Int J Colorectal Dis DOI 10.1007/s00384-014-1927-6
LETTER TO THE EDITOR
Outcomes of implementation of sacral nerve stimulation on urination, defecation, and sexual function in patients with spinal cord injury Abbas Norouzi Javidan & Klaus Mazel & Sahar Latifi & Mohammad Mohsen Maghari & Hooshang Saberi & Abolghasem Nikfalah & S. Adeleh Mirjafari Daryasari & Mir Saeed Yekaninejad
Accepted: 12 June 2014 # Springer-Verlag Berlin Heidelberg 2014
Dear Editor: Sacral nerve stimulation (SNS) is a minimally invasive surgical procedure which exerts chronic electrical stimulation of nerves in sacral plexus and influences organs which are innervated by these nerves [1]. The beneficial effect of sacral nerve stimulation (SNS) on bowel, bladder, and sexual function has been previously reported in patients with neurological deficit. However, this effect was not yet evaluated in spinal cord injury (SCI). Here, we investigated the outcomes of SNS in three patients who underwent implantation of permanent interStim lead in third sacral foramen. This report is the preliminary report of a phase one clinical trial in evaluating safety and efficacy of SNS implementation in patients with SCI. The selection process of patients included six stages before implanting the device and four episodes of follow-up after surgery. In the first stage, potentially suitable patients were screened and were referred by a colorectal surgeon. In stage two, patients were selected based on inclusion and exclusion criteria, and written consents were obtained after explaining adequate information. Inclusion criteria were (1) age between 18–50 years, (2) incomplete spinal cord lesion, (3) minimum post injury duration of 2 years, (4) existence of urination and A. N. Javidan : S. Latifi : M. M. Maghari (*) : H. Saberi : A. Nikfalah : S. A. M. Daryasari : M. S. Yekaninejad Brain and Spinal Injury Research Center (BASIR), Imam Khomeini Hospital, Tehran University of Medical Sciences, Keshavarz Boulevard, Gharib Street, PO box: 6114185, Tehran, Iran e-mail:
[email protected] M. M. Maghari e-mail:
[email protected] K. Mazel Department of Surgery, Friedrich-Alexander Universität Erlangen-Nürnberg, Erlangen, Bavaria, Germany
defecation incontinence as a consequence of spinal cord injury, (5) intact external sphincter and levator ani muscles (which is confirmed by physical examination accompanied by anal endosonography and/or MRI), (6) defecation frequency less than once a week and/or fecal incontinence, (7) existence of no other treatment options for patients with constipation or incontinence according to neurology and neurosurgery consultation, (8) existence of stable emotional status confirmed by psychiatry consult, (9) intertractable constipation (defecation less than twice a week or having difficulty in defecation with feeling incomplete evacuation in more than 25 % of attempts), (10) being completely conscious and well-informed by signing the consent form, and (11) being able to use hands in applying the device and recording defecation habits. Exclusion criteria were (1) complete pudendal nerve damage (confirmed by EMG/NCV), (2) history of inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS) (if necessary, mentioned IBD was ruled out by using colonoscopy), (3) pregnant patients or intention to become pregnant, (4) history of a congenital anorectal disorder, (5) mental retardation (confirmed by psychiatry consultation), (6) history of rectal prolapse or anterior resection, (7) active skin infection, bed sore, or existence of pilonidal cyst, and (8) non-repairable destruction of external sphincter and levator ani muscles. Before the patients were trained to perform biofeedback exercises, some investigations were performed including: anorectal manometry, urodynamic assessment, evaluation of life quality with SF-36 questionnaire, estimation of ‘Cleveland constipation score’ (CCS), estimation of sexual activity, and satisfaction with the International Index of Erectile Function (IIEF) questionnaire and Visual Analog Scale (VAS) (stage 3). In stage 4, biofeedback exercises of anal sphincter were explained and taught to patients and after 6 weeks the same tests and evaluations in stage 3 were performed (stage 5). In stage 6, test lead was
Int J Colorectal Dis
implanted and was connected to external generator and patient was admitted for 1 day. After 15–21 days, if peripheral nerve evaluation (PNE) was positive and no complete pudendal nerve damage was detected, patients were assessed with mentioned tests and questionnaires (except urodynamic assessment). In this stage, occurrence of complications of applied procedure was evaluated and also urine residue amount with ultrasound was determined. Permanent device was implanted maximum during 3 months after the test. In follow-up program, patients were evaluated with SF-36, CCS, and IIEF questionnaires along with Visual Analog Scale (VAS) after 1, 3, 6, and 12 months. Manometry was performed in these time intervals, and complications were assessed in each follow-up visit. Complications during operation such as anesthesia complications (existence of sensitivity to anesthetics medications, occurrence of