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Sphincterotomy, Artificial Sphincters, Stents and Related Approaches for Bladder Emptying

Transtherurethral sphincterotomy and related procedures, such as insertion of artificial sphincters, sphincteric stents or balloon dilation of the external urinary sphincter, provide a means to overcome persistent dysynergia (Chancellor et al. 1999; Juma et al. 1995; Chancellor et al. 1993a; Chancellor et al. 1993b; Patki et al. 2006; Seoane-Rodriguez et al. 2007). Often these are performed when intermittent catheterization is not an option because of a lack of manual dexterity and when more conservative options have proven unsuccessful (Chancellor et al. 1999; Juma et al. 1995). With the success of transvaginal tape implantation in patients of non-neurogenic stress incontinence, Pannek et al. (2012) sought to evaluate its use for neurogenic stress incontinence in females with SCI but results were unfavourable.

Table 19 Sphincterotomy, Intraurethral Stent Insertion and Related Approaches for Bladder Emptying

Author Year

Country
Research Design
Score
Total Sample Size

MethodsOutcome
Chancellor et al. 1999 USA

RCT

PEDro=5
N=57

Population: SCI with detrusor-external sphincter dyssynergia=26, sphincterotomy=31: Mean age: 34.5 yr versus 39.1 yr; Gender: males=57; Level of injury: cervical=40, thoracic=17; Mean time post-injury=8.7 yr versus 8.0 yr.

Intervention: Sphincterotomy versus placement of a sphincteric stent (UroLume prosthesis).

Outcome Measures: Urodynamic parameters (maximum detrusor pressure, bladder capacity, post-void residual urine volume), length of hospitalization, quality of life (QoL). Collected pre-operatively and 3, 6, 12 and 24 mo post-op.

 

1.     Significant ↓ in detrusor pressure (p<0.05) relative to baseline with both treatments and no difference between sphincterotomy and stent at any time.

2.     No significant change in bladder capacity with either treatment at any time.

3.     Significant ↓ in post-void residual volume (p<0.05) at some time points but not others – no difference between treatments.

4.     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.

5.     There was little difference in subjective assessment of impact of bladder function on QoL or in the incidence of complications between the treatment groups.

6.     Those in the stent group spent less time in the hospital for the procedure (p=0.035).

El-Azab et al. 2014

Egypt

Prospective Controlled Trial

N=40

Population: Tension-free vaginal tape (TVT group): Median age: 34 yr; Gender: female; Injury etiology: spinal cord injury=16, myelomeningocele=3, spinal cord tumor=1. Pubovaginal sling (PVS group): Median age: 36 yr; Gender: female; Injury etiology: spinal cord injury=14, myelomeningocele=4, lumbar disc surgery=2.

Intervention: Individuals with neurogenic stress urinary incontinence received TVT (n=20) or PVS (n=20).

Outcome Measures: Time to failure, Urogenital Distress Inventory Short Form-6 (UDI-6), Incontinence Impact Questionnaire Short Form-7 (IIQ-7), voiding dysfunction, post-void residual urine volume (PVR), urge urinary incontinence (UUI), low compliance, unstable bladder contractions, complications.

1.     Four participants in TVT group and three participants in PVS group had objective treatment failure at their last follow-up. The time to treatment failure was not significantly different between groups.

2.     Both groups had significant decreases in UDI-6 and IIQ-7 after treatment. The UDI sub-item of frequency was significantly more reduced in the PVS group (p=0.012) and the total IIQ-7 was significantly more reduced in the IIQ-7 group.

3.     After treatment, the median PVR was significantly lower in the TVT group compared to the PVS group.

4.     All participants in PVS group had voiding dysfunction compared to only 12 participants in TVT group.

5.     The prevalence of de novo UUI was significantly higher after TVT than after PVS.

6.     At one year follow-up, two TVT participants had low compliance and four had unstable bladder contractions, compared to two PVS participants with unstable bladder contractions.

7.     Complications were infrequent for both groups, with only one TVT participant experiencing vaginal mesh erosion. The overall reoperation rate for failure was 20% in TVT and 15% in PVS.

Rivas et al. 1994

USA

Prospective Controlled Trial

N=46

Population: Mean age: 34 yr (range 18-58); Gender: males=46, females=0. All individuals had detrusor-external sphincter dyssynergia and voiding pressure >60 mm H20.

Intervention: Individuals who chose endoluminal urethral sphincter prosthesis (Urolome; n=26) were compared to those who chose conventional external sphincterotomy (n=20). Subjects were followed-up 6-20 mo.

Outcome Measures: Voiding pressure, residual urine volume, cystometric capacity, complications.

