Paul Pettit

Sacral nerve stimulation for fecal incontinence: Results of a 120-patient prospective multicenter study

Background:Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods:Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results:A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2–69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%–90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion:Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Purpose: Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics. Materials and Methods: Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co‐primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed. Results: OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (−2.65 vs −0.87, p <0.001) and 22.9% vs 6.5% of patients became completely continent. A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale (60.8% vs 29.2%, p <0.001). All other overactive bladder symptoms improved vs placebo (p ≤0.05). OnabotulinumtoxinA improved patient health related quality of life across multiple measures (p <0.001). Uncomplicated urinary tract infection was the most common adverse event. A 5.4% rate of urinary retention was observed. Conclusions: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

Sacral neuromodulation: new applications in the treatment of female pelvic floor dysfunction.

Purpose of review The first sacral nerve stimulators implanted by Tanagho and Schmidt (1981) were performed for the indications of urinary urge incontinence, urgency-frequency, and nonobstructive urinary retention. Since that time, observations have been made for benefits beyond voiding disorders. These additional benefits have included re-establishment of pelvic floor muscle awareness, resolution of pelvic floor muscle tension and pain, decrease in vestibulitis and vulvadynia, decrease in bladder pain (interstitial cystitis), and normalization of bowel function. Recent findings Therapy for fecal incontinence in patients with a structurally intact sphincter mechanism appears to be very promising. Investigators agree that there is a role for sacral nerve stimulation in patients with urge fecal incontinence that have failed conservative efforts. Objective manovolumetric testing shows an increase in resting pressure, an increase in voluntary contraction pressure, a decrease in rectal volumes which cause first urge, a decrease in rectal volume to initiate first urge to defecate, and an increase in duration of maximum squeeze pressure. Intractable interstitial cystitis is defined as patients that have failed conventional therapy. Historically, the only option remaining was extirpative surgery or diversion. Maher et al. reported on patients with intractable interstitial cystitis who had undergone sacral nerve stimulation. They found that 73% of these patients had a reduction in pelvic pain, daytime frequency, nocturnal urgency and an increase in average voided volumes. The final area of interest concerns refractory pelvic pain. Siegal et al. reported a decrease in severity, number of hours of pain, and improved quality of life measures in patients who underwent transforamenal sacral nerve stimulations. These patients had all failed conventional pain therapy. Summary While the data are encouraging in these new arenas of pelvic floor disorders, investigators acknowledge the need for multicenter, statistically powered studies to evaluate the validity of these findings.

Laparoscopic Placement of Ventriculoperitoneal Shunts: Preliminary Report

We used a laparoscopic technique for the percutaneous placement of the peritoneal end of cerebrospinal fluid shunts in adult patients with obstructive or normal-pressure hydrocephalus. Concurrent with the initial cranial part of the procedure, pneumoperitoneum is established in a routine fashion, and a video-laparoscope and grasping forceps are inserted into the peritoneal cavity. With use of a pacemaker introducer kit, the peritoneal catheter is placed percutaneously under direct laparoscopic vision through a small upper abdominal incision into the peritoneal cavity. At the completion of the procedure, the patency of the assembled shunt system can be verified by observing free flow of cerebrospinal fluid from the catheter tip as the valve is being pumped. We found that this technique is particularly useful in technically challenging cases--for example, those involving obese patients and those who have undergone multiple abdominal operations. No complications associated with the technique were encountered.

Current opinion: complications and troubleshooting of sacralneuromodulation

The complications of sacral neuromodulation have been minimized as technology has improved. The main surgical complication remains to be surgical site infection. We review evidence-based suggestions and procedure-specific techniques that reduce the infection rate to less than 2%. In the past, surgical revision was reported as high as 40%. The current revision rate at Mayo Clinic Florida is 10%. The most common reason for surgical revision is either battery end-of-life or loss of effectiveness. We review the best practices of the procedure and a systematic approach to troubleshoot loss of effectiveness.

Ventriculoperitoneal shunt placement with video-laparoscopic guidance

Laparoscopy is the endoscopic visualization of the contents of the peritoneal cavity. It has been used by gynecologic surgeons and gastroenterologists since the middle of the 20th century. Laparoscopy has recently become a more widely used tool in other surgical specialties, mainly general and urologic surgery. In the neurosurgical literature, the use of laparoscopy has been described only in the retrieval of disconnected peritoneal shunts in the pediatric population. We now report our experience with placement of the peritoneal end of ventriculoperitoneal shunts under direct laparoscopic vision.

