The role of neuromodulation in the management of urinary urge incontinence.

OBJECTIVE: To examine the benefit-risk profile of neuromodulation in treating refractory urinary urge incontinence and other voiding disorders. PATIENTS AND METHODS: The outcome measures from all patients in pivotal clinical trials who had undergone sacral nerve stimulation were analysed retrospectively. RESULTS: Neuromodulation was effective in several clinical studies; the response is durable and the benefit-risk profile good. CONCLUSION: Sacral nerve stimulation is becoming the standard of care for refractory overactive bladder and retention problems. The potential benefit of neuromodulation should be included in female urology and gynaecology training programmes.

Sacral neuromodulation and pregnancy.

PURPOSE: Sacral neuromodulation is effective for lower urinary tract dysfunction. However, despite its increasing use and a preponderance of female patients treated to our knowledge its effect in pregnant women and developing fetuses remains unknown. Therefore, we obtained information on patients on sacral neuromodulation who then achieved pregnancy. MATERIALS AND METHODS: Data were obtained using a standard questionnaire from 4 physicians with a total of 6 eligible patients. We recorded patient urological history, indication for neuromodulation, pregnancy course, the mode of delivery and neonatal health. We also noted the timing of implant deactivation and reactivation. RESULTS: In 5 patients the stimulator was deactivated between weeks 3 and 9 of gestation, after which 2 with a history of urinary retention had urinary tract infection. In another case, stimulation was discontinued 2 weeks before conception. The only noted complication developed in a pregnancy in which birth was premature at 34 weeks. Three patients underwent normal vaginal delivery, including 1 in whom subsequent implant reactivation did not resolve voiding dysfunction. In 3 cases elective cesarean section was performed. All neonates were healthy. CONCLUSIONS: When a patient on neuromodulation achieves pregnancy, the stimulation should be deactivated. If implant deactivation leads to urinary related complications that threaten the pregnancy, reactivation should be considered. Elective cesarean section should be discussed since it is possible for sacral lead damage or displacement to occur during vaginal delivery.

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.

Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation.

PURPOSE: We investigate the efficacy of sacral neurostimulation in patients with idiopathic urinary retention in a prospective, randomized multicenter trial. MATERIALS AND METHODS: A total of 177 patients with urinary retention refractory to standard therapy were enrolled in the study. Greater than 50% improvement in baseline voiding symptoms during a 3 to 7-day percutaneous test stimulation qualified a patient for surgical implantation of an InterStim parallel system. Of the patients who qualified for implantation 37 were randomly assigned to a treatment and 31 to a control group. Patients in the treatment group underwent early surgical implantation of the sacral nerve stimulation system, while implantation was delayed in the control group for 6 months. Followup evaluations, including voiding diary analysis and temporary deactivation of the stimulator at 6 months, were conducted at 1, 3, 6, 12 and 18 months after implantation in the treatment group, and after 3 and 6 months in the control group. RESULTS: Compared to the control group, patients implanted with the InterStim system had statistically and clinically significant reductions in the catheter volume per catheterization (p <0.0001). Of the patients treated with implants 69% eliminated catheterization at 6 months and an additional 14% had a 50% or greater reduction in catheter volume per catheterization. Therefore, successful results were achieved in 83% of the implant group with retention compared to 9% of the control group at 6 months. Temporary inactivation of sacral nerve stimulation therapy resulted in a significant increase in residual volumes (p <0.0001) but effectiveness of sacral nerve stimulation was sustained through 18 months after implant. CONCLUSIONS: Results of this prospective, randomized clinical study demonstrate that sacral nerve stimulation is effective for restoring voiding in patients with retention who are refractory to other forms of treatment.

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.

Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety.

