G Giardiello

Medtronic, Minneapolis, Minnesota, United States

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Publications (15)55.27 Total impact

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    ABSTRACT: Bladder outlet obstruction can negatively affect renal function in the kidney transplant population. Functional obstruction represents a clinical challenge as conventional treatments are either ineffective or not recommended. Sacral neuromodulation was successfully used in functional voiding dysfunction in a kidney transplant patient. This is the first case to be reported in the literature.
    Urologia Internationalis 02/2005; 75(2):187-8. · 1.07 Impact Factor
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    ABSTRACT: Pudendal nerve stimulation has beneficial effects on numerous pelvic floor function impairments such as urinary and/or fecal incontinence, retention, and constipation. In preceding literature the implant technique required a fairly complex and invasive surgery, although recent advances with percutaneous placement of the lead through an introducer have made the procedure much less invasive. We performed staged procedure similar to that of sacral neuromodulation (SNM) to place tined lead near the pudendal nerve, using neurophysiological guidance that allowed accurate pudendal nerve stimulation through either perineal or posterior approach. We have named this approach chronic pudendal nerve stimulation (CPNS). Fifteen neurogenic patients (eight male, seven female) with symptoms of urge incontinence due to neurogenic overactive bladder underwent CPNS. All patients had complete neurophysiological and urodynamic evaluation at baseline and follow-up and were asked to complete voiding and bowel diary for 7 days. During screening, average number of incontinent episodes per day decreased from 7+/-3.3 to 2.6+/-3.3 (P<0.02, paired t-test). Eight patients became continent, two improved by more than 88% (from 9 to 1 daily incontinence episode) and two patients reduced the number of incontinence episodes by 50%. The implantable pulse generator (IPG) was subsequently implanted in those 12 patients. Three patients without improvement did not continue to second stage. In implanted patients with 6 months follow-up, urodynamic evaluation showed an objective improvement in the maximum cystometric capacity which increased from 153.3+/-49.9 to 331.4+/-110.7 ml (P<0.01, paired t-test). The maximum pressure decreased from 66+/-24.3 to 36.8+/-35.9 cmH2O (P=0.059, paired t-test). Eight patients reported significant improvement in bowel function. Chronic pundedal nerve stimulation is feasible. Neurophysiological guidance is mandatory to place the lead near the pudendal nerve either using perineal or posterior approach. Further studies must be carried out to identify the best stimulation parameters and to verify the long term results.
    Neurourology and Urodynamics 01/2005; 24(4):305-9. · 2.67 Impact Factor
  • European Urology Supplements 02/2004; 3(2):170-170. · 3.37 Impact Factor
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    ABSTRACT: Interstitial cystitis (IC), a syndrome characterized by motor and sensory dysfunction of the lower urinary tract, represents a diagnostic and therapeutic challenge even to highly skilled physicians. We investigated the technical feasibility and the clinical efficacy of a prolonged intravesical instillation of RTX by in situ drug delivery system in patients with IC. 5 female patients (mean age 48.7 years) received a prolonged infusion of a saline solution containing 10nM of resiniferatoxin at the flow rate 25microl/h by the MiniMed 407C Infusion Pump (MiniMed Sylmar, CA, USA), connected to sovrapubic 5Fr mono Pigtail catheter, for 10 days. All patients reported frequency, nocturia and urgency, and symptoms of pelvic pain for at least six months. They showed the absence of urinary tract infection within the last three months, the absence of functional disorders of lower urinary tract and no other vesical or urethral pathology. The pre-treatment (PT) frequency/volume (FV) chart and a pain score (VAS score) were recorded. Patients were evaluated after 30 days from the end of infusion (primary end point, PEP) and after three months (secondary end point, SEP). At PEP frequency reduced from 11.3+/-1.39 to 7.4+/-1.51 (p<0.01) and nocturia from 3.6+/-0.54 to 1.2+/-0.44 (p<0.01). A highly significant reduction of pain score was observed at PEP: it decreased to 2.4+/-0.54 from 6.7+/-0.83 (p<0.01). The pain score remained significantly lower at SEP (3.2+/-0.44 p<0.05). Nocturia was also statistically reduced at SEP (1.9+/-0.74) as well as frequency (8.7+/-1.76). No side effects were reported during the infusion as well as after the removal of the catheter. The present study demonstrates that the prolonged intravesical instillation of a drug by in situ drug delivery system is a feasible procedure and seems to support the efficacy of RTX in the treatment of IC patients. However further studies are necessary and mandatory to confirm our results and to define the exact action mechanism of prolonged infusion of RTX, the dosage and the treatment schedule.
