Authors
Inclusion criteria
Exclusion criteria
Kenefick et al. [20]
Failed conventional therapy, bowel frequency 2 or less per week, straining > 25 % of time, minimum duration 1 year
Previous abdominal surgery, hysterectomy, current or planned pregnancy, significant psychological disturbance
Kamm et al. [21]
Failed conventional therapy, bowel frequency 2 or less per week, straining > 25 % of time, minimum duration 1 year
Previous large bowel surgery. Current or planned pregnancy, significant psychological disturbance. Presence of Stoma, rectal prolapse, congenital or organic bowel pathology. Alternating constipation and diarrhea
Malouf et al. [19]
Long-standing constipation with slow gut transit, failed conservative treatment (included biofeedback), Rome III criteria
Previous surgery for constipation. Significant psychological disturbance
Sherma et al. [36]
Failed conventional therapy (included rectal irrigation and biofeedback), bowel frequency 2 or less per week, straining > 25 % of time, minimum duration 1 year
Not described
Ganio et al. [32]
Feeling of incomplete evacuation for > 50 % of bowel movements during previous year. Failed conventional therapy
Sphincteric defect, current or planned pregnancy, inflammatory bowel disease, cardiac disease
Holzer et al. [33]
Failed conventional therapy, bowel frequency 2 or less per week, Severe constipation with pathologic colonic transit study
Congenital anorectal malformations, rectal prolapse, chronic bowel disease, presence of stoma, neurologic disease, bleeding complication
Carriero et al. [34]
Failed conventional therapy (included biofeedback and laxative), Rome III criteria
Symptoms of ODSa at defecography, previous abdominal surgery, congenital malformation, neurologic disease
Naldini et al. [35]
Failed conventional therapy, bowel frequency < 1 per week without laxative, minimum duration 1 year. Slow transit
ODS, anorectal dyssynergism, congenital anorectal malformation, external rectal prolapse. Current or planned pregnancy, significant psychological disturbance. Chronic inflammatory bowel disease
Humphreys et al. [37]
6 to 15 years old with presenting symptoms of dysfunctional voiding, enuresis, incontinence, urinary tract infections, bladder pain, urinary retention, urgency, frequency, constipation, and/or fecal soiling
Not described
Govaert et al. [38]
Failed conventional therapy, bowel frequency < 1 per week without laxative, minimum duration 1 year. Slow transit
Any organic pathology causing constipation, previous large bowel surgery, inflammatory bowel disease, erratic bowel habit (alternating constipation and diarrhea, or irritable bowel syndrome), congenital anorectal malformations, stoma in situ, neurologic diseases (such as complete spinal cord transection, multiple sclerosis, spina bifida, or Parkinson disease), Current or planned pregnancy, significant psychological disturbance
van Wunnik et al. [39]
10–18 years patients who fulfill Rome III criteria, failed conventional therapy
Organic pathology, chronic IBD, previous large bowel surgery, congenital anorectal malformations, or neurological disease (complete spinal cord transection, multiple sclerosis, or spina bifida). Current or planned pregnancy, significant psychological disturbance
Knowles et al. [26]
Failed conventional therapy. Failure to evacuate more than 60 % of instilled rectal contrast in 3 min using a standard defecography protocol. Absence of delayed colonic transit, megarectum or significant dynamic structural obstructions (rectocele and intussusception)
Congenital anorectal anomalies or absence of native rectum due to surgery; present evidence of external full-thickness rectal prolapse; stoma in situ; chronic bowel diseases such as inflammatory bowel disease. Current or planned pregnancy
14.3.2 Investigations
Preoperative investigations included in most of the studies a colonic transit studies, barium enema, colonoscopy, study of anorectal physiology, and defecography. All the preoperative assessments for each study are reported in Table 14.2.