PURPOSE: Neuromodulation of sacral nerves has shown promising results in correcting voiding dysfunction. We report the results of a multicenter trial designed to assess the efficacy of sacral nerve neuromodulation in patients presenting with refractory urinary urgency-frequency. MATERIALS AND METHODS: A total of 51 patients from 12 centers underwent baseline assessment, including a detailed voiding diary, urodynamic evaluation and percutaneous test stimulation of the sacral nerves at S3 and/or S4. All patients enrolled in the study had undergone prior conventional treatment, such as pharmacotherapy, hydrodistention and surgical intervention, which failed. All patients demonstrated a satisfactory response to trial stimulation and were randomly divided into a stimulation group (25 patients) and a control group (26). A sacral nerve stimulation device was implanted after 6 months in the control group. Patients were followed at 1, 3 and 6 months, and at 6-month intervals for up to 2 years after implantation of a neuroprosthetic InterStim* system. dagger The study variables included the number of voids daily, volume voided per void and degree of urgency before void. RESULTS: Compared to the control group, 6-month voiding diary results demonstrated statistically significant improvements (p <0.0001) in the stimulation group with respect to the number voids daily (16.9 +/- 9.7 to 9.3 +/- 5.1), volume per void (118 +/- 74 to 226 +/- 124 ml.) and degree of urgency (rank 2.2 +/- 0.6 to 1.6 +/- 0.9). Patients in the control group showed no significant changes in voiding parameters at 6 months. Significant improvements in favor of the stimulation group were noted in various parameters with respect to water cystometry and quality of life (SF-36). At 6 months after implant, neurostimulators were turned off in the stimulation group and urinary symptoms returned to baseline values. After reactivation of stimulation sustained efficacy was documented at 12 and 24 months. CONCLUSIONS: Neuromodulation of the sacral nerves is an effective, safe therapy that successfully treats significant symptoms of refractory urgency-frequency.

Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group.

PURPOSE: A prospective, randomized study was performed to evaluate sacral nerve stimulation for the treatment of refractory urinary urge incontinence. MATERIALS AND METHODS: Primary outcome variables were obtained from voiding diaries. After baseline evaluation candidates who satisfied inclusion criteria were enrolled into the study. Test stimulation results determined eligibility for randomization into a stimulation (treatment) or delay (control) group. The stimulation group included 34 patients who underwent implantation and were followed for 6 months. The delay group comprised 42 patients who received standard medical therapy for 6 months and then were offered implantation. The stimulation group completed a therapy evaluation test (on versus off) after 6 months. RESULTS: At 6 months the number of daily incontinence episodes, severity of episodes and absorbent pads or diapers replaced daily due to incontinence were significantly reduced in the stimulation compared to the delay group (all p<0.0001). Of the 34 stimulation group patients 16 (47%) were completely dry and an additional 10 (29%) demonstrated a greater than 50% reduction in incontinence episodes 6 months after implantation. Efficacy appeared to be sustained for 18 months. During the therapy evaluation test the group returned to baseline levels of incontinence when stimulation was inactivated. Urodynamic testing confirmed that sacral nerve stimulation did not adversely affect voiding function. Complications included implantable pulse generator site pain in 15.9% of the patients, implant site pain in 19.1% and lead migration in 7.0%. Surgical revision was required in 32.5% of patients with implants to resolve a complication. There were no reports of permanent injury or nerve damage. CONCLUSIONS: Sacral nerve stimulation is safe and effective in treating refractory urinary urge incontinence.

Pelvic floor electrical stimulation for genuine stress incontinence: who will benefit and when?

This study sought to determine the characteristics of women in whom pelvic floor electrical stimulation will reduce stress urinary incontinence. It also evaluates how long electrical stimulation should be used before significant improvements are seen in clinical outcomes. Subjects with genuine stress incontinence were enrolled into a multicenter non-randomized trial. They used electrical stimulation for 15 minutes twice daily or every other day for 20 weeks. At the end of 20 weeks, those with a 50% reduction in leakage episodes on voiding diary ('responders') were compared with those who did not show a 50% reduction ('non-responders'). Thirty-one subjects were enrolled and 28 completed the study. After the treatment period, 19 subjects were defined as responders and 9 as non-responders. There were no significant differences between the two groups in baseline demographics (e.g. age, parity, largest birth weight etc.) other than body mass index (greater in nonresponders). Significant subjective and objective improvements were noted among responders by 10 and 14 weeks, respectively. Compliance was higher in responders during weeks 12-15 of the study (P=0.05). It was concluded that a minimum of 14 weeks of pelvic floor stimulation was necessary before significant objective improvements were seen. Body mass index and patient compliance may affect success.

