- Email: [email protected]
External Sphincter in Patients With Spinal Cord Injury
Reconstructive Urology Long-term Efficacy of Repeat Incisions of Bladder Neck/External Sphincter in Patients With Spinal Cord Injury Michael Vainrib, Polina Reyblat, and David A. Ginsberg OBJECTIVE
METHODS RESULTS
CONCLUSION
To evaluate the efficacy of repeat bladder neck incision (BNI), with or without external sphincterotomy (ES). BNI/ES has been commonly used for management of neurogenic bladder in spinal cord injury (SCI) patients. This was a retrospective review of institutional review boardeapproved SCI database. A total of 97 patients underwent BNI/ES over a period of 40 years. During the period reviewed, a solitary redo BNI/ES was done in 46 patients, a second redo BNI/ES was done in 23 patients, and a third redo BNI/ES was done in 7 patients with success rates of 50%, 68.2%, and 85.7%, respectively. 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 repeat BNI/ES. All patients had a normal serum creatinine level at the end of the follow-up. Mean elapsed follow-up after the last redo BNI/ES was 119 months (range, 6-408 months) for all patients evaluated. Mean durability of successful redo BNI/ES was 109.1 months, which was significantly longer than mean durability of failed redo BNI/ES at 69.4 months (P <.05). SCI patients undergoing BNI/ES may require repeat BNI/ES to optimize lower urinary tract management. The success rate ranges from 50% to 85.7% after 3 repeat BNI/ES procedures with acceptable long-term durability and low perioperative complication rates. UROLOGY 84: 940e945, 2014. 2014 Elsevier Inc.
T
he two primary goals in the urologic management of neurogenic bladder (NGB) dysfunction include protecting the patient’s upper urinary tract and allowing the patient to maintain optimal urinary control. When deciding how to treat a patient with NGB, issues that should be addressed include the type and level of injury, type of bladder dysfunction, the patient’s ability or desire to perform clean intermittent catheterization (CIC), and the cause of NGB. Treatment options include pharmacologic treatment, indwelling catheters, reflex voiding to a condom catheter, use of diapers or pads, CIC, and lower urinary tract reconstruction. NGB patients with suprasacral spinal cord injury (SCI) may suffer from storage, emptying, or combined dysfunction. Their emptying ability is usually impaired by detrusor external sphincter dyssynergia (DESD) and incomplete The project was performed at Rancho Los Amigos National Rehabilitation Center, Downey, CA. Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, University of Southern California, Los Angeles, CA; the Department of Urology, Meir Medical Center, Kfar Saba, Israel; the Urology Service, Rancho Los Amigos National Rehabilitation Center, Downey, CA; and the Department of Urology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA Reprint requests: Michael Vainrib, M.D., Department of Urology, Meir Medical Center, 59 Tschernichovsky Street, Kfar Saba 44410, Israel. E-mail: mvainrib@gmail. com Submitted: March 19, 2014, accepted (with revisions): June 3, 2014
940
ª 2014 Elsevier Inc. All Rights Reserved
bladder contractions (ie, a bladder contraction that is not sustained until the bladder is adequately emptied). In addition, patients with cervical SCI may have increased outlet resistance secondary to combined DESD and detrusor internal sphincter dyssynergia (DISD). CIC remains the gold standard treatment in SCI patients with impaired emptying. The primary treatment options for SCI patients who are unable or unwilling to perform CIC include the use of an indwelling catheter or reflex voiding to a condom catheter (often in association with a blockers),1 bladder neck/external sphincter incision (BNI/ES),2-6 urethral stent (permanent/reversible),7-9 or intrasphincteric injection of botulinum toxin.10-13 In rare cases, lower urinary tract reconstruction may be required with options including ileovesicostomy14 or ileal conduit, with or without concomitant cystectomy.15 BNI/ES is a commonly used minimally invasive option for DESD/DISD. The limited success rates of this procedure may lead to repeat BNI/ES. Our goal was to review the outcomes of patients who had repeat BNI/ES and evaluate for possible causes of failure of the procedure.