Table 14.2
Investigations before sacral neuromodulation
Authors | Investigation before NMS | Additional Insights |
---|---|---|
Kenefick et al. [20] | Colonoscopy, proctography, transit study, anorectal physiology | Wexner constipation score, SF-36 quality of life assessment |
Kamm et al. [21] | Sigmoidoscopy, anorectal physiology, whole-gut transit study (before and 6 months after permanent implant) | Cleveland Clinic constipation score, SF-36, subjective questionnaire |
Sherma et al. [36] | Colonic visualization, anal physiology, colonic transit study, defecation proctogram | Not described |
Ganio et al. [32] | Barium enema/colonoscopy, anal ultrasound, anal manometry, pudendal nerve terminal motor latency, transit study, defecography | Not described |
Holzer et al. [33] | Clinical examination, colonoscopy, colonic transit study, defecography | Wexner constipation score, SF-36 quality of life assessment |
Carriero et al. [34] | Colonscopy, anorectal manometry, and endoanal ulrasound | Wexner constipation score, SF-36 quality of life assessment, MMPI-2 |
Naldini et al. [35] | Colonscopy, anorectal manometry and anal sphincter electromyography, colonic transit time, cysto-colpo defecography | Wexner constipation score, SF-36 Quality of life assessment |
Govaert et al. [38] | Physical examination, colonic transit time study, defecography, and anorectal physiology testing | Wexner constipation score, bowel habit diary |
van Wunnik et al. [39] | Whole-gut transit time study, defecography, MRI, anorectal manometry, rectal sensitivity | Bowel diary, Cleveland Clinic constipation score |
Knowles et al. [26] | Colonic transit study, defecography, anal manometry | Bowel diary, SF-36 quality of life assessment |
14.3.3 Clinical Predictors
Psychological evaluation has shown to be a significant predictive method for the selection of patients with constipation suitable for SNS treatment, reaching a success rate of 85 % [34].
Using MMPI, Wexner and colleagues found in constipated patients a significant elevation on the hypochondriasis and depression scales [40]. They concluded that constipated patients may benefit greatly by adding a psychological component to the treatment regime.
Another study carried out in 40 patients with ODS who underwent transanal rectal prolapsectomy, a recurrence of constipation occurred in 52 % of cases at a median follow-up of 3 years [41]. This decreased to 20 % when patients with psychoneurotic disorders were excluded, suggesting that the underestimated occult-associated disease, such as anxiety and depression, might be associated with a poor result.
In the study proposed by Carriero et al. [34], the essential role of psychological evaluation was confirmed when the results of the group of patients who were initially excluded due to their psychological conditions were added, causing a significant drop of the success rate and making it comparable to the lowest success rates reported in literature.
In another study, Martellucci and Naldini [42], performing a retrospective analysis of patients with STC with pathologic colonic transit time that underwent SNM test, evaluated the success of the treatment related to the preoperative bowel preparation protocols.
In their study, 20 patients underwent no preparation, 7 patients underwent to a preoperative enema, and 11 patients underwent to a complete preparation with sodium phosphate. Twenty-five patients (65 %) were definitively implanted: 12/20 (55 %) patients in the first group, 4/7 (57 %) in the second group, and 9/11 (82 %) in the third group underwent to definitive SNM, respectively, suggesting that preoperative bowel preparation could help to improve the results during the screening period of SNM for STC.
14.4 Efficacy
General results are included in Table 14.3.