    European Urology 02/2004; 45(1):98-102. · 10.48 Impact Factor
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    ABSTRACT: Chronic stimulation of the sacral nerves has now become one of the most accepted stimulation therapies for functional lower urinary tract symptoms refractory to conservative treatment. Despite the existence of a large amount of literature on sacral neuromodulation (SNM) showing a fairly high percent of significant improvement in clinical outcome there are few experimental studies of SNM stimulus parameters and/or neurophysiological monitoring. We evaluated the specific action of SNM on the primary sensory cortical area. Somatosensory evoked potentials (SEPs) of the pudendal and posterior tibial nerves were evaluated in patients implanted with a monolateral permanent quadripolar electrode. A total of 24 patients underwent stage 1 monolateral sacral nerve implantation. Three SEP patterns were evaluated; namely before implantation, 1 month after stage 1 with stimulation set at 21 Hz and again with a pulse rate of 40 Hz. In all patients SNM produced a significant decrease in pudendal SEP latency of the first positive deflection between baseline SNM stimulation at different pulse rates at the ipsilateral and contralateral implant sites. This finding was evidence of the effect of S3 SNM on the cortical sensory area and the specificity of pudendal SEPs in measuring how SNM modulates the afferent pathway from the spinal nerve to the cortical sensory area. Our study confirms previous observations that SNM acts by the afferent pathway at the cortical site level and it sheds light on so-called idiopathic lower urinary tract symptoms. A modification of SEPs induced by SNM seems to be a prognostic factor of clinical outcomes. The action of SNM on the afferent pathway from the sacral area to the somatosensory cortex is specific and neurophysiological evaluation via pudendal SEPs provides evidence to this effect.
    The Journal of Urology 01/2004; 170(6 Pt 1):2323-6. · 3.75 Impact Factor
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    ABSTRACT: In functional urology today chronic stimulation of the sacral nerves has become one of the most accepted methods of stimulation treatment. Many studies have described the advantage of test stimulation prior to implanting the definitive system to enable effective patient selection. We studied a method aimed at improving lead anchoring by developing a self-blocking electrode with a simple placement procedure, in the process creating a 2-stage approach to full percutaneous implantation that allows a long screening period during the first temporary stimulation stage. A new tined lead was specifically designed to allow minimally invasive percutaneous lead placement requiring no incision and no additional fascial anchoring. From September 2001 to November 2002, 15 consecutive patients (3 males and 12 females) 27 to 70 years old (mean age 49) underwent this procedure and were prospectively evaluated. No PNE test was performed. Following the first stage screening phase 12 patients were implanted with the implantable pulse generator (IPG), while 3 who did not respond positively to test stimulation (neurogenic voiding dysfunction, urge incontinence and neurogenic urge incontinence in 1 each) did not undergo IPG implantation and had the tined lead removed under local anesthesia. We did not observe any lead displacement during the screening period (average 38.8 days) or during followup of IPG implanted cases (average 11 months, range 5 to 19). Our results show that the new tined anchoring system is a reliable way to allow truly minimally invasive placement of the chronic lead.
