Chancellor et al. 1999 USA
PEDro=5
RCT
N=57

Population: SCI with DESD (N=26) sphincterotomy (N=31) stent: Mean Age: 34.5 vs 39.1 yrs; Gender: males = 57; Level of injury: cervical = 70%, thoracic = 30%; Mean time since injury = 8.7 vs 8.0 yrs.
Treatment: Sphincterotomy vs placement of a sphincteric stent (UroLume prosthesis).
Outcome Measures: Urodynamic parameters (maximum detrusor pressure, bladder capacity, post-void residual urine volume), length of hospitalization. Collected pre-operatively and 3, 6, 12 and 24 months post-op.

• Significant ↓ in detrusor pressure (p<0.05) relative to baseline with both treatments and no difference between sphincterotomy and stent at any time.
• No significant change in bladder capacity with either treatment at any time.
• Significant ↓ in post-void residual volume (p<0.05) at some time points but not others – no difference between treatments.
• The need for catheterization, initially required in 50% of the sphincterotomy group and 71% of the stent group, was reduced to just 3, 4, 1, & 1 and 1, 0, 1 & 2 individuals respectively at each follow-up period.
• There was little difference in subjective assessment of impact of bladder function on quality of life or in the incidence of complications between the treatment groups.
• Those in the stent group spent less time in the hospital for the procedure (p=0.035).

Pan et al. 2009
Australia
Downs & Black score=21
Case series

• N=84

Population: Mean age=35.6yrs; Level of injury: quadriplegia=52, paraplegia=32.
Treatment: Charts of SCI patients that underwent external sphincterotomy were reviewed.

• Outcome Measures: Success or failure of sphincterotomy based on various clinical criteria. Mean follow-up of 6.35 years (1-20).

•  68% of patients had failure after initial sphincterotomy.
• UTI's were the most common reason for sphincterotomy failures followed by DSD and upper tract dilation.
• After a second sphincterotomy, 43% of patients reported success.

Seoane-Rodriguez et al. 2007
Spain
Downs & Black score=21
Case series
N=47

Population: SCI with overactive bladder with DESD: Mean age = 52.7 yrs; Gender: males = 47; Level of injury: cervical=68%, dorsal=23%, lumbar=9%; Severity of injury: AIS A: A=76.7%, B=9.3%, C=14%.
Treatment: Retrospective review of insertion of intraurethral stent (Memokath or UroLome).
Outcome Measures: Detrusor pressure, number of UTIs, autonomic dysreflexia, complications in the upper urinary tract, and prosthesis complications with average follow-up of 67 months (14-125).

• There was a significant decrease in detrusor pressure in most patients, p=0.0001.
• Post void residual volumes decreased 224cc, p=0.001.
• The presence of UTI diminished by 25% from 67.5 to 42.5%, p=0.031.
• The episodes of dysreflexia also decreased significantly (p=0.039).
• Upper urinary tract complications decreased from 47 to 23% (p=0.013).
• After stent placement, 84% of people that used indwelling catheter previously were able to manage with the external drainage.
• The most common complication for prosthesis placement was migration, 28%.
• 8.5% required stent removal.

Patki et al. 2006
UK
Downs & Black score=20
Case series
N=9

Population: SCI with urodynamic stress incontinence; Mean age = 38.2 yrs; Gender: males = 9; Level of injury: cervical = 1, lumbar = 3, thoracic = 5; Severity of injury: complete = 7, incomplete = 2.
Treatment: Artificial urinary sphincter (American Medical System 800) implantation with the urethral cuff around the bulbar urethra via a perineal approach. These require activation which occurred 6 weeks post-implantation. 
Outcome Measures: Continence rate, adverse effects, detrusor pressure, and bladder capacity. Follow-up in outpatient clinics at 3 months, 6 months, and yearly for a mean of 70.2 months (3-133 months).

• On date of activation there was a 100% continence rate and no patient reported leakage.
• Two patients reported significant recurrrent incontinence at 3 month follow up, with one implant being removed and the other being revised.
• At the end of 24 months, a scrotal pump of another patient become infected and was removed.
• Overall 57% of the successful implants have had no revisions and have the original implant at a mean follow-up of 105.2 months.
• No upper tract change or deterioration in renal function was noted in any patient.
• More than half of the patients with working implants recorded higher maximum detrusor pressures at followup.
• No significant changes were seen in bladder capacity.

