Ten-Year Experience With Continuous Low-Frequency Pelvic Somatic Nerves Stimulation for Recovery of Voluntary Walking in People With Chronic Spinal Cord Injury: A Prospective Case Series of 29 Consecutive Patients.

OBJECTIVE: The purpose of this study was to report on long-term effects of low-frequency stimulation of the pelvic somatic nerves in patients with chronic spinal cord injuries who underwent laparoscopic implantation of neuroprosthesis (LION) in the pelvic lumbosacral nerves. DESIGN: Observational case report. SETTING: Tertiary referral unit specialized in advanced gynecologic surgery and neuropelveology. PARTICIPANTS: Patients (N=29) with chronic SCI who underwent a LION procedure to the pelvic lower motor neurons for the recovery of standing and walking motion. Our study is not composed of preselected patients but includes patients across the entire range of SCIs: patients with paraplegia, patients with tetraplegia (except for high tetraplegia), patients with complete and incomplete SCIs, and even patients with flaccid or spastic paralysis. INTERVENTION: Patients underwent in-body functional electrical stimulation-assisted locomotor training and continuous low-frequency pelvic lumbosacral nerve neuromodulation. MAIN OUTCOME MEASURES: Evolution of American Spinal Injury Association (ASIA) sensory score, ASIA Lower Extremity Motor Score, and Walking Index. RESULTS: All patients with incomplete SCI regained some voluntary control of previously paralyzed muscles after a few months of stimulation training. With a follow-up of 9 years, 20 patients (71.4%) were able to demonstrate an electrically assisted voluntary extension of the knee. Twenty-six patients could get to their feet when the pacemaker was switched on (92.8%). Five patients could walk <10 m (17.85%) at the bar. Nineteen patients (Abbreviated Injury Score [AIS] A: n=8; AIS B: n=9; AIS C: n=2) could walk >10 m (67.8%), 8 of them only at the bar (28.5%) and 11 of them with the aid of crutches or a walker and without braces (40%). CONCLUSIONS: The major finding of our study is that 17 of 25 patients with complete motor chronic SCI (68%) developed enough recovery of supraspinal control of leg movements that voluntary walking became feasible, even though a minimal amount of stimulation may be required.

Does low-frequency pelvic nerves stimulation in people with spinal cord injury allow for the formation of electrical pathways responsible for the recovery of walking functions?

Over the last ten years, we have published various manuscripts on the recovery of assisted voluntary walking in people with chronic spinal chord injuries (SCI), following laparoscopic implantation of stimulation electrodes on the pelvic somatic nerves - the LION procedure. Although at the beginning of this research the objective was to allow "robotic" walking by stimulating the muscles, we realized relatively quickly that continuous low frequency stimulation of the pelvic nerves might allow the recovery of voluntary functions of the lower limbs and of the trunk necessary for walking: Seventeen out of a total of twenty-five complete motor chronic SCI-patients (68%) developed enough recovery of supra-spinal control of leg movements, that voluntary walking became feasible, even though a minimal amount of stimulation may be required. All current theories for recovery these voluntary functions below the spinal cord lesion are based on the induced regrowth or reconnection of nerves or at least the recovery of functional anatomical pathways. In this manuscript we formulate the hypothesis that electrical stimulation could be responsible for inducing the formation of "electrical pathways" within the body, which under conditions of electrical stimulation might enable the transport of necessary information from the brain to below the spinal cord lesion allowing voluntary movements of the lower limbs.

The LION Procedure to the Pelvic Nerves for Recovery of Locomotion in 18 Spinal Cord Injured Peoples - A Case Series.

We report on unexpected findings in 18 spinal cord injured peoples who underwent a laparoscopic bilateral implantation of neuroprosthesis (LION procedure) to the sciatic/femoral nerves pelvic somatic nerves for functional electrical stimulation (FES)-assisted locomotor training and continuous low-frequency electrical stimulation. Fifteen patients were paraplegics, three low tetraplegics, all of them fully dependent on a wheelchair. After a training period of at least one year, all patients not only started with electrical-assisted standing/stepping using a walker or crutches, but also developed some progressive caudalward recovery of lumbosacral sensoric functions and of supraspinal control of voluntary movements below the lesions. Twelve patients are currently capable of weight-bearing standing and stepping with crutches by simultaneous electrical stimulation (the best of the series for 2.6km), and six of them are capable of walking several meters (the best of the series for 400m) without electrical stimulation. Our findings suggest that FES-assisted locomotor training in combination with continuous low-frequency pelvic nerves in spinal cord injury patients may induce changes that affect the central pattern generator and allows supra- and infraspinal inputs to engage residual spinal or extra spinal pathways for reconnection.