    The Journal of Urology 12/2003; 170(5):1905-7. · 3.75 Impact Factor
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    ABSTRACT: We report on the new technique of sacral nerve stimulation in the treatment of voiding dysfunction. This new technique is characterized by percutaneous approach to the sacral nerves resulting in minimally invasiveness of the procedure and the ability to have patient awake during the electrode placement. Since December 1999, we prospectively evaluated patients who underwent this novel percutaneous technique approach. Thirty-two patients (10 male, 22 female, mean age 43 years) were included and no complications were reported. Average follow-up time was 11 months (range 2-25 months). Main elements of the new technique are also described. The needle is inserted into the sacral foramen to a desired location (usually S3) and metal stylet is then inserted through the needle. With metal stylet only in the foramen, two dilators are successively inserted and the chronic lead is placed through the plastic dilator. Only a very small skin incision is necessary to allow the anchor fixation. Out of the 32 patients who underwent the percutaneous lead placement, 22 received the neurostimulator (IPG). Out of the remaining 10 patients, 4 are still in screening and 6 had unsuccessful results (<50% improvement) and therefore did not undergo the second stage (neurostimulator placement). From the 22 implanted patients, 20 reported 90% improvement in their primary voiding symptoms, 1 had an improvement between 50 and 70% and 1 patient was explanted due to IPG damage following magnetic resonance imaging. There were total of four lead displacements, two occurred where the silicone anchoring was used and the other two occurred when no anchoring was done. Success rate of this technique in selecting patients for the permanent implant is significantly higher than currently reported in the literature. Very beneficial clinical outcome of the implanted patients confirms better patient selection with no complications. Our experience with this technique shows the feasibility of percutaneous lead placement with major advantages such as: (1) use of local anesthesia and possibility to test sensitive responses during implant, (2) the possibility for more accurate patient selection by using the definitive lead for a longer test period before proceeding with the neurostimulator (IPG) implant. The presented percutaneous technique requiring fascial lead fixation represents a safe and effective method of Sacral Neuromodulation Therapy.
    European Urology 01/2003; 43(1):70-4. · 10.48 Impact Factor
  • European Urology Supplements - EUR UROL SUPPL. 01/2003; 2(1):143-143.
  • European Urology Supplements - EUR UROL SUPPL. 01/2003; 2(1):141-141.
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    ABSTRACT: 176 Cappellano F 1, Bertapelle P2, Spreafico L 3, Del Popolo G4, Kocjancic E5, Donelli A 6, Ponzi P 7, Giardiello G 8, Caprari F 7, Catanzaro F1 1. Multimedica Milano, 2. CTO Maria Adelaide Torino, 3. P. O. Montecchio Emilia, 4. Unità Spinale Careggi Firenze, 5. Ospedale Maggiore Carità Novara, 6. Medtronic Italia , 7. Centro Studi Fondazione Medtronic, 8. Medtronic Italia ECONOMICAL AND SOCIAL IMPACT OF SACRAL NERVE STIMULATION THERAPY IN 62 PATIENTS WITH LOWER URINARY TRACT DYSFUNCTION Aims of Study Lower urinary tract dysfunction (LUTS) such as detrusor instability or urinary retention are strongly impacting pathologies for both quality of life, economical aspects and social living ranging from the single patient to the whole social and economical envi ronment including family activities. The aim of our investigation is to record changes in frequency of hospitalizations, urological and general practitioner visits before and after sacral nerve stimulation therapy implant. Expenses for pads, catheters and drugs are also investigated. Methods From February 2000 to September 2002 on 62 patients (mean age 50 years old, from 22 to 70) enrolled in the economic session of the Italian Sacral Nerve Modulation Registry. Social and economical data were recorded in order to compare costs with clinical results of sacral nerve modulation therapy in patients with LUTS. On the whole population considered 41 were incontinent patients (61 % female) mean age 53 ( 22-68) and 21 patient ( 71 % female) mean age 46 (25-70) affected by chronic urinary retention. Results We performed a quarterly based analysis, comparing the baseline data to the last follow up available (12th month). Visits to the general practitioner decreased from 1.1 to 0.05 (p<0.01), visits to the urologist did not change significantly from baseline (1.5 to 1.2). Diagnostic tests decreased from 2 to 0.8 (p<0.01). In the use of pads we observed a major change from a daily use of 2.1 (three months expenses per patient of € 120.96) to 0.5 (three months expenses per patient of € 28.8) (p=0.08); and for urinary retention the use of catheters decreased from 1,1baseline (three months expenses per patient of € 178.2) to 0.1 at 12 months (three months expenses per patient of € 16.2) (p=0.09). Costs of drug consumption decreased significantly (p<0.05) from € 47.24 to € 10.53. Conclusions Sacral nerve modulation has demonstrated to be efficient in improving the economic management of patients with LUTS. This is highly evident in the reduction of daily consumption of pads and catheters (which is the major cost-driver of urinary disorders), but also results in a reduction of costs due to general practitioner visits, urological visits, diagnostic tests, and drug consumption. Urological visits do not change significantly from baseline to 12 months after the implant: this could be due to fine-tuning of therapy modulation setting. Optimal treatment can be defines at the end of a “process” which could take several months, during which specialist visits decrease progressively. Generally, one year after the implant the therapy is stabilized; a longer follow up is therefore needed in order to evaluate this aspect. Furthermore, the reduction in the use of pads and catheters not only affects direct costs but also patients’ social interaction with positive effects on quality of life (already published elsewhere(1)). References (1) Cappellano F, Bertapelle P, Spinelli M, Catanzaro F, Carone R, Zanollo A, De Seta F, Giardiello G for the Italian Group of Sacral Neuromodulation (GINS). Quality of life assessment in patients who undergo sacral neuromodulation implant for urge incontinence: an addtional tool for evaluating outcome. The Journal of Urology, Vol. 166, 2277- 2290;December 2001.
