|Rasmussen et al 2015a
|Population: N=277 (145M, 132F)
Median (range) age 49 (19-80)
Median (range) time from SCI to SARS surgery 10 (0-49) years
Median (range) time from SARS surgery to follow-up 13 (1-25) years
131 cervical, 143 thoracic, 3 lumbar
Treatment: SARS implantation
Outcome Measures: 1-10 visual analog scale (VAS) questionnaire on SARS satisfaction and bowel dysfunction, NBD score, St. Marks fecal incontinence score, Cleveland constipation score
|1. Median (range) overall satisfaction with SARS 10 (0-10)
2. Significant changes before and after SARS in median (range) of:
Overall severity of bowel symptoms:
6 (4-8) to 4 (2-6)
17 (11-21) to 11 (9-15)
St. Marks score:
4 (0-7) to 4 (0-5)
7 (6-10) to 6 (4-8)
3. Lower total dependence on assistance, use of suppositories, digital evacuation, and mini enemas after SARS
|Chen & Liao 2015
Retrospective case series
N=23 (17M, 6F) with spinal cord injury or disease underwent SNM testing (7-28 days):
Mean (SD) age 37.3 (2.9)
Mean (SD) time since onset 15.5 (3.6) years
9 SCI, 9 myelomeningocele
2 complete, 21 incomplete
N=13 (10M, 3F) of which underwent permanent SNM implantation:
Mean (SD) age 34.1 (3.2)
Mean (SD) time since onset 14.4 (4.8) years
Treatment: Sacral neuromodulation (SNM)
Outcome measures: Constipation (Wexner score) and bladder measures
|1. 75.0% rate of improvement for constipation during testing
2. After implantation, 12/13 experienced improvement in constipation; 11 of which experienced ≥50% improvement
3. Loss of effect on constipation in 1 patient at 3 months post implantation
4. Significant reduction in Wexner score (for those with urinary incontinence; N=9) from baseline to testing phase and from baseline to follow-up (17.5±2.0 months after implantation) stage
|Lombardi et al. 2011;
|Population: 75 males with incomplete SCI who received permanent SNM implantation; Age:18-75yrs; year post injury>6 months; suffering from neurogenic bowel symptoms (NBS), neurogenic lower urinary tract symptoms, and/or neurogenic erectile dysfunction refractory to conservative management
Treatment: Sacral neuromodulation implantation (Medtronic, Inc)
Stage 1- electrode inserted percutaneously in third sacral foramina.
Stage 2- Permanent implantable pulse generator implanted in patient’s buttock only if main symptoms improved by at least 50% during phase 1.
Follow-ups scheduled at 1, 3, 6 months post implantation, and subsequently every 6 months
Outcome Measures: SF-36 health survey questionnaire; number of fecal incontinence episodes per week; number of evacuations per week and Wexner score (severity of fecal incontinence)
|1. Mean follow-up period from SNM permanent implantation to final visit was 53 months.
2. Patients presenting with NBS improved all parameters by at least 50% compared with baseline for mean (SD) number of occurrence of fecal incontinence (4.33 (1.66) vs 1.25 (1.17)); days with pads (4.5 (1.51) vs 1.33 (1.16)) and Wexner scores (13.66 (1.50) vs 5.83 (0.98)) per week at baseline vs final visit.
3. A significant improvement (20%) in SF-36 scores for all patients compared with baseline.
4. 11 adverse reactions were reported (5 individuals required change in stimulation sensation, 2 experienced loss of efficacy, 1 reported pain per leg spasticity, 2 reported pain at implanted pulse generator site, 1 reported adverse change in bowel function.
|Sievert et al. 2010;
N SCI treated with SNM= 10
|Population: 16 males with complete traumatic SCI (>T12, AIS A); 10 in treatment group, 6 controls; mean age 31 (range 19-47)
Treatment: Implanted with tined lead electrode/sacral nerve modulator (SNM) at third sacral foramen.
Controls: Prescribed oral antimuscarinics.
Outcome Measures: Participants provided bladder, bowel and erectile function diaries and answered questionnaires including laxative use
|1. SNM group reported they felt there was sufficient SMN colon movement without oral laxatives
2. SNM group has improved bowel movement control (incontinence events decreased)
3. All SNM participants reported significantly better quality of life than the controls. The specific SCI questionnaire used was not mentioned and no scores were given.
4. No intra- or post-operative complications were reported for the implant participants.
|Lombardi et al. 2009;
N = 23
|Population: 15M 8F; 2 cervical, 9 thoracic, 13 lumbar; mean (SD) age = 36(9) years; 12 participants had constipation (C), 11 had fecal incontinence (FI).