1.     After both interventions, similar results were achieved: voiding pressure dropped at 6 mo and 12 mo (p<0.001), residual urine volume dropped by 12 mo (p<0.001) and cystometric capacity remained constant (p>0.05).

2.     Prosthesis placement was associated with a significantly shorter operation, length of hospitalization, lower hospitalization cost, and less bleeding (p<0.01 for all) than sphincterotomy.

3.     The complications of stent insertion were device migration (n = 4) and secondary bladder neck obstruction (n = 2); one individual with continuing reflux required bilateral ureteral implantation.

4.     The complications of sphincterotomy were bleeding necessitating transfusion (n = 2), recurrent obstruction (n = 2), and erectile dysfunction (n = 1).

Hobson & Tooms 1992

USA

Prospective Controlled Trial

N=22

Population: SCI=12; Level of injury: paraplegia=7, tetraplegia=5, Able-bodied=10.

Intervention: Radiographic views of spinal/pelvic postural alignment at three different postures, including: neutral sitting (PIM), trunk bending right 15⁰ (PIR), and forward trunk flexion 30⁰ (P2).

Outcome Measures: Spinal and pelvic alignment.

1.     Person with SCI will sit in PIM with pelvis tilted 15⁰ more than non-injured individuals.

2.     P2 causes forward rotation of pelvis (8⁰ in able-bodied, 12⁰ in SCI).

3.     PIM posture with 100⁰ reclined backrest causes lordotic angle of 26⁰ in SCI, and 22⁰ in able-bodied (not significant).

4.     In PIM posterior pelvic tilt causes 4cm anterior displacement of ischial tuberosities compared to able-bodied.

5.     P2 causes ischial tuberosities to move posteriorly (2.7cm for SCI, 1.6cm for able-bodied). Difference is insignificant between groups.

Ke & Kuo 2010

Taiwan

Pre-Post

N=22

 

Population: Mean age at diagnosis of bladder neck dysfunction (BND)=46.7 yr; Gender: males=19, females=3; Severity of injury: ASIA scale- A=11; B=4; C=4; D=3; Level of injury- C=13; T=9

Intervention: Transurethral Incision of the Bladder Neck (TUI-BN)

Outcome Measures: Urodynamic parameters, complications

1.     9 individuals reported spontaneous voiding after catheter removal postoperatively. Urinary retention was reported in 3 individuals.

2.     19 individuals reported an open urethral sphincter during voiding after the surgery.

3.     Clinical signs of detrusor-external sphincter dyssynergia disappeared in 6 individuals and the degree of autonomic dysreflexia improved in 15 individuals.

4.     18 individuals reported satisfactory improvement in QoL index post-surgery. No complication was reported.

Bersch et al.

2009

Switzerland

Pre-Post

N=51

 

Population: Gender: males=37, females=14; SCI: 37; Level of injury: C=4, T=25, L=22; Meningomyelocele=8; Other=6; Mean follow-up time=95.9 mo

Intervention: Implantation of the modified artificial sphincter

Outcome Measures: Subjective and objective cure rates

1.     36 individuals were objectively and subjectively cured; 46 became completely continent in daily living.

2.     Median bladder capacity was 465mL; median detrusor compliance was 41.7 mL/cm H2O.

3.     16 individuals reported 18 revisions, only one implant need to be permanently removed.

Mehta & Tophill 2006

UK

Pre-Post

29

Population: SCI with detrusor-external sphincter dyssynergia; Mean age: 45 yr; Gender: males=29; Level of injury: paraplegic=12, tetraplegic=17; mean time post-injury=12.8 yr.

Intervention: Memokath stents were placed in men with suprasacral SCI.

Outcome Measures: Effectiveness, complications. Mean follow-up of 21 mo (0-47 mo).

1.     Initially all individuals found memokath to be effective in preventing incontinence.

2.     At the last follow-up, 30 of 33 stents had been removed and 23 of these were due to complications.

3.     The most common causes of stent removal included:

4.     Persistent haematuria in 3 individuals.

5.     Urinary tract infections (UTIs) in 4 (early) and 6 (later).

6.     Acute retention in 2.

7.     Migration in 7.

8.     Stent blockage by encrustation or prostatic in growth in 14.

Chancellor et al. 1995

USA

Pre-Post

N=41

Population: SCI with overactive bladder with detrusor-external sphincter dyssynergia; Mean age: 35.7 yr; Gender: males=41; Level of injury: cervical=34.

Intervention: 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 mo although other follow-up occurred up to 44 mo (mean 18 mo).

1.     All subjects achieved spontaneous reflex voiding without incontinence.

2.     Voiding pressures significantly decreased from 77cm H2O preoperatively to 35cm H2O at 12 mo and 33cm H2O at 24 mo after stent insertion (p=0.001).

