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. |