    Value in Health 01/2003; 6(6):702-702. · 2.19 Impact Factor
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    ABSTRACT: We investigated the impact of sacral neuromodulation on quality of life and assessed the importance of quality of life for determining the success of sacral neuromodulation in patients with detrusor hyperactivity, including instability and hyperreflexia. We also compared it with parameters documented in a voiding diary. From May 1998 to December 2000, 82 female and 31 male patients 17 to 79 years old (mean age 51.1) with urge incontinence (63), urgency/frequency (5), voiding disturbance (41) and pelvic pain (4) resistant to conservative treatment were enrolled in a national prospective registry after showing a positive response to percutaneous nerve evaluation testing. Of the patients 47 who were 32 to 79 years old (mean age 59.2) with urge incontinence due to detrusor instability and 16 who were 27 to 51 years old (mean age 51.5) with hyperreflexia were asked to complete a validated self-reporting incontinence domain specific quality of life questionnaire before, and 3, 6, 9, 12, 18, 24 and 36 months after implantation. Compared with baseline the quality of life index significantly improved at each followup, which strongly correlated with the decrease in the number of incontinence episodes. Evaluating quality of life may be an additional useful tool for assessing the results of sacral neuromodulation for urge incontinence. Our study confirms that sacral neuromodulation is effective therapy for urge incontinence that can have a positive effect on patient quality of life.
    The Journal of Urology 01/2002; 166(6):2277-80. · 3.75 Impact Factor
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    ABSTRACT: The Italian Register was created in February 1997 to collect the national results of sacral neuromodulation. All Italian centers at which sacral neuromodulation is performed were invited to participate in our study. We present the results from retrospective and prospective registers. A total of 196 patients underwent permanent implantation of sacral neuromodulation and were enrolled in the Italian register. There were 18 males and 75 females in the retrospective, and 28 males and 75 females in the prospective studies. Student's t test was used to compare paired values, and the Wilcoxon rank sum and nonparametric tests were used when necessary. Mean incontinent episodes daily plus or minus standard deviation for patients with detrusor instability went from 5.4 +/- 3.9 to 1.1 +/- 1.6 (median 5 and 0, respectively) at 12-month followup (p <0.001). For idiopathic retention average residual volume decreased from 277 to 108 cc (median 287 and 80, respectively), and 50% of patients stopped catheterization and another 13% catheterized once daily at 1-year after implantation. With neurogenic voiding disturbances, the results fluctuated with time from a minimum of 33% to a maximum 66% of patients who did not catheterize at 6-month followup and 12 months after implantation, respectively. At 12-month followup, 50% of patients with hyperreflexia had less than 1 incontinent episode daily. The problem was completely solved in 66% of patients in the retention group. Of patients in the urge incontinent population 39% were completely dry and 23% had less than 1 incontinent episode daily. Sacral neuromodulation is effective therapy for treating lower urinary tract symptoms resistant to less invasive therapy.