3.     Post-void residual urinary volume decreased from 202mL preinsertion to 64mL at 24 mo, (p=0.001) postinsertion.

4.     No significant difference was seen in maxiumum cystometric capacity before and after insertion.

5.     No significant changes in any of the urodynamic parameters were seen after 24 mo of follow up between individuals with and those without previous external sphincterotomy.

6.     Hemorrhage requiring blood transfusion, obstructive hyperplastic epithelial overgrowth, stent encrustation or stone formation, nor soft tissue erosion occurred in any individuals.

7.     Erectile function was not affected.

8.     Complete stent epithelialization was seen in 34 individuals in just 6 mo.

9.     Stent repositioning or removal was required in 3 individuals in the first mo and 2 individuals in one yr.

Juma et al. 1995

Pre-Post

N=63

Population: SCI: Mean age: 53 yr; Level of injury: cervical=32, thoracic=25, lumbar=6; Severity of injury: complete=32, incomplete=32; Mean time post-injury=27 yr; Mean follow-up since last sphincterotomy=11 yr; Mean number of sphincterotomies=1.74.

Intervention: Follow-up evaluation of those having sphincterotomy.

Outcome Measures: Complications since sphincterotomy as determined by following: urinalysis, urine culture, urinary tract infection (UTI), urea, creatine levels, intravenous pyelogram (IVP), renal ultrasound, urodynamics, cystoscopy and voiding cystorethrogram (as indicated). Collected at follow-up at mean of 11 (2-30) yr since last sphincterotomy.

1.     No statistical comparisons reported

2.     25/63 had upper tract pathology (12 renal calculi, 11 renal scarring, 1 atrophic kidney, 1 renal cyst). 19 of these were deemed significant.

3.     Risk of significant upper tract complications in presence or absence of bacteria was 38% and 13% respectively.

4.     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).

5.     Risk for lower tract complications ↑ with ↑ in leak point pressure; 50% for those with leak point pressure of>70cm H2O; reduced to 25% when leak point pressure of<30 cm H2O.

6.     Mean post-void residual remained high (496mL).

Abdill et al. 1994

USA

Pre-Post

N=25

Population: SCI with detrusor-external sphincter dyssynergia; Mean age: 32.8 yr; Gender: males=25; Level of injury: paraplegic=2, tetraplegic=23; Mean time since injury=7.2 yr.

Intervention: 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 mo post operation.

1.     All subjects achieved spontaneous reflex voiding without incontinence and were managed with condom catheterization.

2.     Significant decrease was seen postoperatively in:

3.     Voiding pressure (p<0.001).

4.     Residual urine volume (p<0.01).

5.     No statistical difference was seen in bladder capacity after stent insertion.

6.     Complications included hydronephorsis and reflux which did not resolve in one individual and had to undergo bilateral urethral, reimplantation which resulted in a urinary tract infection, and migration of sphincter prosthesis was seen in 3 individuals.

Chancellor et al. 1993b USA

Pre-Post

N=17

Population: MS=1, SCI=16: Mean age: 34.7 yr; Gender: males=17, females=0; Level of injury: paraplegia=4, tetraplegia=13; Mean time post-injury=13 yr.

Intervention: 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 mo post procedure.

1.     Of all 17 individuals previously managed by indwelling Foley catheter, 15 now used condom catheters and 2 voided on their own.

2.     Significant ↓ in voiding pressure (p=0.008) relative to baseline at all follow-up times.

3.     No change in bladder capacity (p=0.30) at any follow-up time.

4.     Significant ↓ in post-void residual volume (p<0.05) at all follow-up times.

5.     Positive urine cultures (i.e., UTI) in 15/17 prior to surgery but only in 5, 8 and 4 of the individuals at 3, 6 and 12 mo respectively.

6.     Subjective autonomic dysreflexia improved in all 9 who had previously complained of this.

7.     Pre-existing hydronephrosis in 2 resolved.

8.     3 had subjectively improved erectile function.

9.     Post-procedural complications included bleeding (1), development of new obstructions (2), stricture (1).

Chancellor et al. 1993c

USA

Pre-Post

N=25

Population: SCI: Mean age: 32.8 yr; Gender: males=25; Level of injury: paraplegia=2, tetraplegia=23; Mean time post-injury=7.2 yr.

Intervention: 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 mo post-op.

1.     Significant ↓ in voiding pressure (p<0.001) relative to baseline at all follow-up times.

2.     No significant change in bladder capacity (p=0.57) at any follow-up time.

3.     Significant ↓ in post-void residual volume (p<0.01) at all follow-up times.

4.     Positive urine cultures (i.e., UTI) occurred in 22 of 25 individuals prior to surgery but only in 9, 11 and 4 of the individuals at 3, 6 and 12 mo respectively.