METHODS A retrospective review of adult patients followed in the urology clinic at Rancho Los Amigos National Rehabilitation Center http://dx.doi.org/10.1016/j.urology.2014.06.009 0090-4295/14
was performed. For this review, we used an institutional review boardeapproved database of SCI patients between 1971 and 2011. We were able to identify 97 patients who had undergone BNI/ES. Forty-six of 97 (47.4%) of patients underwent at least 1 redo BNI/ES and were included in the analyses. Common indications for redo BNI/ES included autonomic dysreflexia (AD), elevated detrusor pressures, recurrent urinary tract infection (UTI), elevated post-void residual (PVR), hydronephrosis, or new-onset renal insufficiency/failure. During follow-up, all SCI patients in our institution undergo a similar yearly evaluation: serum creatinine, renal ultrasonography (U/S), and kidney-ureter-bladder. Further evaluation is undertaken based on abnormal signs or symptoms (history of recurrent UTI, AD, history of impaired emptying, and newonset incontinence) or abnormal radiographic or laboratory findings such as new-onset hydronephrosis or renal insufficiency. Indications for ES alone vs BNI alone vs combined BNI/ES are presently based on urodynamic and radiographic findings that allow for identification of the likely site of obstruction. However, for many patients who underwent intervention earlier in the study period, the default procedure was BNI/ES no matter what was identified radiographically or urodynamically. The level of obstruction was not necessarily identified, and both the external and internal sphincters were incised. ES was performed using a cold knife or electrocautery with an incision at the 12-o’clock position. The incision was made from the midprostatic urethra through the bulbomembranous junction to achieve adequate division of striated muscles of external sphincter. Bladder neck incision was performed with 2 incisions extending from just distal to the ureteral orifices, through the bladder neck, and into the prostatic urethra. If the indication for BNI/ES resolved, then the procedure was defined as a success. Failure of BNI/ES was defined as lack of improvement in regards to the primary indication for intervention or subsequent recurrence during the follow-up period (for a similar or different indication) requiring redo BNI/ES. We also documented all alternative treatments that SCI patients had chosen for impaired bladder emptying.
RESULTS Initial BNI/ES procedures were performed in 97 SCI patients. The success rate of the initial procedure was 52.6%, with a mean durability of 106.6 months (range, 6-372 months). Indications for the initial BNI/ES in the general cohort were elevated bladder pressures: 67 (69.1%), recurrent UTI: 13 (13.4%), AD: 2 (2.1%), elevated PVR: 2 (2.1%), and hydronephrosis: 1 (1%). The reason for BNI/ES could not be identified for the remaining 12 patients (12.4%). Forty-six (47.4%) of those patients had eventual failure of the initial procedure and required redo BNI/ES. Our retrospective data analysis will be focused on these 46 patients who were included in the study cohort. The mean follow-up of these 46 patients was 355.4 months (range, 120-816 months) after injury, with a mean age at injury of 21.8 7.5 years (range, 7-45). Thirty-three patients (71.7%) had cervical and 13 (28.3%) had thoracic-level SCI. The etiology of SCI was gunshot wound: 19 (41.3%), motor vehicle accident: 15 (32.6%), UROLOGY 84 (4), 2014
diving: 8 (17.4%), fall: 2 (4.3%), sport injury: 1 (2.2%), and transverse myelitis: 1 (2.2%). The mean age of our study cohort at the initial BNI/ES was 30.7 10.3 years (range, 16-62 years). The mean elapsed time from injury to the first BNI/ES was 109.5 116.0 months (1-660 months), and the mean follow-up after the last BNI/ES was 119 months (6-408 months). Bladder management of patients before the initial procedure was external condom catheter in 29 (63.0%), CIC with external condom catheter in 8 (17.4%), indwelling catheter (urethral or suprapubic) in 4 patients (8.7%), and unknown bladder management in 5 of 46 