    The Journal of Urology 09/2001; 166(2):541-5. · 3.75 Impact Factor
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    ABSTRACT: There are several options in the treatment of fecal incontinence; it is often difficult to choose the most appropriate, adequate treatment. The consolidated experience gained in the urologic field suggests that sacral nerve stimulation may be a further option in the choice of treatment. The aim of our study was to evaluate the preliminary results of the peripheral nerve evaluation test obtained in a multicenter collaborative study on patients with defecatory and urinary disturbances. Forty patients (9 males; mean age, 50.2; range, 26-79 years) underwent the peripheral nerve evaluation test, 28 (70 percent) for fecal incontinence and 12 (30 percent) for chronic constipation. Fourteen (35 percent) patients also had urinary incontinence; six had urge incontinence, two had stress incontinence, and six had retention incontinence. Associated diseases were scleroderma (2 patients), spinal injuries (4 patients), and syringomyelia (1 patient). All the patients underwent preliminary investigations with anorectal manometry, pudendal nerve terminal motor latency testing, anal ultrasound, defecography, and if required, urodynamic tests. The electrode for sacral nerve stimulation was positioned percutaneously under local anesthesia in the S2 (4), S3 (34), or S4 (1) foramen unilaterally (1 patient not accounted for because of no response to acute test), based on the best motor and subjective responses of paresthesia of the pelvic floor. Stimulation parameters were average amplitude, 2.8 (range, 1-6) V and average frequency, 15 to 25 Hz. The mean duration of the tests was 9.9 (range, 7-30) days; tests lasting fewer than seven days were not evaluated. There were four early displacements of the electrode. In 22 of the 25 evaluable patients with fecal incontinence, there was an improvement of symptoms (88 percent), and 11 (44 percent) were completely continent to liquid or solid stools, whereas in 7 symptoms were unchanged. Mean number of episodes of liquid or solid stool incontinence per week was 8.1 (range, 4-18) in the prestimulation period and 1.7 (range, 0-12) during the peripheral nerve evaluation test. (P = 0.001; Wilcoxon's signed-rank test). The most important manometric findings were: increase of maximum rest pressure (39.4 +/- 7.3 vs. 54.3 +/- 8.5 mmHg; P = 0.014, Wilcoxon's test) and maximum squeeze pressure (84.7 +/- 8.8 vs. 99.5 +/- 1.1 mmHg; P = 0.047), reduction of initial threshold (63.6 +/- 5.2 vs. 42.4 +/- 4.7 ml; P = 0.041) and urge sensation (123.8 +/- 0.6 vs. 78.3 +/- 8.9 ml; P = 0.05). An improvement was also found in patients with constipation, with reduction in difficulty emptying the rectum, with prestimulation at 7 (range, 2-21) episodes per week and end of peripheral nerve evaluation test at 2.1 (range, 0-6) episodes per week, P < 0.01) and in the number of unsuccessful visits to the toilet, which dropped from 29.2 (7-24) to 6.7 (0-28) per week (P = 0.01). The most important manometric findings in constipated patients were an increase in amplitude of maximum squeeze pressure during sacral nerve stimulation (prestimulation, 63 +/- 0 mm Hg; end of peripheral nerve evaluation test, 78 +/- 1 mm Hg; P = 0.009) and a reduction in rectal volume for urge threshold (prestimulation, 189 +/- 52 ml; end of peripheral nerve evaluation test, 139 +/- 45 ml; P = 0.004). In functional bowel disorders short-term sacral nerve stimulation seems to be a useful diagnostic tool to assess patients for a minor invasive therapy alternative to conventional surgical procedure.