5.     Subjective autonomic dysreflexia improved in all 19 who had previously complained of this.

6.     Pre-existing hydronephrosis in 5 individuals resolved in 4.

Chartier-Kastler et al.

2011

France

Post-test

N=51

 

Population: mean age: 35 yr (18-58 yr); Gender: male=51, female=0; SCI=35; Myelomeningocele=16; Mean follow-up time: 83 mo (6-208 mo); Mean LOS=14.7 d.

Intervention: Artificial urinary sphincter insertion.

Outcome Measures: Morbidity, adverse events, removal rate of artificial urinary sphincter (AUS).

1.     The study reported 33 complications in 24 individuals which required a new procedure. The average time before refitting was 74 mo.

2.     Five infections (which led to device removal) and five erosions were observed. At the end of the study, 15 individuals had dropped out, 11 had a working AUS during study period.

3.     The average AUS lifespan was 88 mo. The most common complication was early postoperative refitting to adjust cuff size.

Losco et al. 2015

United Kingdom

Case Series

N=27

Population: Mean age: 56 yr; Gender: female; Level of injury: above T12=2, T12 and below=22, sacrectomy=3.

Intervention: Records were reviewed for those with neurogenic stress urinary incontinence who had received placement of mid-urethral synthetic transobturator tapes.

Outcome Measures: Complete correction of stress incontinence without the need to wear incontinence pads (Dry), individual satisfaction, change in bladder management, complications, occurrence of de novo overactive bladder (OAB).

1.     At mean follow-up period of 5.2 yr, 22 participants were dry and one participant was happy with the improvement.

2.     Twenty-five participants had no change in bladder management and two required clean intermittent self-catheterization.

3.     Two participants developed de novo OAB, three participants developed transient thigh pain, and no participants had bladder injuries, vaginal injuries, or tape erosions.

Vainrib et al. 2014

United States

Case Series

N=46

Population: Mean age: 21.8 yr; Level of injury: cervical=33, thoracic=13; Mean time post-injury: 355.4 mo.

Intervention: Records were reviewed for individuals receiving repeat bladder neck incision (BNI) with or without external sphincterotomy (ES).

Outcome Measures: Success rate, durability of success, complications, neurogenic detrusor overactivity (NDO), decreased bladder compliance.

1.     The 46 participants included in the analyses represent the 47.4% failure rate for initial BNI/ES.

2.     For the first revision, the success percentage was 50.0%, with the mean durability of success at 105.6 mo and the mean durability of failure at 70.4 mo.

3.     For the second revision, the success percentage was 68.2%, with the mean durability of success at 115 mo and the mean durability of failure at 65 mo.

4.     For the third revision, the success percentage was 85.7%, with the mean durability of success at 148 mo and the mean durability of failure at 24 mo.

5.     There were few complications noted perioperatively in any of the participants regardless of the number of procedures required.

6.     Preoperative percentage of participants with NDO before the first 3 redo interventions were 84.2%, 88.9%, and 75%, while there was decreased bladder compliance in 10.5%, 22.5%, and 25% of participants.

7.     The most common indications for surgery failure and need for repeat surgery were elevated residual for the first repeat BNI/ES, recurrent urinary tract infections for the second, and elevated residual for the third.

Pannek et al. 2012

Switzerland

Case Series

N=9

Population: Median age: 45.1 yr (range=27-6 yr); Gender: males=0, females=9; Level of injury: Paraplegia=4, Tetraplegia=5; Severity of injury: complete=4, incomplete=5; Mean time post-injury=11.8 yr (range=0.5-29 yr)

Bladder drainage was obtained using either intermittent catheter (IC) (n=7), spontaneous voiding (n=1) or suprapubic catheter (n=1). For all individuals, genuine stress urinary incontinence due to neurogenic bladder dysfunction was proven prior to surgery by testing for a stable detrusor in the filling phase, normal bladder compliance and bladder capacity

All individuals used incontinence devices prior to surgery (diapers (2) (each using 2/24hr), incontinence pads (7) (median=4/24hr) resp.). All individuals underwent a thorough medical history including counting the number of incontinence devices used/d, vaginal examination, renal ultrasound and video-urodynamic testing. Follow-up examination took place at 3 mo post-surgery, and once every yr after that

Median time between surgery and follow-up exam=6.8 mo.

Intervention: NA – Data analysis of stress urinary incontinence pre- and post transobturator sub-urethral tape (TOT) surgery

Outcome Measures: Use of incontinence devices, bladder capacity, detrusor compliance, maximum detrusor pressure, valsalva leak point pressure (LLP)

1.     The 2 individuals with diapers still used the same amount of diapers at follow-up, while the median number of incontinence pads was reduced from 4 to 2.6/24hr in the other 7 individuals.