patients. Indications, success rates, and durability of initial BNI/ ES and the following redo procedures are noted in Figure 1. The success rates of the initial BNI/ES and the following 3 redo procedures ranged between 50.0% and 85.7%. The mean durability of success after BNI/ES ranged between 105.6 and 148.0 months and was significantly longer (P <.05, t test: 2-tailed, unpaired) than the mean time to failure at each level of redo procedure (range, 24-72.8 months; Fig. 1). The most common indications to perform a redo BNI/ES were elevated PVR (first and third redo procedures) and recurrent UTI (second redo procedure; Fig. 1). The various interventions performed at each redo procedure are shown in Figure 2. The most common procedure at the time of the first and second procedures was BNI/ES followed by ES. The most common procedure at the time of the third redo procedure was ES followed by BNI/ES. There were few complications noted perioperatively in any of these patients no matter how many procedures were required. The most commonly noted event was postoperative bleeding; yet, none of the patients studied required a blood transfusion. Urosepsis was noted in 1 patient after the first redo procedure; this occurred despite appropriate antibiotic therapy for a positive urine culture that was obtained and treated preoperatively. Most patients had normal renal and bladder U/S results throughout their follow-up period. A total of 3 patients had hydronephrosis at some point during follow-up, which improved in 2 of these patients after the first redo intervention. One patient with hydronephrosis before his second repeat procedure showed improvement after BNI/ES. Bladder stones were noted in 3 patients preoperatively at some point during the follow-up; those patients underwent cystolitholapaxy at the time of BNI/ES without evidence for recurrent stones with further follow-up. Preoperative urodynamic findings included DESD/ DISD with neurogenic detrusor overactivity (NDO) before the first 3 redo interventions in 84.2%, 88.9%, and 75% and decreased bladder compliance bladder in 10.5%, 22.5%, and 25% of patients, respectively. The mean serum creatinine level of the study cohort at the end of the follow-up was 0.51 0.18 (0.3-1.1). In our study cohort, 1 patient who had failed redo BNI/ ES and was not interested in an indwelling catheter chose 941
Initial BNI/ES = 97 (100%) patients Elevated bladder pressures = 67(69.1%) History of Recurrent UTIs=13(13.4%) History of Elevated PVR=2(2.1%) AD=2(2.1%) Hydronephrosis=1(1.0%) Unknown=12(14.2%) FAILURE
SUCCESS Mean Durability= 106.6 (6-372) months
Mean Durability= 72.8 (6-300) months
Revision #1 BNI/ES = 46 (47.4%) patients Elevated bladder pressures =11(23.9%) History of Recurrent UTIs= 11(23.9%) History of Elevated PVR=15(32.6%) AD=0 (0%) Hydronephrosis=3(6.5%) Unknown=6(13.1%)
SUCCESS 51 (52.6%) patients
SUCCESS
FAILURE
Mean Durability= 105.6 (12-408) months
Mean Durability= 70.4 (2-216) months
Revision #2 BNI/ES = 23 (50.0%) patients Elevated bladder pressures =4(17.4%) History of Recurrent UTIs=8(34.8%) History of Elevated PVR=2(8.7%) AD=5(21.8%) Hydronephrosis=1(4.3%) Unknown=3(13.0%)
SUCCESS 23 (50.0%) patients
FAILURE
SUCCESS Mean Durability= 115 (6-336) months
Mean Durability= 65 (12-192)
Revision #3 BNI/ES = 7 (31.8%) patients Elevated bladder pressures =0(0%) History of Recurrent UTIs=2(28.6%) History of Elevated PVR=4(57.2%) AD=1(14.2%) Hydronephrosis=0(0%) Unknown=0(0%)
SUCCESS 15 (68.2%) patients
SUCCESS
FAILURE
Mean Durability=148 (12-288) months
Mean Durability=24 months
Revision #4 BNI/ES = 1 (14.3%) patients Elevated bladder pressures = 1 (100%)
SUCCESS 6 (85.7%) patients
Figure 1. Indications for BNI/ES and the durability of each procedure. AD, autonomic dysreflexia; BNI/ES, bladder neck incision with or without external sphincterotomy; UTI, urinary tract infection.
to proceed with ileovesicostomy and bladder neck closure. In addition, 7 patients had an intervention before their initial BNI/ES: 5 UroLume (American Medical Systems, Minnetonka, MN) stent placements and 2 internal urethrotomies.
