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Author Year; Country
Score
Research Design
Total Sample Size
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Methods
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Outcome
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Binnie et al. 1991; UK
Downs & Black = 8
Prospective Controlled Trial
N=27
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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
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- 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).
- Paraplegics in stimulator group had a significant increase in defecation frequency compared to the SCI group.
- There was a non-significant trend towards a more rapid CTT in the stimulator group compared to the SCI group.
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Holzer et al. 2007
Austria
Downs & Black = 17
Pre-Post
N = 36
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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
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- 29 subjects demonstrated positive results during acute testing and underwent permanent implantation
- The median number of incontinence episodes decreased from 7 (range 4-15) to 2 (range 0-5) in 21 days
- There were statistically significant improvements in maximum resting pressure and maximum squeeze pressure after 12 and 24 months.
- There was significant improvement in QoL for subjects who underwent permanent implantation
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Gstaltner et al. 2008;
Austria
Downs & Black = 16
Pre-Post
N = 11
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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
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- Improved faecal continence in all 5 subjects
- Reported perianal sensitivity and improved deliberate retention of faeces in all 5 subjects
- Reported improved quality of life in all 5 subjects
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Valles et al. 2009
Spain
Downs & Black = 15
Pre-Post
N = 18
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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)
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- 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)
- 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.
- 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.
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Lombardi et al. 2009;
Italy
Downs & Black score = 15
Case-series
N = 23
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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.
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- Both the constipation and fecal incontinence groups experienced significant improvements in the Wexner score, more evacuations per week, and reduced time per defecation.
- Both groups had a significant improvement in the mental and general health subscales of the SF-36
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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
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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)
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- Low-frequency electrical stimulation (20 Hz, 350 μs, 8mA) at S3 increased anal sphincter and rectal pressure
- 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.
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Chia et al. 1996; Singapore
Downs & Black = 14
Pre-post
N=8
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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
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- 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.
- Six individuals with improved bowel routine also showed a positive rectoanal pressure difference after immediately after stimulation.
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Jarrett et al. 2005
USA
Downs & Black = 13
Pre-Post
N = 12
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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
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- 12 subjects demonstrated positive results and underwent permanent implantation
- Mean frequency of incontinence decreased from 9.33+7.64 episodes per week at baseline to 2.39+3.69 at last follow up
- ASCRS QoL coping score significantly improved; the SF-36 QoL scores did not change
- Neither resting nor squeeze anal canal pressure changed significantly compared to baseline
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Kachourbos & Creasey 2000; USA
Downs & Black = 12
Pre-post
N= 16
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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
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- Bowel program times were reduced from a mean of 5.4 hours per week pre-operatively to 2.0 hours per week post-operatively
- Autonomic dysreflexia due to bowel was eliminated
- 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
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MacDonagh et al. 1990; UK
Downs & Black =10
Pre-post
N=12
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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
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- 6 patients achieved full defecation with implant and manual help no longer required.
- time taken to complete defecation was reduced
- All were free from constipation
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