Abdill et al. 1994
USA
Downs & Black score=19
Pre-Post
N=25

Population: SCI with DESD; Mean age = 32.8 yrs; Gender: males = 25; Level of injury: paraplegic = 2, tetraplegic = 23; Mean time since injury = 7.2 yrs.
Treatment: Surgical insertion of a wire mesh stent (UroLume).
Outcome Measures: Bladder capacity, residual urine volume, and voiding pressure.  Measures were taken at 1, 3, 6, and 12 months post operation.

• All subjects achieved spontaneous reflex voiding without incontinence and were managed with condom catheterization.
• Significant decrease was seen postoperatively in:
  • Voiding pressure (p<0.001).
  • Residual urine volume (p<0.01).
• No statistical difference was seen in bladder capacity after stent insertion.
• Complications included:
  • Hydronephorsis and reflux did not resolve in one patient and had to undergo bilateral urethral reimplantation which resulted in a urinary tract infection.
  • Migration of sphincter prosthesis was seen in 3 patients.

Chancellor et al. 1995
USA
Downs & Black score=18
Case series
N=41

Population: SCI with overactive bladder with DESD; Mean age = 35.7 yrs; Gender: males = 41; Level of injury: cervical = 34.
Treatment: Placement of a sphincter stent (UroLume). Several stent lengths were used: 2, 2.5, and 3 cm.
Outcome Measures: Voiding pressure, residual urine, and bladder capacity were measured at 3, 6, 12, and 24 months although other follow-up occurred up to 44 month (mean 18 months).

• All subjects achieved spontaneous reflex voiding without incontinence.
• Voiding pressures significantly decreased from 77cmH2O preoperatively to 35cmH2O at 12 months and 33cmH2O at 24 months after stent insertion (p=0.001).
• Post-void residual urinary volume decreased from 202 ml preinsertion to 64ml at 24 months, (p=0.001) postinsertion.
• No significant difference was seen in maxiumum cystometric capacity before and after insertion.
• No significant changes in any of the urodynamic parameters were seen after 24 months of follow up between patients with and those without previous external sphincterotomy.
• Hemorrhage requiring blood transfusion, obstructive hyperplastic epithelial overgrowth, stent encrustation or stone formation, nor soft tissue erosion occurred in any patients.
• Erectile function was not affected.
• Complete stent epithelialization was seen in 82% of patients in just 6 months.
• Stent repositioning or removal was required in 3 patients in the first month and 2 patients in one year.

Perkash 2007
USA
Downs & Black score=17
Case series
N=46

Population: Mean age=47.7yrs; Gender: males=46; Level of injury: quadriplegia=31, paraplegia=15; Severity of injury: AIS A&B=43 ,C=3
Treatment: SCI patients that underwent transurethral sphincterotomy were followed.
Outcome Measures: Post void residual urine, systolic BP, diastolic BP. Mean follow-up for 5.4±3.1 years (1-20).

•  Mean post void residual urine and systolic and diastolic BP decreased significantly post TURS (p<0.0001).
• After 1 year, only 4 patients still exhibited AD.

Mehta & Tophill 2006
UK
Downs & Black score=16
Pre-Post
29

Population: SCI with DESD; Mean age = 45 yrs; Gender: males = 29; Level of injury: paraplegic = 12, tetraplegic = 17; Time since injury = 12.8 yrs.
Treatment: Memokath stents were placed in men with suprasacral spinal cord injury.
Outcome Measures: Effectiveness, complications. Mean follow-up of 21 months (0-47 months).

• Initially all patients found memokath to be effective in preventing incontinence..
• At the last follow-up, 30 of 33 stents had been removed and 23 of these were due to complications.
• The most common causes of stent removal included:
  • Persistent haematuria in 3 patients.
  • UTIs in 4 (early) and 6 (later).
  • Acute retention in 2.
  • Migration in 7.
  • Stent blockage by encrustation or prostatic in growth in 14.

Game et al. 2008
France
Downs & Black score=15
Case series
N=147

Population: Mean age=41.3yrs; Gender: males; Type/Level of injury: quadriplegia=85, paraplegia=24, MS=24
Treatment: Charts of patients that underwent temporary urethral sphincter stent placement for neurogenic DSD.
Outcome Measures: UTI, post voiding residual volume, autonomic hyperreflexia with patients reviewed at 1 and 3 months post-placement and every 3 months thereafter.