Treatment: sacral neuromodulation – unilateral implantation in the foramen sacral S3 root
Outcome Measures: Wexner questionnaire, SF-36, number of fecal evacuations per week, time per defecation.
|1. Mean time from neurological diagnosis to SNM therapy was 41 months (range 18-96). Mean follow-up time from SNM implantation to final visit was 44.3 months (range 18-96).
2. Both the constipation and fecal incontinence groups experienced significant improvements in the:
C group: pre-SNM=19.91, post-SNM final visit=6.82
FI group: pre-SNM=13.09, post-SMN final visit=4.91
-had increased evacuations per week: C group: pre-SNM=1.65, post-SNM final visit=4.98
– had decreased number of fecal incontinence per week
FI group: pre-SNM=4.55, post-SMN final visit=1.32
– reduced time per defecation:
C group: pre-SNM=45.85, post-SNM final visit=11.67 min.
– had a decreased number of pads used/day fecal incontinence: pre-SNM=2.36, post-SMN final visit=0.95
3. Both groups had a significant improvement in the mental and general health subscales of the SF-36.
4. A total of 1038 months yielded 12 adverse events in 5 patients: 4 related to pain at generator site, 3 to spasticity pain in lower limbs, 1 to excessive tingling in vaginal area, and 4 for battery changes.
|Valles et al. 2009;
N = 18
|Population: 9M 9 F; 4 cervical, 13 thoracic, 1 lumbar; AIS: 14 A, 1 B, 3 C; mean age 39 (range 18-63)yrs,
Treatment: Sacral anterior root stimulator, follow up from 12-21 months post implantation
Outcome Measures: Use of laxatives, number of bowel evacuation methods used, frequency of and time dedicated to bowel movements, prevalence of constipation, Wexner questionnaire
|1. After implantation, fewer patients took laxatives (10 vs. 13) and patients used significantly less methods to evacuate bowel (1.5 vs. 2.1)
2. The frequency of bowel movements significantly increased (10 vs. 6 participants had bowel movements every day), and time dedicated decreased (11 vs. 9 participants dedicated <30min) but was not significant.
3. Prevalence of constipation significantly decreased (7 vs. 11); episodes of fecal incontinence increased (18 vs. 16) and the mean Wexner score decreased (4.6 vs. 5.2) but these results were not significant.
|Gstaltner et al. 2008;
N = 11
|Population: Cauda equine syndrome with flaccid paresis of the anal sphincter muscle and fecal incontinence
Treatment: Participants underwent percutaneous nerve evaluation (PNE); following this analysis, a period of external temporary sacral nerve stimulation was performed in the both sides of the S2 or S3, and if the patient showed improvements in outcome measures, a permanent stimulator was implanted (N=5)
Outcome Measures: Wexner questionnaire, participants’ subjective perceptions of quality of life determined through interview.
|1. Improved fecal continence in all 5 participants (median score of Wexner score decreased from pre-SNS (15 (9-19)) to post-SNS (5(2-9)).
2. Reported perianal sensitivity and deliberate retention of feces improved in all 5 participants.
3. Reported improved quality of life in all 5 participants.
4. One complication was reported – one patient had minimal leakage of cerebrospinal fluid following the PNE, after removal of the needle, no further symptoms were reported.
|Holzer et al. 2007;
N = 36
|Population: 17 participants with SCI from spinal cord surgery, 11 from spinal cord trauma, 4 from meningomyelocele; 14M 22F; median age 49 (range 10-79) yrs.
Treatment: Sacral nerve stimulation in the sacral foramina S2-S4; follow up after 12 and 24 months for those who underwent permanent implantation after initial evaluation (N=29)
Outcome Measures: Number of incontinence episodes, maximum resting and squeeze anal canal pressure, American Society of Colorectal Surgeons (ASCRS) Quality of Life questionnaire
|1. Median number of incontinence episodes decreased from 7 (range 4-15) to 2 (range 0-5) in 21 days
2. There were statistically significant improvements in maximum resting and squeeze anal pressure after 12 and 24 months.
3. There was significant improvement in the ASCRS Quality of Life questionnaire for participants who underwent permanent implantation
|Jarrett et al. 2005;
N = 12
|Population: 6 participants with SCI from disc prolapse, 4 from trauma, and 1 from spinal stenosis; 4M 9F; median age 58yrs (range 39-73). Exclusion criteria: paraplegia.
Treatment: Temporary sacral nerve stimulation, permanent implant if subject demonstrated positive results, median follow up is 12 months (range 6-24)
Outcome Measures: Frequency of incontinence; resting and squeeze anal canal pressure ASCRS QoL questionnaire; SF-36 quality of life questionnaire
|1. 12 participants demonstrated positive results and underwent permanent implantation
2. Mean (SD) frequency of incontinence decreased from 9.33 (7.64) episodes per week at baseline to 2.39 (3.69) at last follow up
3. ASCRS QoL coping score significantly improved; the SF-36 QoL scores did not change
4. Neither resting nor squeeze anal canal pressure changed significantly compared to baseline
|Johnston et al. 2005;
N=3 (2 had neurogenic bowel outcome measures, results presented for 1)
|Population: Age: 17-21yrs; all with motor-complete thoracic SCI (T3-T8) of 1-1.5 years duration.
