Bowel Management Table 5b Implanted Electrical Stimulation Systems

Author Year; Country
Score
Research Design
Total Sample Size

Methods

Outcome

Binnie et al. 1991; UK
Downs & Black = 8
Prospective Controlled Trial
N=27

Population: 2 groups: 7 subjects with implanted stimulator; 10 subjects without implant, Age range=20-50 years; C3-T10; time since injury range=1-21 years.
Treatment: comparing individuals with SCI with a Brindley anterior sacral root stimulator implant to individuals with SCI without the implant
Outcome Measures: Oro-caecal and oro-anal transit time, fecal water content, and frequency of defecation

  1. There was no significant difference between the oro-caecal times for the controls and the SCI group or between the controls and the Brindley stimulator group (p>0.05).
  2. Paraplegics in stimulator group had a significant increase in defecation frequency compared to the SCI group.
  3. There was a non-significant trend towards a more rapid CTT in the stimulator group compared to the SCI group.

Holzer et al. 2007
Austria
Downs & Black = 17
Pre-Post
N = 36

Population: 36 subjects, 22 female, 14 male; 17 subjects with spinal cord surgery, 11 with  spinal cord trauma, and 4 with meningomyelocele; median age 49 (range 10-79) years.
Treatment: Sacral nerve stimulation (SNS), follow up after 12 and 24 months
Outcome Measures: Number of incontinence episodes, maximum resting and squeeze anal canal pressure, American Society of Colorectal Surgeons (ASCRS) Quality of Life questionnaire

  1. 29 subjects demonstrated positive results during acute testing and underwent permanent implantation
  2. The median number of incontinence episodes decreased from 7 (range 4-15) to 2 (range 0-5) in 21 days
  3. There were statistically significant improvements in maximum resting pressure and maximum squeeze pressure after 12 and 24 months.
  4. There was significant improvement in QoL for subjects who underwent permanent implantation

Gstaltner et al. 2008;
Austria
Downs & Black = 16
Pre-Post
N = 11

Population: Total of 11 patients suffering from flaccid paresis of the anal sphincter  muscle and faecal incontinence caused by cauda equina syndrome underwent percutaneous nerve evaluation; eventually 5 proceeded to permanent implantation of sacral nerve stimulation (SNS) system
Treatment: Patients underwent percutaneous nerve evaluation (PNE); following this analysis, a period of external temporary SNS was performed, and if the patient showed improvements, a permanent SNS system was implanted
Outcome Measures: Wexner score (severity of fecal incontinence); subject’s subjective perceptions of quality of life, determined through interview

  1. Improved faecal continence in all 5 subjects
  2. Reported perianal sensitivity and improved deliberate retention of faeces in all 5 subjects
  3. Reported improved quality of life in all 5 subjects

Valles et al. 2009
Spain
Downs & Black = 15
Pre-Post
N = 18

Population: 18 subjects with SCIs, 9 men 9 women, mean age 39 (range 18-63) years, 4 subjects with cervical injuries, 13 with thoracic, and 1 with lumbar lesions; 14 subjects with AIS-A, 1 with AIS-B, and 3 with AIS-C
Treatment: Sacral anterior root stimulator, follow up from 12 to 21 months post implantation
Outcome Measures: Use of laxatives; number of bowel evacuation methods used; frequency of and time dedicated to bowel movements; constipation; the Wexner score (severity of fecal incontinence)

  1. After implantation, fewer patients took laxatives (10 vs. 13) and patients used significantly less methods to evacuate bowel (1.5 vs. 2.1) (p<0.05)
  2. The frequency of bowel movements significantly increased (10 vs. 6 subjects had bowel movements every day) (p<0.05), and time dedicated to bowel movement decreased (11 vs. 9 subjects dedicated <30min) but was not significant.
  3. Constipation significantly decreased (7 vs. 11) (p<0.05); incidence of fecal incontinence increased (18 vs. 16) but the mean Wexner score decreased (4.6 vs. 5.2) but were not significant.

Lombardi et al. 2009;
Italy
Downs & Black score = 15
Case-series
N = 23

Population: Mean age = 36±9 years; 15 male; 2 subjects with cervical injuries, 9 with thoracic injuries; 13 with lumbar injuries; 12 subjects had constipation, 11 had fecal incontinence.
Treatment: sacral neuromodulation
Outcome Measures: Wexner questionnaire, SF-36, number of evacuations per week, time per defecation.

  1. Both the constipation and fecal incontinence groups experienced significant improvements in the Wexner score, more evacuations per week, and reduced time per defecation.
  2. Both groups had a significant improvement in the mental and general health subscales of the SF-36

Johnston et al. 2005; USA
Downs & Black = 14
Pre-post
N=3; however, only 2 had neurogenic bowel outcome measures and results presented only for 1

Population: 3 subjects; ages from 17 to 21; all sustained motor-complete thoracic SCI (T3-T8) of 1-1.5 years duration.
Treatment: All subjects received implantation of pineural electrodes for skeletal muscle stimulation for upright mobility. 2 subjects also received additional extradural electrodes (S2,3,4) for bowel and bladder management. Stimulation was conduced via 22 channel implanted Praxis FES system.
Outcome Measures: Rectum and anal sphincter local pressures, patient 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.

Chia et al. 1996; Singapore
Downs & Black = 14
Pre-post
N=8

Population: 6 males and 2 females; mean age 40 (range 20-53) years; level of injury: 4 with cervical (C4-C6) injuries and 4 with thoracic (T3-T11) injuries. All patients suffered from severe constipation (≤2 bowel movements/week and/or straining at stool for more than 25% of the time)
Treatment: All patients had 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 of 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 individuals with improved bowel routine also showed a positive rectoanal pressure difference after immediately after stimulation.

Jarrett et al. 2005
USA
Downs & Black = 13
Pre-Post
N = 12

Population: 6 subjects with disc prolapse, 4 with  trauma, and 1sibject with spinal stenosis ; 9 women, 4 men; median age 58 (range 39-73)
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 subjects demonstrated positive results and underwent permanent implantation
  2. Mean 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

Kachourbos & Creasey 2000; USA
Downs & Black = 12
Pre-post
N= 16

Population: 16 adult patients with SCI 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; Quality of life regarding dependence, socialization, sense of control, and overall QOL

  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 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 QOL

MacDonagh et al. 1990; UK
Downs & Black =10
Pre-post
N=12

Population: 12 Patients with complete supraconal spinal cord lesions, > 2 years post-injury
Treatment: Implanted Brindley-Finetech intradural sacral anterior root stimulator
Outcome Measures: full defecation

    1. 6 patients achieved full defecation with implant and manual help no longer required.
    2. time taken to complete defecation was reduced
    3. All were free from constipation