2.     Of the nine individuals, only 3 showed improvement post-surgery – 2 of the 7 individuals using incontinence pads were now continent at follow-up (i.e. did not use any pads) and 1 individual reduced their pad use by 50%.

3.     Median bladder capacity pre versus post-surgery was 467 ml versus 379 ml resp. which was not statistically significant.

4.     Median detrusor compliance pre versus post-surgery was 120ml/cm H2O versus 106.7ml/cm H2O resp. which was not statistically significant.

5.     Median maximum detrusor pressure pre versus post-surgery was 11cm H2O versus 12cm H2O resp. which was not statistically significant.

6.     No new onset of detrusor overactivity was detected post-surgery.

7.     In 6 of the 9 individuals with LPP pre-surgery, the Median LPP pre versus post-surgery increased from 28cm H2O to 41.2cm H2O resp.

8.     Of the 6 individuals who did not experience treatment success, 5 underwent second-line treatment (artificial sphincter (3) or urinary diversion (2) resp.).

Abdul-Rahman et al.

2010

UK

Case Series

N=6

 

Population: Mean age: 41.8 yr (26-65 yr); Level of injury: C=11, T=1; 6 individuals followed to 20 yr.

Intervention: External urethral sphincter stents

Outcome Measures: Urodynamic variables/ video cystometrogram (VCMG), adverse events

1.     VCMG showed a significant sustained reduction of maximum detrusor pressure (p<0.01) and duration of detrusor contraction (p<0.05) at 20 yr follow-up.

2.     5 of 6 individuals developed bladder neck dyssenergia within first 9 yr of follow-up; all successfully treated with bladder neck incision (BNI)

3.     No problems with stent migration, urethral erosion, erectile dysfunction or autonomic dysreflexia noted.

4.     Two individuals lost to follow-up at 1 and 3 yr, but were complication free; two developed encrustation requiring stent removal; 1 individual died due to unrelated causes, and another developed bladder cancer and underwent cystectomy 14 yr post-insertion.

Pan et al. 2009

Australia

Case Series

N=84

Population: Mean age: 35.6 yr; Level of injury: tetraplegia=52, paraplegia=32.

Intervention: Charts of SCI individuals that underwent external sphincterotomy were reviewed.

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

5.     57 individuals had failure after initial sphincterotomy.

6.     UTI’s were the most common reason for sphincterotomy failures followed by destrusor sphincter dyssynergia and upper tract dilation.

7.     After a second sphincterotomy for 30 of the 57 individuals for whom the initial sphincterotomy failed, 13 individuals reported success.

Game et al. 2008

France

Case Series

N=147

 

Population: Mean age: 41.3 yr; Gender: males=147, females=0; Type/Level of injury: tetraplegia=85, paraplegia=24, MS=24

Intervention: Charts of individuals that underwent temporary urethral sphincter stent placement for neurogenic detrusor sphincter dysynergia.

Outcome Measures: Urinary tract infection (UTI), post voiding residual volume, autonomic hyperreflexia with individuals reviewed at 1 and 3 mo post-placement and every 3 mo thereafter.

1.     The most common early and late postoperative complication was urinary tract infection.

2.     After stent placement:

3.     Significant reduction in post-voiding residual volume was seen (p<0.0001).

4.     Number of individuals experiencing symptoms of autonomic hyperreflexia decreased significantly (p=0.0003).

5.     Significantly lower mean number of episodes of symptomatic urinrary tract infection was seen, p<0.0001).

6.     No signficant difference in outcome was noted between the Nissenkorn and Diabolo stent.

7.     Removal of stent did not result in any complications.

8.     92 of the 147 individuals had permanent urethral sphincter stent placed after removal of the temporary.

 

Seoane-Rodriguez et al. 2007

Spain

Case Series

N=47

Population: SCI with overactive bladder with detrusor-external sphincter dyssynergia: Mean age: 52.7 yr; 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%.

Intervention: Retrospective review of insertion of intraurethral stent (Memokath or UroLome).

Outcome Measures: Detrusor pressure, number of urinary tract infections (UTIs), autonomic dysreflexia, complications in the upper urinary tract, and prosthesis complications with average follow-up of 67 mo (range=14-125 mo).

1.     There was a significant decrease in detrusor pressure in most individuals, (p=0.0001).

2.     Post void residual volumes decreased 224cc (p=0.001).

3.     The presence of urinary tract infection (UTI) diminished by 25% from 67.5 to 42.5%, p=0.031.

4.     The episodes of dysreflexia also decreased significantly (p=0.039).

5.     Upper urinary tract complications decreased from 47 to 23% (p=0.013).

6.     After stent placement, 84% of people that used indwelling catheter previously were able to manage with the external drainage.