COMMENT A total of 46 patients underwent at least 1 redo BNI/ ES, with a success rate ranging between 50.0% and 85.7% at the first 3 redo procedures. Mean durability of BNI/ES was significantly longer after a successful 942
intervention compared with a failed procedure. The primary indications for BNI/ES were elevated bladder pressures, history of elevated PVR, and history of recurrent UTI. The most common urodynamic findings before BNI/ES included normal compliance, NDO, and DESD/DIESD. Most patients maintained normal upper tracts during the follow-up period, as evaluated by yearly renal U/S. The main goal in the treatment of SCI patients with DESD is the maintenance of low detrusor storage pressures, adequate emptying of the bladder, and prevention of problems such as recurrent UTI, AD, and UROLOGY 84 (4), 2014
35 BNI/ES
ES
BNI
UNKNOWN
30 25 20 15 10 5 0
REVISION REVISION REVISION REVISION REVISION PROCEDURE PROCEDURE PROCEDURE PROCEDURE PROCEDURE #1 #2 #3 #4 #5
Figure 2. Types of interventions at revision bladder neck incision with or without external sphincterotomy.
renal insufficiency. The gold standard treatment is CIC. Bladder management options for patients who are not able or willing to perform CIC include use of an indwelling catheter, reflex voiding to a condom catheter, often in association with a blockers,1 BNI/ES,2-6 urethral stent (permanent/reversible),7-9 or intrasphincteric injection of botulinum toxin10-13 and in rare cases lower urinary tract reconstruction. Surgical sphincterotomy can be performed with knife electrode, resection with a loop, or via laser ablation. Potential indications for sphincterotomy include elevated detrusor pressures, recurrent UTI and urosepsis, AD, elevated PVR, and upper tract deterioration; thus, the definition of success is not the same for all patients evaluated. This can be a challenge when evaluating the outcome of this procedure as the definition of success may not be the same from patient to patient as the indication for the surgery may vary from patient to patient. In previous reports, long-term success with a single sphincterotomy has not been maintained in 40%60% of patients. Pan et al16 cites an initial BNI/ES success rate of 32%. Failure of the initial BNI/ES was managed by redo BNI/ES in 53% of patients with the remaining 47% of patients managed by an alternative treatment. In this series, the authors noted a 43% success rate after the first redo BNI/ES. Only 1 patient subsequently underwent a second redo BNI/ES with the remainder of failures undergoing alternative treatments. The mixture of different procedures during the follow-up after initial BNI/ES, as well as single redo BNI/ES, makes it hard to conclude the outcome of multiple redo surgeries.2,16 Santiago3 reported his initial BNI/ES success rates to be 64% during 10 years of retrospective follow-up. Yang
UROLOGY 84 (4), 2014
and Mayo5 reported a 51% success rate of initial BNI/ ES, but no redo surgeries were reported in this cohort. In the last report, the follow-up period after the surgery was relatively short, and small study cohort could possibly cause bias for initial success rates. Noll et al6 reported the need for redo BNI/ES surgery in 57% of patients. The initial BNI/ES success rate in our series (52.6%) is comparable with previous reports in literature.2-6,16 The mean durability of the initial and redo procedures in our study appears to be longer than what has been previously reported in literature.2-6,16 Pan et al16 reported the mean durability of success after BNI/ES ranging between 68.5 and 71.0 months, which is significantly shorter than that in our study cohort (give our numbers). In addition, their reported median durability from prior BNI/ES to redo procedure was also significantly shorter (36-50 months) than that in our similar cohort (mean, 72.8 months; range, 6-300 months). However, this may be a reflection of our study cohort, which is larger than other reports in literature and from a dedicated neurorehabilitation facility. This may lend itself to easier long-term follow-up as patients tend to continue with their care at our institution after their initial postinjury rehabilitation. Mean time to failure after the initial and subsequent redo interventions at our study cohort was longer than that reported in literature before.2-6,16 It is not clear if this is a reflection of different study populations or different thresholds and indications for reintervention at each institution, impacting the time to failure. Not surprisingly, at each stage, the durability of the procedure was longer in the “success” group compared with the failure group requiring further intervention.