• The most common early and late postoperative complication was urinary tract infection.
• After stent placement:
  • Significant reduction in post-voiding residual volume was seen (p<0.0001).
  • Number of patients experiencing symptoms of autonomic hyperreflexia decreased significantly (p=0.0003).
  • Significantly lower mean number of episodes of symptomatic urinrary tract infection was seen, p<0.0001).
• No signficant difference in outcome was noted between the Nissenkorn and Diabolo stent.
• Removal of stent did not result in any complications.
• 92 of the 147 patients had permanent urethral sphincter stent placed after removal of the temporary.

Chancellor et al. 1993a
USA
Downs & Black score=15
Pre-post
N=25

Population: SCI: Mean age = 32.8 yrs; Gender: males = 25; Level of injury: paraplegia = 2, tetraplegia = 23; Mean time since injury = 7.2 yrs.
Treatment: Insertion of a sphincteric stent (UroLome prosthesis).
Outcome Measures: Urodynamic parameters (voiding pressure, bladder capacity, post-void residual urine volume) and various complications. Collected pre-operatively and 3, 6, 12 months post-op.

• Significant ↓ in voiding pressure (p<0.001) relative to baseline at all follow-up times.
• No significant change in bladder capacity (p=0.57) at any follow-up time.
• Significant ↓ in post-void residual volume (p<0.01) at all follow-up times.
• Positive urine cultures (i.e., UTI) occurred in 22 of 25 patients prior to surgery but only in 9, 11 and 4 of the patients at 3, 6 and 12 months respectively.
• Subjective autonomic dysreflexia improved in all 19 who had previously complained of this.
• Pre-existing hydronephrosis in 5 patients resolved in 4.

Chancellor et al. 1993b USA
Downs & Black score=15
Pre-post
N=17

Population: MS (N=1), SCI (N=16): Mean age = 34.7 yrs; Gender: males = 17; Level of injury: paraplegia = 4, tetraplegia = 13; Mean time since injury = 13 yrs.
Treatment: Transurethral balloon dilation of external urinary sphincter.
Outcome Measures: Urodynamic parameters (voiding pressure, bladder capacity, post-void residual urine volume), cystoscopy, UTIs, autonomic dysreflexia and monitoring of renal and erectile function. Collected prior and 3, 6, 12 months post procedure.

• Of all 17 patients previously managed by indwelling Foley catheter, 15 now used condom catheters and 2 voided on their own.
• Significant ↓ in voiding pressure (p=0.008) relative to baseline at all follow-up times.
• No change in bladder capacity (p=0.30) at any follow-up time.
• Significant ↓ in post-void residual volume (p<0.05) at all follow-up times.
• +ive urine cultures (i.e., UTI) in 15/17 prior to surgery but only in 5, 8 and 4 of the patients at 3, 6 and 12 months respectively.
• Subjective autonomic dysreflexia improved in all 9 who had previously complained of this.
• Pre-existing hydronephrosis in 2 resolved.
• 3 had subjectively improved erectile function.
• Post-procedural complications included bleeding (1), development of new obstructions (2), stricture (1).

Juma et al. 1995
USA
Downs & Black score=6
Case Series
N=63

Population: SCI: Mean age = 53 yrs; Level of injury: cervical = 32, thoracic = 25, lumbar = 6; Severity of injury: complete = 32, incomplete = 32; Mean time since injury = 27 yrs; Mean follow-up since last sphincterotomy = 11 yrs; Mean # of sphincterotomies = 1.74.
Treatment: Follow-up evaluation of those having sphincterotomy.
Outcome Measures: Complications since sphincterotomy as determined by following: urinalysis, urine culture (UTI), urea, creatine levels, IVP, renal ultrasound, urodynamics, cystoscopy and voiding cystorethrogram (as indicated). Collected at follow-up at mean of 11 (2-30) years since last sphincterotomy.

• No statistical comparisons reported
  • 25/63 had upper tract pathology (12 renal calculi, 11 renal scarring, 1 atrophic kidney, 1 renal cyst). 19 of these were deemed significant.
  • Risk of significant upper tract complications in presence or absence of bacteria was 38% and 13% respectively.
  • 30/63 had lower tract complications (5 bladder calculi, 10 recurrent UTI, 3 urethral diverticula, 6 urethral stricture or bladder neck stenosis and 6 recurrent epididymitis).
  • Risk for lower tract complications ↑ with ↑ in leak point pressure; 50% for those with leak point pressure of > 70 cm H2O; reduced to 25% when leak point pressure of < 30 cm H2O.
  • Mean post-void residual remained high (496 ml).