Pelvic floor electrical stimulation for the treatment of urge and mixed urinary incontinence in women.

OBJECTIVES: To determine the efficacy of daily or every-other-day electrical stimulation in treating detrusor instability (urge) or urge plus genuine stress (mixed) urinary incontinence in women. METHODS: A multicenter, prospective, nonrandomized study enrolled subjects with urge and mixed urinary incontinence assigned to daily or every-other-day treatments (15 minutes twice daily) using pelvic floor stimulation. Outcome measures assessed were (1) leakage episodes, nocturnal episodes, voiding frequency, total voids, and pad count, and (2) patient subjective assessment and quality of life. RESULTS: Seventy-two subjects were enrolled. Sixty-eight subjects completed the 20-week protocol: 33 treated daily and 35 treated every other day. The entire study group (n = 68) experienced a significant decrease in total leaks (P < 0.001), nocturnal episodes (P = 0.001), pad count (P = 0.002), and total voids (P = 0.003) and on visual analog scales. Sixty-nine percent (n = 46) of subjects with urge or mixed incontinence were cured or improved by at least 50%, with 28% (n = 19) being cured. There were no significant differences between daily and every-other-day users. Nonresponse was correlated with number of previous therapies (P < 0.001) and number of vaginal deliveries (P = 0.007). Overall, subjects were 93% compliant with device use, and 72% (n = 47) were satisfied with the therapy. CONCLUSIONS: Twenty weeks of pelvic floor electrical stimulation therapy is effective in treating urge and mixed urinary incontinence, regardless of daily or every-other-day treatments.

Pelvic floor electrical stimulation: a comparison of daily and every-other-day therapy for genuine stress incontinence.

OBJECTIVES: To compare the effectiveness of daily and every-other-day electrical stimulation in treating genuine stress incontinence. METHODS: Subjects with genuine stress incontinence were enrolled in a multicenter, prospective, nonrandomized study and underwent daily or every-other-day pelvic floor stimulation treatments for 15 minutes twice a day. Outcome measures assessed were (1) leakage episodes and pad count; (2) leakage amount, and (3) subject subjective assessment and quality of life. Thirteen subjects treated daily and 15 treated every other day completed the 20-week protocol. One-year follow-up data were available for 21 subjects. RESULTS: No significant differences in primary outcome variables were found between the groups. Subjects treated every other day had significant decreases in total leakage episodes (P = 0.04), pad count (P = 0.04), total voids (P = 0.02), and visual analog scale scores, with stress incontinence cured or improved by 50% in 73% (n = 11). Subjects treated every day had significant decreases in urge episodes (P = 0.03), pad count (P = 0.05), and visual analog scale scores, with 62% (n = 8) cured or improved by 50%. Compliance was higher for subjects treated every other day (P = 0.05). Satisfaction with therapy was 75% (n = 10) for daily treatment and 77% (n = 12) for every-other-day treatment. At 1 year, 70% (n = 7) of subjects who continued device use maintained their cure or improvement status. CONCLUSIONS: Both daily and every-other-day therapy with pelvic floor electrical stimulation are effective in treating genuine stress incontinence. Subjects who continue device use maintain a higher curve or improvement rate.

Management of voiding dysfunction with an implantable neuroprosthesis.