7.     The most common complication for prosthesis placement was migration, 28%.

8.     4 individuals required stent removal.

Perkash 2007

USA

Case Series

N=46

Population: Mean age: 47.7 yr; Gender: males=46; Level of injury: tetraplegia=31, paraplegia=15; Severity of injury: AIS A&B=43 ,C=3

Intervention: SCI individuals that underwent transurethral sphincterotomy were followed.

Outcome Measures: Post void residual urine, systolic blood pressure (BP), diastolic BP. Mean follow-up time 5.4±3.1 yr.

1.     Mean post void residual urine and systolic and diastolic BP decreased significantly post transurethral resection (TURS) (p<0.0001).

2.     After 1 yr, only 4 individuals still exhibited AD.

Patki et al. 2006

UK

Case Series

N=9

Population: SCI with urodynamic stress incontinence; Mean age: 38.2 yr; Gender: males=9, females=0; Level of injury: cervical=1, lumbar=3, thoracic=5; Severity of injury: complete=7, incomplete=2.

Intervention: 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 outindividual clinics at 3 mo, 6 mo, and yearly for a mean of 70.2 mo (3-133 mo).

1.     On date of activation there was a 100% continence rate and no individual reported leakage.

2.     2 individuals reported significant recurrrent incontinence at 3 mo follow up, with one implant being removed and the other being revised.

3.     At the end of 24 mo, a scrotal pump of another individual become infected and was removed.

4.     Overall 5 successful implants have had no revisions and have the original implant at a mean follow-up of 105.2 mo.

5.     No upper tract change or deterioration in renal function was noted in any individual.

6.     More than half of the individuals with working implants recorded higher maximum detrusor pressures at followup.

7.     No significant changes were seen in bladder capacity.

Note: AD=Autonomic Dysreflexia; AIS=ASIA Impairment Scale; UTI=Urinary Tract Infection; TURS=Transurethral Modified Sphincterotomy

Discussion

A common surgical method of treating bladder outlet obstruction or detrusor-sphincter dyssynergia has been transurethral sphincterotomy usually conducted in anticipation of emptying the bladder with condom drainage with reflex voiding. Autonomic dysreflexia, a common complication of high volume storage and/or high pressure voiding or leaking in those with SCI typically above T12, can be diagnosed with blood pressure monitoring during cystometrogram and urodynamic studies and subsequently better managed after successful transurethral sphincterotomy (Perkash 2007). Perkash (2007) noted a significant (p<0.0001) decrease in systolic and diastolic blood pressure after transurethral sphincterotomy as well as improved voiding and post-void residuals. However, although diminished symptoms of autonomic dysreflexia were reported, mean maximum voiding pressures changes were not significant.

Juma et al. (1995) conducted a pre post-test of 63 individuals who had received one or more sphincterotomies with a mean follow-up time of 11 years (range 2-30). This study was directed at describing the risk for long-term complications following this procedure. Although more than half of these individuals had normal upper tract imaging studies a significant proportion had complications with 25 of 63 individuals having some upper tract pathology (i.e., 12 renal calculi, 11 renal scarring, 1 atrophic kidney, 1 renal cyst), with nineteen deemed significant. Risk of significant upper tract complications in presence or absence of bacteria was 38% and 13%, respectively. Thirty out of 63 individuals had lower tract complications (i.e., 5 bladder calculi, 10 recurrent UTI, 3 urethral diverticula, 6 urethral stricture or bladder neck stenosis and 6 recurrent epididymitis). These authors noted that the most reliable urodynamic measure for predicting potential complications following sphincterotomy appeared to be an increase in leak point pressure. Complication rates of 50% were noted for those with leak point pressure of >70 cm H2O, whereas rates were reduced to 25% when leak point pressure was <30 cm H2O.

Despite possible upper renal tract protection and extended periods of satisfactory bladder function (i.e., 81 months), long-term outcome data (Pan et al. 2009) caution that high rates of recurring bladder dysfunction symptoms (68%) require approaching sphincterotomy as a staged intervention given that 36% (30/84) of patients required a second procedure to achieve the mean extended period of satisfactory bladder function. When considering these studies, it is uncertain if these high complication rates would be comparable in the event individuals had continued with their previous form of bladder management as often surgical procedures are performed only if other more conservative methods are unsuccessful. A controlled trial is required to address this issue. For cases where DESD is paired with with bladder neck dyssynergia, (which should be confirmed with videourodynamic study), Ke & Kuo (2010) have shown that transurethral incision of the bladder neck (TUI-BN) may restore contractility of the detrusor. Post-void residual volume decreased and QMax increased significantly after TUI-BN and an open urethral sphincter was noted in 19 of 22 patients studied postoperatively. In addition, autonomic dysreflexia during micturition was also reduced or eliminated in 15 of 17 patients with preoperative autonomic dysreflexia (Ke & Kuo 2010).