Treatment: All participants received implantation of epineural electrodes for skeletal muscle stimulation for upright mobility. 2 participants also received additional extradural electrodes (S2,3,4) for bowel and bladder management. Stimulation was conducted via 22 channel implanted Praxis FES system.
Outcome Measures: Rectum and anal sphincter local pressures, patient self-report diary wherein he described the quantity of stool passed during each daily session, the time spent, and a numerical ‘satisfaction’ rating from 1 (least satisfied) to 10 (most satisfied)
|1. Low-frequency electrical stimulation (20 Hz, 350 μs, 8mA) at S3 increased anal sphincter and rectal pressure
2. Over a 2-month period, daily use of electrical stimulation appeared to provide a significant improvement in bowel management, causing an increased frequency of defecation, a decrease in time required for bowel evacuation (from 52 min to 23 min), and improved satisfaction over non-stimulation evacuation methods. 2 stimulation strategies were used by the patients: 1) low-freq stim. for 30s on, 30s off for 5-10 min; 2) 5-10 min of low-freq. stim followed by 5 min of low/high freq. combination stim.
|Kachourbos & Creasey 2000;
|Population: Adults with SCI (demographics not reported) and a history of bowel complications
Treatment: Implantation of sacral roots electrodes (S1-S3) with rhizotomy at the conus medularis. Stimulation was delivered via use of VOCARE Bladder and Bowel Control System (Finetech-Brindley stimulator).
Outcome Measures: Bowel program times; occurrence of autonomic dysreflexia due to bowel movement; quality of life regarding dependence, socialization, sense of control, and overall quality of life
|1. Bowel program times were reduced from a mean of 5.4 hours per week pre-operatively to 2.0 hours per week post-operatively.
2. Autonomic dysreflexia due to bowel movements was eliminated.
3. Users reported a greater sense of independence, increased socialization, greater control over their lives, improved self-image, decreased feelings of depression, improved interpersonal relationships and an overall improvement in quality of life.
|Chia et al. 1996;
|Population: Level of injury: 4 C4-C6, 4 T3-T11; 6M: 2F; Age: mean 40, range 20-53yrs. All participants suffered from severe constipation (≤2 bowel movements/week and/or straining at stool for >25% of the time)
Treatment: Anterior sacral roots electrodes (S2,3,4) implanted for electrical stimulation.
Outcome Measures: Bowel frequency, laxative use, suppository use, need for digital evacuation, anorectal monometry
|1. 6/8 patients had improvement in bowel function: 4/6 were able to evacuate spontaneously after stimulation, 1 described digital evacuation as “easier,” 1 used an occasional suppository without the need to digitally evacuate.
2. Six participants with improved bowel routine also showed increased rectoanal pressure immediately after stimulation.
|Binnie et al. 1991;
Prospective Controlled Trial
|Population: 3 groups:
1) a control group of 10 healthy volunteers (8M 2F; mean age: 29.1)
2) 10 SCI participants without the Brindley implant (9M 1F; C4-T10; mean age: 34.1; mean DOI: 8.1 yrs)
3) 7 SCI participants with implanted Brindley implant (6M 1F; C5-T3; mean age: 36.3; mean DOI: 7.4 yrs; mean time since implant: 2.6 yrs)Treatment Brindley anterior sacral root stimulator implantOutcome Measures: Oro-caecal and oro-anal transit time, fecal water content, and frequency of defecation
|1. There was no significant difference in mean (SEM) oro-caecal times between the AB group (2.95 (0.15) hrs) and the SCI group (3.4 (0.34) hrs) or between the AB group and the Brindley stimulator group (3.4 (0.34)).
2. Paraplegics in stimulator group (0.78 (SEM=0.08) days) had a significant increase in defecation frequency compared to the SCI control group (0.37 (0.07)).
3. There was a non-significant trend towards a more rapid CTT in the stimulator group compared to the SCI group.
|MacDonagh et al. 1990;
|Population: Complete supraconal spinal cord lesions, 9M 3F, mean age: 33 (range: 21-49), 10 thoracic, 2 cervical, > 2 years post-injury
Treatment: Brindley-Finetech intradural sacral anterior root stimulator implant
Outcome Measures: full defecation
|1. 6 patients achieved full defecation with implant and manual help was no longer required.
2. Time taken to complete defecation was reduced.
3. All were free from constipation.