A novel implantation technique for pudendal nerve stimulation for treatment of overactive bladder and urgency incontinence.

Herein is described laparoscopic implantation of a neuroprosthesis to the pudendal nerve for treatment of non-neurogenic bladder overactivity. This case series study was performed at a tertiary referral unit that specializes in advanced gynecologic surgery and neuropelveology. Fourteen consecutive male and female patients underwent laparoscopic implantation of an electrode to the endopelvic portion of the pudendal nerve for pudendal neuromodulation. All procedures were performed successfully via laparoscopy, without any complications. The mean operative time for the entire procedure was 18 minutes. After a successful test phase of external stimulation, 11 patients (78.57%) underwent implantation of a permanent generator. These patients demonstrated a mean (SD) decreased micturition frequency, from 25 (11.7; range, 13-50) per day on average to 10.18 (2.7; range, 7-15) at final evaluation (mean follow-up, 18 months; range 9-49 months). Nocturia decreased from 5.82 (4.2; range, 3-18) to 2.18 (1.08; range, 1-5) micturitions per night. Cystometric bladder capacities increased from 159 mL (53; range, 80-230 mL) to 312 mL (104.9;160-500 mL). Mean incontinence episodes at the initial evaluation, based on a 3-day voiding diary, were 8.1. At final evaluation, 6 patients were completely dry. Number of pads used per day decreased from 7.3 (4.2) to 1.6 (2.3). No lead dislocation or migration occurred. It was concluded that laparoscopic implantation of a neuroprosthesis to the pudendal nerve is an effective, safe, and reproducible day procedure for treatment of intractable non-neurogenic overactive bladder with urinary urgency incontinence.

A new technique of laparoscopic implantation of stimulation electrode to the pudendal nerve for treatment of refractory fecal incontinence and/or overactive bladder with urinary incontinence.

STUDY OBJECTIVE: To show a new technique of laparoscopic implantation of electrodes for stimulation of the pudendal nerve for treatment of fecal incontinence and/or overactive bladder with urinary incontinence. DESIGN: Step-by-step explanation of the technique using videos and pictures (educative video). SETTING: Hyperactivity of the bladder with urinary incontinence, in particular the non-neurogenic form of the condition, but also fecal incontinence may affect millions of women worldwide without any comorbidities and in particular without any neurologic disorders or prolapsed organs. First-line conservative treatments do not always result in sufficient improvement of symptoms and are often associated with disabling adverse effects leading to treatment failure. Electrical stimulation of the pelvic nerves has emerged as an alternative and attractive treatment in refractory cases. A novel technique of implantation of an electrode to the pudendal nerve has been developed for treatment of fecal incontinence and of hyperactivity of the bladder with urinary incontinence. The laparoscopic approach is the only technique that enables placement of an electrode in direct contact with the endopelvic portion of the pudendal nerve within the protection of the pelvis. INTERVENTION: Laparoscopic transperitoneal implantation of a stimulation electrode to the endopelvic portion of the pudendal nerve. CONCLUSION: This technique of transperitoneal placement of an electrode to the endopelvic portion of the pudendal nerve is an effective, safe, and reproducible day procedure for treatment of intractable hyperactive bladder, urinary incontinence, fecal incontinence, and a combination of both forms of incontinence.

Recovery of sensory and supraspinal control of leg movement in people with chronic paraplegia: a case series.

OBJECTIVE: To report on unexpected findings in 4 patients with chronic paraplegia who underwent the laparoscopic implantation of neuroprosthesis procedure in the pelvic lumbosacral nerves. DESIGN: Observational case series. SETTING: Tertiary referral unit specialized in advanced gynecological surgery and neuropelveology. PARTICIPANTS: Three patients with incomplete American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade B (n=2) and AIS grade C (n=1) spinal cord injury (SCI) and 1 patient with flaccid complete chronic SCI (AIS grade A) (n=1). INTERVENTION: Functional electrical stimulation (FES)-assisted locomotor training and continuous low-frequency pelvic-lumbosacral neuromodulation. MAIN OUTCOME MEASURES: Change in ASIA Lower Extremity Motor Scores, ASIA sensory scores for light touch and pinprick sensation, and Walking Index for Spinal Cord Injury scores. RESULTS: All 4 patients developed progressive recovery of some sensory and voluntary motor functions below the lesions. Three are currently capable of voluntary weight-bearing standing and walking a few meters with a walker without FES. The first patient with the longest follow-up is even capable of electrically assisted standing/walking with 2 crutches without braces or assistance for a distance of about 900 meters, and of weight-bearing standing and walking for 30 meters with a walker without stimulation. CONCLUSIONS: We report unexpected sensory and locomotor recovery in 4 people with paraplegia with SCI. Our findings suggest that FES-assisted locomotor training with continuous low-frequency pelvic nerve stimulation in patients with SCI may induce changes that affect the central pattern generator and allow supra- and infraspinal inputs to engage residual spinal pathways.