One alternative to sphinterotomy is placement of a stent passing through the external sphincter thereby ensuring an open passage. Several studies have been conducted examining the long-term outcomes associated with different types of stents including a wire mesh stent (UroLume) (Chancellor et al.1993b, Abdill et al. 1994, Rivas et al. 1994; Chancellor et al. 1995; Abdul-Rahman et al. 2010) and a nickel-titanium alloy tightly coiled stent (Mehta & Tophill 2006). Long-term outcomes of each of these stents were also investigated in a retrospective case series study of 47 consecutive male patients (Seoane-Rodriguez et al. 2007). All of these studies involved either retrospective case series reviews or prospective pre-post study designs and demonstrated effective treatment of incontinence initially while the stent was in place although some studies also showed the necessity for stent removal/replacement due to migration or other complications. In particular, Mehta and Tophill (2006), in a case series of 29 persons with SCI with a follow-up of up to 47 months, suggested that the “working life” of the Memokath stent was 21 months. They noted that complications most commonly leading to removal included stent blockage by encrustation, migration (especially in single-ended models), UTIs and persistent haematuria. Others have noted similar issues but typically have reported lower rates of complications leading to stent removal (Abdill et al. 1994, Chancellor et al. 1995, Seoane-Rodriguez et al. 2007; Abdul-Rahman et al. 2010). Despite these issues, when the stents are in place they appear to be effective, resulting in significant reductions in voiding pressure and post-void residual urine volumes although no significant changes have been noted in bladder capacity (Chancellor et al.1993b; Abdill et al. 1994; Chancellor et al. 1995; Seoane-Rodriguez et al. 2007; Abdul-Rahman et al. 2010). In addition, reduced incidence of UTIs and autonomic dysreflexia has typically been reported (Chancellor et al.1993c; Seoane-Rodriguez et al. 2007). Game et al. (2008) advocate for a trial period with a temporary stent early post-injury based on the percentage of patients (~30%) not choosing placement of a permanent stent or in whom the stent did not provide the expected results. This reversible management option is however, limited by the available materials for temporary stenting. Rivas et al. (1994) reported a clear patient bias in favour of the stent because of its short- and long-term reversibility. The authors also concluded that the stent was equivacol to external sphincterotomy in terms of urodynamic values and superior for reasons of reduced surgery, hospitalization, costs and hemorrhage as an adverse event.

Chancellor and colleagues (1999) also conducted a RCT (n=57) comparing the outcomes associated with sphincterotomy as compared to placement of the stent (UroLome) prosthesis. This study was deemed a low quality RCT, largely because blinding and concealed allocation was not possible given the nature of the intervention. Similar measurement procedures and overall findings were noted as reported for the studies above (i.e., Chancellor et al. 1993c) with significant decreases in voiding detrusor pressure and post-void residual urine volumes and no significant changes reported for bladder capacity and no differences noted between sphincterotomy and stent for any measure at any time point (i.e., 3, 6, 12 and 24 months). The need for catheterization, initially required in 50% of the sphincterotomy group (n=26) and 71% of the stent group (n=31), was reduced to no more than four individuals at all follow-up timepoints for both groups. There was little difference in subjective assessment of impact of bladder function on QoL or in the incidence of complications between the treatment groups although those in the stent group spent less time in the hospital for the procedure.

Chancellor et al. (1993b) also have examined another procedure with similar rationale as that associated with sphincterotomy. This investigation involved a pre-post trial design (n=17) of transurethral balloon dilation of the external urinary sphincter. Again, similar methods were employed as the studies noted above and findings were also similar. Of all 17 patients previously managed by indwelling Foley catheter, 15 used condom catheters post-procedure and two voided on their own. Significant decreases were noted in voiding pressure (p=0.008) at all follow-up times (i.e., 3, 6 and 12 months). No changes were observed in bladder capacity (p=0.30); significant reductions in post-void residual urine volumes (p<0.05) were observed at all follow-up times. Positive urine cultures (i.e., UTI) were noted in 15 of 17 subjects prior to surgery but only in 5, 8 and 4 patients at 3, 6 and 12 months, respectively. Subjective autonomic dysreflexia improved in all nine individuals who had previously experienced AD.

