patients had urinary leakage. The median time to the first complication was 9 months. Multiple regression analysis showed that gender and stoma location were the only significant determinants of the complication/follow-up ratio. Women had more complications than men and umbilical stomas fared worse than those on the abdominal wall. Age, underlying disease and type of stoma were not significantly related to the complication/follow-up ratio. The complication was treated by one procedure in 13 patients; four needed two and two needed three surgical revisions. Most complications were relatively easy to treat, i.e. dilatation in five, endoscopic incision in one, re-anastomosis in four, Y-V plasty in seven, a new channel in two, reimplantation in three, a bladder cuff in two for stomal leakage, and abdominoplasty in two. Only one stoma had to be abandoned. CONCLUSION: The complication rate for continent small-diameter stoma is high. However, most complications are relatively easy to treat. Despite these complications, patient satisfaction remains high.

Transcutaneous neuromodulation for the urge syndrome in children: a pilot study.

PURPOSE: Neuromodulation has been used to treat voiding dysfunction in adults. Due to its invasiveness it has rarely been used in children until now with the availability of transcutaneous neurostimulation. We evaluated clinical effects of transcutaneous neuromodulation on detrusor overactivity in children with the urge syndrome. MATERIALS AND METHODS: Between May 1, 1998 and February 28, 1999, 15 girls (mean age 10.2 years) and 26 boys (mean age 10.7 years) with proved detrusor hyperactivity on videourodynamic study underwent neuromodulation. All children had been given anticholinergic therapy previously. Neurostimulation only was used in children in whom anticholinergics had no effect and those who had significant side effects. Anticholinergics were continued in children in whom they had a partial effect. Stimulation of 2 Hz. was applied for 2 hours every day. Surface electrodes were placed at the level of sacral root S3. After 1 month of trial stimulation those children who responded continued the treatment for 6 months, and were evaluated every 2 months. RESULTS: Of the 41 children 15 boys and 13 girls responded after 1 month of trial therapy with an increase in bladder capacity, decrease in urgency, decrease in incontinence and/or better sensitivity. Of the 13 children who did not respond 9 lacked motivation and 4 had no clinical effect despite motivation. After 6 months of therapy a significant increase in bladder capacity, decrease in voiding frequency and decrease in incontinence periods were noted. Adverse effects were not observed. One year after therapy relapse was noted in 7 patients, leaving 21 of 41 children definitively cured. CONCLUSIONS: Although preliminary, our results indicate that transcutaneous neuromodulation can improve symptoms of detrusor overactivity, as response to stimulation was noted in 76% of our patients and 56% were cured after 1 year. This therapeutic option is attractive for children because of its noninvasiveness and absence of adverse effects.

The pain cycle: implications for the diagnosis and treatment of pelvic pain syndromes.

The aim of the study was to report our results of sacral nerve stimulation in patients with pelvic pain after failed conservative treatment. From 1992 to August 1998 we treated 111 patients (40 males, 71 females, ages 46 +/- 16 years) with chronic pelvic pain. All patients with causal treatment were excluded from this study. Pelvic floor training, transcutaneous electrical nerve stimulation (TENS) and intrarectal or intravaginal electrostimulation were applied and sacral nerve stimulation was used for therapy-resistant pain. The outcome of conservative treatment and sacral nerve stimulation (VAS <3/10; >50% pain relief) was related to symptoms of voiding dysfunction and dyschezia, and urodynamic proof of dysfunctional voiding, not to the pain localization or treatment modality. Outcome was inversely related to neuropathic pain. When conservative treatment failed, a test stimulation of the S3 root was effective in 16/26 patients, and 11 patients were implanted successfully with a follow-up of 36 +/- 8 months. So far no late failures have been seen. A longer test stimulation is needed in patients with pelvic pain because of a higher incidence of initial false positive tests. Our conclusion is that sacral nerve stimulation is effective in the treatment of therapy-resistant pelvic pain syndromes linked to pelvic floor dysfunction.

Patient satisfaction and complications following sacral nerve stimulation for urinary retention, urge incontinence and perineal pain: a multicenter evaluation.

The aim of the study was to determine the success rate, the complications, the failures and the solutions found in troublesome cases. A retrospective study was performed in three university centers in Belgium. Between March 1994 and April 1998, a quadripolar electrode and a pulse generator were implanted in 53 patients (8 men, 45 women, 43 +/- 12 years, mean follow-up 24 +/- 8 months, range 13-39 months). During the first few months, 45 (85%) of the 53 patients had an objective response. Eight late failures occurred, with a mean failure delay of 9 +/- 5 months. We performed 15 revisions in 12 patients. Major complications were pain and current-related troubles. The outcome was significantly better (P = 0.001) in post-stress incontinence surgery patients. Device-related pain was found more frequently in patients with dysuria and/or retention or perineal pain, and the test stimulation was less reliable (P = 0.025) in patients with a psychiatric history. Sacral nerve stimulation is efficient in treating patients with refractory lower urinary tract symptoms and/or perineal pain.

Bilateral S3 nerve stimulation, a minimally invasive alternative treatment for postoperative stress incontinence after implantation of an anterior root stimulator with posterior rhizotomy: a preliminary observation.

STUDY DESIGN: A preliminary report. OBJECTIVES: Urinary stress incontinence following implantation of an anterior root stimulator and a posterior rhizotomy is a rare complication which is difficult to treat. It is seen in patients with an open bladder neck (T9-L2 lesion). An artificial urinary sphincter is a possible treatment for this condition but has a higher failure rate in patients with neurogenic bladder disease and could complicate micturition. SETTING: Ghent, Belgium. METHODS: A male paraplegic patient (T9, complete lesion) aged 36 was suffering from severe urinary incontinence due to detrusor hyperreflexia. Preoperatively the bladder neck was closed on cystography. Following implantation (6/95) of an intradural anterior root stimulator with posterior rhizotomy, severe urinary stress incontinence presented. Bilateral S3 foramen leads were implanted and connected to a pulse generator. RESULTS: The patient has been continent with continuous stimulation of both S3 roots for 4 years, and no fatigue of the levator muscles has been seen. Preoperative urodynamics are compared to results 3 years postoperatively. CONCLUSION: Bilateral S3 stimulation is a feasible and minimally invasive treatment of urinary stress incontinence following implantation of an anterior root stimulator.

The urodynamic evaluation of neuromodulation in patients with voiding dysfunction.

OBJECTIVES: To determine which patients with voiding dysfunction might be suitable for treatment with neuromodulation, using urodynamics to obtain an objective measure of improvement and to illustrate the effect of neuromodulation on voiding dysfunction. PATIENTS AND METHODS: Patients were selected for implantation of a neuroprosthesis using a urodynamic evaluation before and during subchronic stimulation; 27 such patients (four men and 23 women, mean age 33 years, SD 15) were evaluated. RESULTS: Of the 27 patients, the 17 who responded well to neuromodulation all had hypocontractile detrusors and sphincter hypertonicity; sphincter relaxation during micturition was impaired. The urodynamic evaluation showed that these patients were not obstructed. Of 10 patients with spastic pelvic floor syndrome, nine responded well to the treatment. Those not responding to neuromodulation had mainly acontractile detrusors. CONCLUSION: The ideal candidates for neuromodulation are those patients with a spastic pelvic floor syndrome or with a hypocontractile detrusor, in combination with sphincter instability, and impaired sphincter relaxation. An increase of bladder contractility, enhancement of sphincter relaxation and decrease in bladder capacity and residual urine are the most important features of the response.