Lumbar peritoneal shunting with video-laparoscopic assistance: a useful technique for the management of refractory postoperative lumbar csf leaks

BACKGROUND Cerebrospinal fistulas and pseudomeningoceles can occur after lumbar spinal surgery, and are sometimes refractory to direct repair, external drainage, and blood patches. The authors report a technique for cerebrospinal fluid (CSF) diversion from the lumbar spine to the peritoneum to assist with the management of these difficult situations. METHODS Using video-laparoscopic assistance, two shunts are placed from the lumbar region into the peritoneal cavity: first, a lumbar subarachnoid space to peritoneum shunt; and second, a meningocele cavity to peritoneum shunt. Patients are ambulated immediately after the procedure. External drains are not used. RESULTS Four patients with refractory CSF leaks were successfully managed with this technique. Complications associated with prolonged bedrest and external drains were avoided. Ancillary procedures were minimized, and hospital stay was shortened. Laparoscopic assistance offered verification of accurate placement of the peritoneal catheter and shortened operative times. CONCLUSIONS Dual lumbar peritoneal shunts (intrathecal-peritoneal and meningocele cavity-peritoneal), placed with laparoscopic assistance, proved effective in the management of four patients with postoperative lumbar CSF leaks, who had failed to respond to conventional treatment.

Implantable Neuromodulation for Urinary Urge Incontinence and Fecal Incontinence: A Urogynecology Perspective

Implantable sacral nerve stimulation is a minimally invasive, durable, and reversible procedure for patients with urinary urge and fecal incontinence who are refractory to conservative therapy. The therapy is safe compared with other surgical options. An intact external or internal rectal sphincter is not a prerequisite for success in patients with fecal incontinence.

Transvaginal Trigger Point Injections for Pelvic Floor Myofascial Spasm: A Retrospective Review of Pain Assessment and Development of a Treatment Algorithm.

Study Objective: To determine the safety and feasibility of single incision sling procedures (SIS) performed in an office based surgical setting among patients with stress urinary incontinence (SUI). Design: Retrospective study. Setting: Urogynecology office based Class A ASU. Patients: Women who underwent SIS procedures in an office setting. Intervention: SIS procedures were performed under local anesthesia with or without oral sedation. Measurements and Main Results: A total of 27 patients underwent a SIS procedure from 01/2011 to 02/2015 for the treatment of SUI. 9/ 27 patients (33.3%) had SUI with urethral hypermobility as the primary diagnosis, 1/27 patients (3.7%) had intrinsic sphincter deficiency (ISD) with urethral hypermobility, and 17/27 patients (63%) had stress-predominant mixed urinary incontinence. 27/27 (100%) of patients received administration of a local anesthetic, 24/27 patients (89%) also received oral sedation 1 hour prior to the procedure. There were no intraoperative complications. The estimated blood loss ranged from minimal to 50 cc. 9/27 patients (33.3%) reported minimal immediate postoperative pain, while 18/27 patients (66.7%) experienced no postoperative pain. No patients experienced urinary retention/voiding dysfunction post-procedure. 27/27 patients (100%) were discharged without a catheter. All the patients tolerated the procedure well, with no procedures having to be aborted for any reason. The last postoperative visit ranged from 6 weeks to 11 months. 1/27 patients (3.7%) complained of dyspareunia. 1/27 (3.7%) had mesh exposure/ revision; 1/27 (3.7%) had de novo overactive bladder symptoms. The one patient with preoperative ISD, experienced mild persistent SUI. 26/27 patients (96%) reported resolution of the SUI. Conclusion: We demonstrated the safety and feasibility of performing SIS procedures in an office-based setting. Clinical outcomes were comparable to those procedures performed in a traditional hospital or ambulatory surgical care setting. Larger clinical trials may be necessary before SIS placement in the ASU setting can be considered to be the standard setting for this procedure.

Trigger Point Injections for Pelvic Floor Myofascial Spasm Refractive to Primary Therapy

Introduction A retrospective chart review was conducted of visual analog scale (VAS) scores completed before and after trigger point injections (TPIs) for pelvic floor myofascial spasm to evaluate response. Methods Sixty-eight female patients who underwent TPIs from October 9, 2007 to March 12, 2015 were included. The primary end point was the difference between scores. Secondary analyses were conducted for patients who needed repeat TPIs. Descriptive and paired t test analyses were used. Results The key result was an improvement in VAS scores for 65% (44/68) of patients (p<0.0001). The median pre-injection VAS score was 7 (1 to 10), (mean 6.3). The median post-injection VAS score was 4 (0 to 9), (mean 4.3). The median difference between scores in patients who improved was 3 (1 to 8), (mean 3.6). Seventeen of 68 (25%) patients needed repeat TPI, and the median time between injections was 1.5 months (1 to 7 months), (mean 2.2 months). When analyzing pre-injection VAS scores in patients who underwent subsequent repeat injection when compared to patients who did not require repeat injection, there was no difference (p = 0.32). In addition, the differences between pre- and post-injection VAS scores in the patients who underwent repeat injection and those who did not was not significant (p = 0.26). Conclusions We report on 68 women who underwent TPIs, with an improvement in VAS pain scores in 65%. It appears that TPIs for pelvic floor myofascial spasm are successful in reducing pain scores for patients who are refractory to primary therapy.