More recently, Patki et al. (2006) reported a small retrospective case series investigation (n=9) of an implantation of an artificial urinary sphincter (AUS; American Medical System 800). This device has evolved over the years to where it is now easier to implant surgically, has a longer life and a higher success rate in achieving incontinence (~80% with more recent models). In this trial, all patients achieved successful incontinence with no self-reported leakage upon activation of the system. However, by 3-month follow-up, two patients reported significant recurrrent incontinence, with one implant being removed and the other being revised; by a mean follow-up of 105.2 months, 5 of 9 implants had been successful with no revisions. Overall, more than half of the patients with working implants recorded higher maximum detrusor pressures although no upper tract change or deterioration in renal function was noted in any patient. A retrospective analysis in 2009 by Bersch et al. of individuals (n=51) who underwent implantation of an artificial sphincter at the bladder neck using a port instead of a pump suggested this approach to be highly successful, reliable, safe and a cost-effective treatment option (even with implant revisions). Additionally, a retrospective review by Chartier-Kastler et al. (2011) determined an artificial urinary sphincter device was effective in restoring urinary continence in males, in the majority of cases reviewed, with a decrease in urethral erosion by placement of the device around the bladder neck, providing more credence to consideration for SCI patients.

Based on the success of safety and efficacy of tension-free vaginal tape for stress incontinence in feamles with neuropathic bladders (N=12; NSCI=3), Hamid et al. 2003 concluded that tension-free vaginal tape was safe for the treatment of women with neuropathic intrinsic sphincter deficiency. Pannek et al. (2012), with the promise of the work of Hamid et al. (2003) and a long history of success in improving continence for women with non-neurogenic stress incontinence, sought to evaluate the use of transobturator tape for women suffering from stress incontinence of neurogenic origin secondary to SCI. Even by eliminating sources of variability for success such as material type and surgical competence, the results of this case series (n=9) yielded unfavourable results. Low cough or valsalva induced leak point pressure incontinence and high complication rates of the procedure led the authors to conclude that the transobturator tape was not a viable option for the treatment of SCI related neurogenic stress incontinence. Other attributions to the interventional failure in this patient population were thought to be related to the specific type and grade of detrusor deficiency and the prevalence of pelvic deformity development (Hobson & Tooms 1992) such as a posteriorly tilted pelvis that would interfere with the position of the obturator foramen.

Conclusion

There is level 4 evidence (from one case series study; Perkash 2007) that sphincterotomy is effective in reducing episodes of autonomic dysreflexia associated with inadequate voiding.

There is level 4 evidence (from one case series study; Pan et al. 2009) that sphincterotomy, as a staged intervention, can provide long-term satisfactory bladder function.

There is level 2 evidence (from a one RCT and several level 4 studies; Chancellor et al. 1999) that both sphincterotomy and implantation of a sphincteric stent are effective in reducing incontinence, with little need for subsequent catheterization, and both treatments are associated with reduced detrusor pressure and reduced post-void residual volume but not with changes in bladder capacity. The only significant difference in these two treatments was the reduced initial hospitalization associated with the stent, given the lesser degree of invasiveness.

There is level 4 evidence (from one pre-post study and one case series study; Chancellor et al. 1993c; Seoane-Rodriguez et al. 2007) that implantation of a sphincteric stent may result in reduced incidence of UTIs and bladder-related autonomic dysreflexia over the short-term although several studies have demonstrated the potential for various complications and subsequent need for re-insertion or another approach over the long-term.

There is level 4 evidence (from one pre-post studroy; Juma et al. 1995) that over the long-term, previous sphincterotomy may contribute to a high incidence of various upper and lower tract urological complications.

There is level 4 evidence (from one case series study; Game et a. 2008) that advocates for placement of a temporary stent early after injury as a reversible option that allows patients to choose from the range of permanent stent placement to less invasive bladder management methods such as intermittent catheterization.

There is level 4 evidence (from one pre-post study; Chancellor et al. 1993b) that transurethral balloon dilation of the external sphincter may permit removal of indwelling catheters in place of condom drainage, and also may result in reduced detrusor pressure and post-void residual volume but not with changes in bladder capacity.

There is level 4 evidence (from one case series study and one pre-post study; Patki et al. 2006 Bersch et al. 2009) that implantation of an artificial urinary sphincter may be useful in the treatment of incontinence in SCI but further study is required.

There is level 4 evidence (from one pre-post study; Ke & Kuo 2010) that transurethral incision of the bladder neck may be useful in bladder neck and voiding dysfunction.

There is level 4 evidence (from one case series study; Pannek et al. 2012) that transobturator tape implantation is not effective in managing neurogenic stress incontinence in females living with SCI.

Surgical and prosthetic approaches (with a sphincterotomy and stent respectively) to allow bladder emptying through a previously dysfunctional external sphincter both seem equally effective resulting in enhanced drainage although both may result in long-term upper and lower urinary tract complications.

Artificial urinary sphincter implantation and transurethral balloon dilation of the external sphincter may be associated with improved bladder outcomes but require further study.

Transobturator tape implantation is not effective for SCI-related neurogenic stress incontinence and results in high complication rates.