Risks, symptoms, and management of pelvic nerve damage secondary to surgery for pelvic organ prolapse: a report of 95 cases.

INTRODUCTION AND HYPOTHESIS: This study aims to report pelvic nerve damage secondary to surgical treatment of pelvic organ prolapse and the role of laparoscopy in the diagnosis and treatment of such nerve damage. METHODS: Ninety-five consecutive patients complaining of pain and/or bladder or bowel dysfunction following surgery for pelvic prolapse underwent laparoscopic exploration for pelvic neuropathy. RESULTS: A mean reduction in visual analog score (VAS) from 8.9 (± 0.96; 6-10) preoperatively to 2.9 (± 2.77; 0-6) at 1-year follow-up was obtained in patients after laparoscopic nerve decompression (n = 90; p < 0.001). Success, defined as a reduction in VAS score of greater than 50%, was obtained in 84% of patients. Sixty-five patients (68%) discontinued the regular use of analgesics. CONCLUSIONS: Because secondary nerve damage can appear months or years after the primary procedure, long-term follow-up is mandatory and should focus on nerve damage as well as anatomical and functional outcomes. Laparoscopy is a unique method for etiologic diagnosis and neurosurgical treatment of such nerve lesions through decompression or implantation of an electrode for neuromodulation.

New strategies of pelvic nerves stimulation for recovery of pelvic visceral functions and locomotion in paraplegics.

AIMS: To present new strategies of pelvic nerves stimulation to enhance micturition, to control spasticity, and to recover locomotion in paraplegics. METHODS: Three consecutive patients-Th5, Th7, and Th10 spinal cord injured-underwent laparoscopic transperitoneal implantation of octipolar electrodes to the sciatic and the pudendal nerves and one double extradural Brindley-Finetech electrode bilaterally to the sacral nerve roots S3 and S4. The two octipolar electrodes were connected to an implanted rechargeable generator, while the double Brindley electrode was connected to an implanted Brindley-Finetech receiver block. RESULTS: Continuous stimulation of the sciatic and pudendal nerves at a frequency of 20 Hz in all three patients permits complete control of the spasticity of the lower extremities and of reflex incontinence. Bladder emptying is obtained by sacral nerve roots stimulation alone in the first patient, by simple interruption of pudendal stimulation in the second ("pudendal-deblockade") and by simultaneous sacral nerve roots stimulation with high-frequency pudendal nerve blockade in the third patient. Functional electrical stimulation of the femoral nerves enables the Th4 paraplegics lower-limb cycling and the two further patients standing and alternative locomotion. CONCLUSION: This short series indicated that laparoscopic implantation of neuroprothesis to the pelvic nerves offers absolutely new strategies based on new combinations of various reported methods to enhance bladder functions and to recover some locomotion in paraplegics.

Laparoscopic management of endopelvic etiologies of pudendal pain in 134 consecutive patients.