nausea, vomiting, vocal cord damage, hemodynamic changes, etc.) and general complications (bleeding, coagulation complication and insufficiency, respiratory problems, vascular damage, heart and vascular complications, etc.) were assessed. After operation, the occurrence of following complications was assessed: local pain, metabolic disorders, bleeding, deep venous thrombosis (DVT), infection of surgery site, pulmonary embolism, spasms of involved plegic limbs, ICU admission, headache, hospital infection, systemic complications, pain in the site of permanent lead, movement and position change of generator, position change of the lead, infection of implanted device, generator or lead, technical errors of implanted device, urinary tract complications, gastrointestinal tract complications, paresthesia in generator site, and feeling of electrical shock. All the mentioned complications were listed in a form and were assessed after implementation of external generator and during each follow-up visits after implantation of SNS (1, 3, 6, 12, and 24 months after surgery). Anorectal manometry in all patients showed improved contractions with present rectoanal inhibitory reflex. All patients showed increased IIEF score. Satisfaction in urination, defecation, and sexual function was subjectively mentioned with visual analog scale (0–10). In patient 1, defecation score was increased from 0.5 to 6.2, while in patient 2 the most significant rise was observed in sexual ability score (from 0 to 4). Patient 3 had noticeable improvement in urination satisfaction score (from 5.4 to 7). Although increased satisfaction in defecation was observed, scores of CCS were raised which illustrates exacerbation of constipation The results of anorectal manometry in all three mentioned cases showed improvement of contraction and achievement a better anorectal function pattern. These results were in line with patients’ expression of satisfaction which was subjectively assessed. These results are in line with Kenefick [1] findings that showed the same achievement in non-SCI patients. Worsening of constipation in our study which was determined by increased score of CCS in all three cases shows that along with exacerbation of constipation, satisfaction in defecation process
is increased which suggests that this higher satisfaction is mainly obtained by improvement of other characteristics of defecation (such as incontinence). Consistent with Ripetti et al. [2] who revealed an increase in maximal squeeze pressure in manometries after SNS, same manometric results were obtained in our study in patients with SCI. This phenomenon can be due to contraction of pelvic floor and anal sphincter as a result of transformation of fast fatigable muscular fibers (type I) to fatigue-resistant (type II) fibers [3]. Our study showed that spinal cord injured men who were suffering from erectile dysfunction showed better sexual function after SNS implementation. The improvement of sexual function was determined by increased IIEF score and patients’ subjective expression of their satisfaction. Our results are in line with Fariello [4] who showed in a review article the positive effects of SNS on sexual function. Sacral nerve stimulation is mediated through a lead which is implanted at the S3 foramen. By this method, pelvic and pudendal nerves are stimulated and perineum muscles, which play an important role in bowel and bladder function, are stimulated as well, so the coincidental influence on bowel, bladder, and erectile function is expected. However, while all these components are known to participate in determining quality of life, we could not detect any significant changes in SF-36 scores. Only one of our patients reveled increased SF-36 total score (from 84 to 114) which was mostly exerted through increased score of mental component summary (especially energy and emotion). To our knowledge, this is the first study showing the beneficial effect of SNS on erectile function and improvements in satisfaction of bowel function and fecal incontinence in patients with SCI. Here, we have reported three patients with spinal cord injury, who underwent implantation of permanent InterStim stimulation to exert sacral nerve neuromodulation. Outcomes of anorectal manometry, urodynamics, and subjective assessments (CCS, IIEF, satisfaction score by VAS) showed higher satisfaction of urination, defecation, and sexual functions along with deteriorated constipation. QoL which was assessed by SF-36 questionnaire was not significantly changed. Conflict of interest None declared
References 1. Kenefick NJ (2006) Sacral nerve neuromodulation for the treatment of lower bowel motility disorders. Ann R Coll Surg Engl 88(7):617–23 2. Ripetti V, Caputo D, Ausania F, Esposito E, Bruni R, Arullani A (2002) Sacral nerve neuromodulation improves physical, psychological and social quality of life in patients with fecal incontinence. Tech Coloproctol 6(3):147–52 3. Tanagho EA (1993) Concepts of neuromodulation. Neurol Urodyn 12: 487–488 4. Fariello JY, Whitmore K (2010) Sacral neuromodulation stimulation for IC/PBS, chronic pelvic pain, and sexual dysfunction. Int Urogynecol J 21(12):1553–8