We have been very encouraged by these preliminary results concerning the efficacy and safety of functional electrical neuromodulation in the management of chronic voiding complaints. There are a large number of patients within the standard practice of urology who are potential candidates for this form of management. The techniques of peripheral nerve evaluation and implantation are relatively simple to master and free of significant risks or complications. If the long-term results of the multicenter clinical trial parallel our preliminary results, this is a technique which should be embraced by urologists as a significant therapeutic advance in our field.

Magnetic resonance imaging for assessment of vena caval tumor thrombi: a comparative study with venacavography and computerized tomography scanning.

We assessed the accuracy of magnetic resonance imaging in demonstrating the presence and extent of vena caval tumor thrombi. The study group included 20 patients with vena caval thrombi from renal cell carcinoma (18), renal pelvic transitional cell carcinoma (1) and adrenal pheochromocytoma (1). Preoperative diagnostic studies included magnetic resonance imaging in all patients, inferior venacavography in 16 and computerized tomography scanning in 15. All patients underwent an operation in which the presence and extent of the vena caval thrombus were confirmed. Magnetic resonance imaging accurately delineated the presence and extent of the thrombus in all 20 patients (100%). Venacavography was accurate in 15 patients (94%) but 8 (50%) required a retrograde and antegrade study. Computerized tomography scanning demonstrated the presence of a tumor thrombus in all 15 patients but accurately delineated the cephalad extent of the thrombus in only 5 (33%). In patients with vena caval tumor thrombi magnetic resonance imaging can provide accurate information regarding the extent of vena caval involvement while avoiding the need for an invasive contrast imaging study.

Abdominal radiograph and renal ultrasound versus excretory urography in the evaluation of asymptomatic patients after extracorporeal shock wave lithotripsy.

A prospective study was done to compare the relative efficacy of an abdominal radiograph and renal ultrasound to excretory urography for the evaluation of asymptomatic patients 1 month after extracorporeal shock wave lithotripsy. We evaluated 101 renal units in 84 asymptomatic patients who had undergone extracorporeal shock wave lithotripsy 1 month previously with abdominal radiography, excretory urography and ultrasonography to evaluate the presence of retained stone fragments, dilatation of the collecting system and intrarenal or perirenal fluid collections or masses. The combination of abdominal radiography and ultrasonography identified retained fragments in 62 renal units, while excretory urography identified them in 54. Ultrasonography was less specific in identifying dilatation of part or all of the collecting system; proving falsely positive in 7 renal units and falsely negative in 14 compared to excretory urography. However, the case of obstruction was diagnosed correctly by both modalities. Finally, ultrasound appeared to be more specific and more sensitive in the evaluation of the presence of intrarenal or perirenal abnormalities. We conclude that a combination of abdominal radiography and ultrasonography is as good or better than excretory urography in identifying residual stone fragments and intrarenal or perirenal abnormalities. However, the finding of dilatation of all or part of the collecting system by ultrasonography is nonspecific and probably is better evaluated by excretory urography. We suggest that the routine radiological evaluation of asymptomatic patients 1 month after extracorporeal shock wave lithotripsy could be limited routinely to abdominal radiography and ultrasonography. However, when abnormalities of the collecting system are visualized on these studies excretory urography should be performed.

History of the prosthetic treatment of urinary incontinence.

Prostheses for the treatment of urinary incontinence have evolved from early passive compressive devices, which were limited to use in men, to the current AS-800, which is suitable for both sexes. The device represents continued improvement and streamlining of several earlier models. Parallel advances in surgical technique and perioperative management have made prosthetic treatment of urinary incontinence a well-recognized and desirable solution for a difficult urologic problem.

Bilateral solid renal masses in a young man.

Bilateral solid renal masses presenting in a young patient in the absence of systemic manifestations or genetic abnormalities, such as Von Hippel-Lindau's disease, are difficult diagnostic challenges. Primary renal lymphomas are exceedingly rare. More commonly, renal involvements are caused by lymphoma in the retroperitoneal area. It is important for a urologist to be aware of this diagnostic possibility, since unnecessary removal of a kidney and extensive surgery may be avoided, and because appropriate staging can be performed at exploration.