PURPOSE: The feasibility of the laparoscopic transperitoneal approach to the pelvic somatic nerves was determined for the diagnosis and treatment of anogenital pain caused by pudendal and/or sacral nerve root lesions. MATERIALS AND METHODS: The records of 134 consecutive patients who underwent laparoscopy for refractory anogenital pain were retrospectively reviewed. All neurosurgical procedures, such as neurolysis/decompression of the pudendal nerve and the sacral nerve roots or neuroelectrode implantation to the sacral plexus for postoperative neuromodulation, were done via the laparoscopic transperitoneal approach to the pelvic nerves. RESULTS: A total of 18 patients had Alcock's canal syndrome and decompression was successful in 15. Due to failed decompression 3 patients underwent secondary sacral laparoscopic neuroprosthesis implantation with a decrease of at least 50% on the pain visual analog scale. Sacral plexus lesions or radiculopathies, most commonly postoperative lesions and retroperitoneal endometriosis, were found in 109 patients who underwent laparoscopic neurolysis of the sacral plexus. The final outcome depended on the etiology. Of patients with postoperative nerve damage 62% had a decrease in the mean +/- SD preoperative visual analog scale score of from 8.9 +/- 2.9 (range 7 to 10) to 2.4 +/- 2.3 points (range 0 to 4) at the time of article submission at a mean followup of 17 months (range 3 to 39). Because of failed decompression, 8 patients underwent secondary sacral laparoscopic neuroprosthesis implantation and a decrease in the pain visual analog scale score was achieved in 5. Of patients with an endometriosis lesion of the sacral plexus 78% had a decrease in the mean preoperative visual analog scale score of 8.7 +/- 1.9 (range 8 to 10) to 1.1 +/- 0.7 points (range 0 to 2) at the time of article submission at a mean followup of 21 months (range 2 to 42). All 6 patients with vascular entrapment of pelvic nerves achieved complete relief. The last 7 patients underwent primary sacral laparoscopic neuroprosthesis implantation with at least a 50% decrease in the pain visual analog scale score in 4. CONCLUSIONS: Our findings emphasize that in patients with seemingly inexplicable anogenital pain, especially after failed treatment for Alcock's canal syndrome, laparoscopic exploration of the pelvic nerves must be done for further diagnosis and therapy before prematurely labeling the patients as refractory to treatment.

Neuromodulation of the superior hypogastric plexus: a new option to treat bladder atonia secondary to radical pelvic surgery?

BACKGROUND: The aim of this study is to report on the impact of neuromodulation to the superior hypogastric plexus in patients with bladder atonia secondary to pelvic surgery. METHODS: In 4 consecutive patients with bladder atonia secondary to pelvic surgery, we performed a laparoscopic implantation of a neurostimulator--LION procedure--to the entire superior hypogastric plexus. RESULTS: Of the 4 reported patients, 3 are able to partially void or empty their bladder. CONCLUSIONS: If the presented results could be obtained in further patients and maintained in long-term follow-up, the LION procedure to the superior hypogastric plexus could change the management of bladder function in patients with bladder atonia.

The sacral LION procedure for recovery of bladder/rectum/sexual functions in paraplegic patients after explantation of a previous Finetech-Brindley controller.

STUDY OBJECTIVE: To report on our technique of sacral laparoscopic implantation of aneuroprosthesis-LION procedure-for recovery of bladder/intestinal/sexual function in paralyzed patients after spinal cord injury. DESIGN: Prospective case series report. SETTING: Academic community teaching hospital. PATIENTS: Eight consecutive complete T-paralyzed patients after explantation of a previous dorsal implanted Brindley-Finetech controller with a sacral deafferentation. INTERVENTIONS: Laparoscopic transperitoneal exposure of the sacral plexuse and bilateral implantation of Brindley-Finetech electrodes to the sacral nerve roots S2 to S4. MEASUREMENTS AND MAIN RESULTS: Feasibility, complications, and outcome of the procedures. In 6 patients, recovery of electrically induced micturition and defecation could be obtained and in 2 men recovery of electrically induced erection. In 2 other patients, exposure and intraoperative stimulation of the sacral nerve roots showed irreversible destruction of the motoric vesical and rectal nerves. In one, the bilateral implantation of neuromodulation electrodes permitted complete control of the spasticity of the lower limbs and to the autonomic dysreflexia. CONCLUSION: The laparoscopic transperitoneal approach offers minimally invasive access for implantation of electrodes to the sacral nerve roots in paralyzed patients for recovery of pelvic visceral functions after failure of a previous implanted dorsal Brindley-Finetech controller with sacral deafferentation.

The LANN technique to reduce postoperative functional morbidity in laparoscopic radical pelvic surgery.

BACKGROUND: We investigated the feasibility and advantages of introducing Laparoscopic Neuro-Navigation (LANN) into the field of laparoscopic gynecologic radical pelvic surgery. STUDY DESIGN: In a prospective pilot study, 261 consecutive patients underwent laparoscopic radical pelvic surgery for cervical cancer or deep infiltrating endometriosis of the parametria. During the procedure, dissection and electrostimulation, and consequently, sparing of the pelvic parasympathetic nerves by transection of the parametria, were performed. Postoperative bladder dysfunction was documented. RESULTS: Laparoscopic dissection and electrostimulation of the pelvic splanchnic nerves were feasible in all patients without any complications, and the rate of postoperative bladder dysfunction was considerably reduced, to less than 1% of the patients. CONCLUSIONS: The parasympathetic nerve-sparing method using the Laparoscopic Neuro-Navigation technique in laparoscopic radical pelvic gynecologic surgery is a feasible and reproducible technique that preserves postoperative bladder function.