Table 14.3
Results of published studies of sacral nerve stimulation for constipation in adult patients
Authors | Year | Study type | Tested | Permanent | % success | Selection |
---|---|---|---|---|---|---|
Kenefick et al. [20] | 2002 | Prospective | 10 | 4 | 40 | |
Malouf et al. [19] | ||||||
Holzer et al. [33] | 2008 | Prospective database | 19 | 8 | 42 | |
Kamm et al. [21] | 2010 | Prospective | 62 | 45 | 72.5 | |
Naldini et al. [35] | 2010 | Prospective database | 15 | 9 | 60 | |
Carriero et al. [34] | 2010 | Prospective database | 13 | 11 | 84.5 | MMPI test |
Sharma et al. [36] | 2011 | Prospective database | 21 | 11 | 52.5 | |
Govaert et al. [38] | 2012 | Prospective database | 117 | 68 | 58 | |
Knowles et al. [26] | 2012 | Double-blind crossover | 13 | 11 | 85 | Rectal hyposensitivity |
Ortiz et al. [43] | 2012 | Prospective database | 48 | 23 | 48 |
In the Malouf and Kenefick patients [18, 19], four of the ten tested patients demonstrated a successful increase of symptoms and where definitively implanted. An increase in the number of spontaneous defecations was demonstrated at 6-month follow-up. Improvement in the Cleveland Clinic constipation score was reported. Ganio et al. [32] described 40 patients with functional anorectal and urinary disturbances, of whom 12 had constipation. After 10 days of peripheral nerve evaluation (PNE), ten completed the course of stimulation. This group showed an improvement in initiating evacuation and a reduction of time required to evacuate. In the Naldini et al. [35] study, 15 patients with slow-transit constipation underwent temporary SNS. Of these, nine managed to have permanent implant. At 6 months, there was an increase in the number of bowel movements per week. In the Holzer et al. [33] prospective study, 19 patients underwent to temporary SNS. Eight of these had slow-transit constipation, and nine had evacuatory dysfunction. Eight patients (four with slow-transit and four with evacuatory dysfunction) undergone to permanent stimulation and it results in a reduction of Cleveland Clinic constipation scores and short form 36 (SF-36) quality of life (QoL) scores. Kamm et al. [21] in 2010 performed a multicenter prospective study with 62 patients underwent test stimulation of whom 45 (73%) progressed to permanent stimulation with a follow-up median of 28 months. Thirty-nine (87 %) of the 45 who had undergone permanent stimulation showed an improvement in frequency of defecation, straining, sensation of incomplete evacuation, abdominal pain, and bloating. There was an improvement of the Cleveland Clinic constipation score from 18 at baseline to 10. The colonic transit time in half of the patients with slow gut transit had normalized by 6 months. Govaert et al. [38] reviewed 117 patients who had undergone temporary test for SNS. Of these 68 proceeded to permanent SNS. Some of the patients in this report were part of the multicenter study published by Kamm et al. [21]. There was an initial significant improvement in the Cleveland Clinic constipation score from mean 17 to 10,2 at first follow-up, maintained at a 37 months. Sharma et al. [36] submitted 21 patients to temporary stimulation, 18 of whom had slow-transit constipation. Of these, 11 went on to have a permanent implant. Eight of these 11 patients stopped using laxatives. Carriero et al. [34] proposed a psychological assessment for the selection of patients. In this study, 68 patients with slow-transit constipation underwent Minnesota Multiphasic Personality Inventory (MMPI)-2 questionnaire, but only 45 completed the questionnaire. Thirteen had a normal score and underwent temporary screening phase. Of these, 11 proceeded to permanent stimulation. Interestingly, nine of the patients who had refused to complete the MMPI-2 questionnaire, or had an abnormal score, requested to be with tested despite the psychological evaluation results. Of these, only three (33 %) progressed to permanent stimulation.
In the prospective randomized double-blind placebo-controlled crossover trial of Knowels et al. [26], 14 female patients with proctographically defined evacuatory dysfunction (ED) and demonstrable rectal hyposensitivity were studied. In this study, 13 patients completed the trial, and 11 were definitively implanted. Defecatory desire volumes to rectal balloon distension were normalized in 10 patients and maximum tolerable volume in 9. There was a significant increase in the number of successful bowel movements per week and in the Cleveland Clinic constipation score. It has to be shown that after a follow-up of 19 months, only 9 patients still benefit from the treatment, partially influencing the good success rate.