Gracilis urethromyoplasty--an autologous urinary sphincter for neurologically impaired patients with stress incontinence.

PURPOSE: To investigate the effect of a neurovascularly intact gracilis muscle urethral wrap, to be used to restore urinary continence as a transposed urinary sphincter graft, in patients with neurogenic lower urinary tract dysfunction. METHODS: Five neurologically impaired men with a denervated and damaged urinary sphincter mechanisms were treated. The etiology of sphincteric insufficiency included sphincter denervation in three patients, external sphincterotomy in one, and urethral trauma due to a chronic indwelling catheter in one. All patients underwent gracilis urethromyoplasty sphincter reconstruction. Two patients also underwent concomitant ileocystoplasty and one patient ileocystostomy because of poor bladder compliance and a bladder capacity of < 200 ml. RESULTS: The gracilis urethromyoplasty functioned as a new autologous sphincter with follow-ups ranging from 6-35 months. The surgery was successful in four patients. Three of the four patients were managed with intermittent catheterization, and one managed by ileocystostomy. The fifth patient continued to require an indwelling urethral catheter. CONCLUSION: Gracilis urethromyoplasty achieves compression of the urethra using a neurovascularly intact muscle graft. The functional urethral closure, obtained from the gracilis muscle wrap, assures dryness, and permits intermittent self-catheterization. It also avoids the risks of infection, erosion, or malfunction associated with the artificial urinary sphincter. The potential exists for electrical stimulation of this muscle graft to allow volitional control of the neo-sphincter mechanism, and voluntary voiding.

Sphincteric stent versus external sphincterotomy in spinal cord injured men: prospective randomized multicenter trial.

PURPOSE: In a prospective randomized multicenter trial we compared the treatment results of conventional external sphincterotomy with those of UroLume sphincteric stent prosthesis placement in men with spinal cord injury and external detrusor-sphincter dyssynergia. MATERIALS AND METHODS: We randomized 57 men with spinal cord injury in whom urodynamics verified external detrusor-sphincter dyssynergia into 2 groups to undergo either sphincter defeating procedure. We compared the primary urodynamic parameter of maximum detrusor pressure, and secondary urodynamic parameters of bladder capacity and post-void residual urine volume in men who underwent sphincterotomy or sphincteric stent placement. Parameters were measured preoperatively, and 3, 6, 12 and 24 months postoperatively. Patients completed questionnaires regarding voiding sensation and quality of life issues at each followup visit. RESULTS: Demographic data of the 26 patients treated with sphincterotomy and the 31 treated with sphincteric stent placement were statistically similar. Preoperatively mean maximum detrusor pressure plus or minus standard deviation in sphincterotomy and stent cases was 98.3 +/- 27.6 and 95.7 +/- 27.7 cm. water, respectively (p = 0.73). At 12 months mean maximum detrusor pressure decreased to 48.9 +/- 16.4 and 52.6 +/- 31.6 cm. water in the sphincterotomy and stent groups, respectively (p = 0). Preoperatively mean bladder capacity in sphincterotomy and stent cases was 245 +/- 158 and 251 +/- 145 ml., respectively (p = 0.87). Bladder capacity did not change significantly in either treatment group throughout followup. Preoperatively mean post-void residual urine volume in the sphincterotomy and stent groups was 212 +/- 163 and 168 +/- 114 ml., respectively (p = 0.33). Residual urine volume decreased in each group at some but not all followup evaluations. The duration of hospitalization was greater for sphincterotomy than stenting (p = 0.036). Six stents required explantation. CONCLUSIONS: The UroLume stent is as effective as conventional external sphincterotomy for treating external detrusor-sphincter dyssynergia. However, sphincteric stent placement is advantageous because it involves shorter hospitalization and is potentially reversible.

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.

Removal of UroLume endoprosthesis: experience of the North American Study Group for detrusor-sphincter dyssynergia application.

PURPOSE: We present the experience of the North American UroLume Multicenter Study Group with removal of the UroLume endoprosthesis. MATERIALS AND METHODS: A total of 160 neurologically impaired patients were enrolled in the North American UroLume Multicenter Study Group for detrusor external sphincter dyssynergia application. Analysis was performed in 2 groups of patients in which the device was removed during insertion and after implantation, respectively. RESULTS: Device retrieval was required during insertion in 21 patients (13%) mainly due to misplacement or migration in 17. Extraction was done with minimal complications and in all but 2 cases subsequent UroLume implantation was successful. Of 158 men with the device in place 31 (19.6%) required removal. In 34 procedures 44 devices were removed, mainly due to migration. Time from implantation to removal ranged from 4 days to 66 months (mean 22 months). The UroLume was removed en bloc in 20 cases and in parts or wire by wire in 19. The majority of patients had no or minimal complications after extraction. Only 2 patients had serious temporary complications, including bleeding and urethral injury, with no lasting consequences. No malignancy developed as a result of UroLume insertion. CONCLUSIONS: While there is a potential for urethral injury and bleeding, UroLume endoprosthesis removal is largely a simple procedure with minimal complications and consequences.