    Diseases of the Colon & Rectum 09/2001; 44(9):1261-7. · 3.34 Impact Factor
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    ABSTRACT: PURPOSE: There are several options in the treatment of fecal incontinence; it is often difficult to choose the most appropriate, adequate treatment. The consolidated experience gained in the urologic field suggests that sacral nerve stimulation may be a further option in the choice of treatment. The aim of our study was to evaluate the preliminary results of the peripheral nerve evaluation test obtained in a multicenter collaborative study on patients with defecatory and urinary disturbances. METHODS: Forty patients (9 males; mean age, 50.2; range, 26–79 years) underwent the peripheral nerve evaluation test, 28 (70 percent) for fecal incontinence and 12 (30 percent) for chronic constipation. Fourteen (35 percent) patients also had urinary incontinence; six had urge incontinence, two had stress incontinence, and six had retention incontinence. Associated diseases were scleroderma (2 patients), spinal injuries (4 patients), and syringomyelia (1 patient). All the patients underwent preliminary investigations with anorectal manometry, pudendal nerve terminal motor latency testing, anal ultrasound, defecography, and if required, urodynamic tests. The electrode for sacral nerve stimulation was positioned percutaneously under local anesthesia in the S2 (4), S3 (34), or S4 (1) foramen unilaterally (1 patient not accounted for because of no response to acute test), based on the best motor and subjective responses of paresthesia of the pelvic floor. Stimulation parameters were average amplitude, 2.8 (range, 1–6) V and average frequency, 15 to 25 Hz. RESULTS: The mean duration of the tests was 9.9 (range, 7–30) days; tests lasting fewer than seven days were not evaluated. There were four early displacements of the electrode. In 22 of the 25 evaluable patients with fecal incontinence, there was an improvement of symptoms (88 percent), and 11 (44 percent) were completely continent to liquid or solid stools, whereas in 7 symptoms were unchanged. Mean number of episodes of liquid or solid stool incontinence per week was 8.1 (range, 4–18) in the prestimulation period and 1.7 (range, 0–12) during the peripheral nerve evaluation test. (P=0.001; Wilcoxon's signed-rank test). The most important manometric findings were: increase of maximum rest pressure (39.4 7.3vs. 54.3 8.5 mmHg;P=0.014, Wilcoxon's test) and maximum squeeze pressure (84.7 8.8vs. 99.5 1.1 mmHg;P=0.047), reduction of initial threshold (63.6 5.2vs. 42.4 4.7 ml;P=0.041) and urge sensation (123.8 0.6vs. 78.3 8.9 ml;P=0.05). An improvement was also found in patients with constipation, with reduction in difficulty emptying the rectum, with prestimulation at 7 (range, 2–21) episodes per week and end of peripheral nerve evaluation test at 2.1 (range, 0–6) episodes per week, (P<0.01) and in the number of unsuccessful visits to the toilet, which dropped from 29.2 (7–24) to 6.7 (0–28) per week (P=0.01). The most important manometric findings in constipated patients were an increase in amplitude of maximum squeeze pressure during sacral nerve stimulation (prestimulation, 63 0 mm Hg; end of peripheral nerve evaluation test, 78 1 mm Hg;P=0.009) and a reduction in rectal volume for urge threshold (prestimulation, 189 52 ml; end of peripheral nerve evaluation test, 139 45 ml;P= 0.004). CONCLUSIONS: In functional bowel disorders short-term sacral nerve stimulation seems to be a useful diagnostic tool to assess patients for a minor invasive therapy alternative to conventional surgical procedure.
    Diseases of the Colon & Rectum 08/2001; 44(9):1261-1267. · 3.34 Impact Factor
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    ABSTRACT: Sacral nerve modulation appears to offer a valid treatment option for some patients with fecal incontinence and functional defects of the internal anal sphincter or of the striated muscle. Sixteen patients with fecal incontinence (4 males; mean age, 51.4 (range, 27-79) years) with intact or surgically repaired (n = 1) anal sphincter underwent permanent sacral nerve stimulation implant. Cause was traumatic in two patients, and associated disorders included scleroderma (2 patients) and spastic paraparesis (1 patient); eight (50 percent) of the patients also had urinary incontinence, and two (12.5 percent) had nonobstructive urinary retention. All patients were selected on the basis of positive findings from at least one peripheral nerve evaluation. The stimulating electrode was positioned in the S2 (1 patient), S3 (14 patients), or S4 (1 patient) sacral foramen. Mean follow-up was 15.5 (range, 3-45) months. Mean preimplant Williams score decreased from 4.1 +/- 0.9 (range, 2-5) to 1.25 +/- 0.5 (range, 1-2) (P = 0.01, Wilcoxon test), and the number of incontinence accidents for liquid or solid stool in 14 days decreased from 11.5 +/- 4.8 (range, 2-20) before implant to 0.6 +/- 0.9 (range, 0-2) at the last follow-up. Important manometric data were an increase in mean maximal pressure at rest of 37.7 +/- 14.9 mmHg (implantable pulse generator 49.1 +/- 18.7, P = 0.04) and in mean maximal pressure during squeeze (prestimulation 67.3 +/- 21.1 mmHg, implantable pulse generator 82.6 +/- 21.0, P = 0.09). Neuromodulation can be considered an option for fecal incontinence. However, an accurate clinical and instrumental evaluation and careful patient selection are required to optimize outcome.
    Diseases of the Colon & Rectum 08/2001; 44(7):965-70. · 3.34 Impact Factor