943
Success rates of the first 3 redo procedures ranged between 50.0% and 86.7%. In our study, we looked at success based on indication (elevated bladder pressures, elevated PVR, recurrent UTIs, AD, or hydronephrosis) for BNI/ES as did other reports in literature.2,4-6 Like other reports in literature, we could not find an association between indication and likelihood of success or failure. Unfortunately, there was no cutoff time to predict multiple failures and a need to perform redo surgeries. Proposed potential causes for failure include recurrent DESD due to an incomplete resection or fibrotic changes in the area of resection, bladder neck contracture, change in detrusor function (such as NDO, poor contractility, poorly sustained bladder contraction, or poor bladder compliance), change in neurologic function, urethral stricture, and the development of prostatic obstruction.2-6 It is interesting to note that urethral stricture or bladder neck contracture was not found in any of these patients requiring redo BNI/ES. This reflects some of the challenges in treating these patients. Although we do not know what the endoscopic findings would be for the patients who were a success and did not require reintervention, we did not appreciate indicators of anatomic obstruction such as contracture or stricture in this cohort of patients requiring redo BNI/ES. This reflects the likely multifactorial nature of their lower urinary tract dysfunction (both bladder and outlet) and the importance of urodynamics to help with decision making. One of our patients underwent an alternative procedure to BNI/ES during the follow-up. Urethral stent (permanent or temporary) could be an alternative treatment in the failed patients. One of these alternatives is the UroLume, which can be placed at the level of the external sphincter. It has been proven to be an efficient treatment with long-term follow-up.7 Chancellor et al,8 with follow-up >5 years, cited a statistically significant decrease in mean voiding pressure and mean postvoiding residual. AD was found at baseline in 115 of the patients in the study and was resolved in 70% of these at 1 year after stent placement. An additional study prospectively evaluated 40 patients who underwent ES or UroLume placement.9 Urodynamic outcomes were equivalent between the 2 groups; however, the patients who had an UroLume placed had significantly shorter operative time and hospital stays, lower hospitalization costs, and less bleeding than did patients who had had ES. However, there are potential long-term issues with UroLume placement including encrustation, recurrent UTI, overgrowth of granulation tissue, and possible obstruction. Removal of a previously placed UroLume can be very challenging and may lead to complications such as retained wires, urethral injury, and urethrocutaneous fistula.17 The UroLume is presently no longer being produced and is not available commercially for use.
944
An indwelling catheter could be an alternative treatment in this subset of patients. However, an indwelling catheter is associated with significant potential morbidity and includes risks of recurrent UTI, hematuria, bladder stones, vesicoureteral reflux, traumatic erosion of the urethra, and bladder cancer.18,19 One option that allows the use of an indwelling catheter but eliminates the potential risk of urethral erosion is use of a suprapubic tube. Indwelling catheters should be changed monthly to reduce risk of recurrent infections. By the study end, 4 of our study cohort patients ended up managing their lower urinary tract with an indwelling catheter (3 suprapubic tubes and 1 urethral catheter). Ileovesicostomy and simple cystectomy with ileal conduit formation are much more involved surgical procedures that are usually reserved for patients who have failed more conservative, less morbid options. Because SCI patients tend to be younger, lower urinary reconstruction may be a reasonable option for patients who wish to avoid the potential consequences of longterm use of an indwelling catheter. 18,19 One patient in our study cohort ultimately underwent ileovesicostomy and bladder neck closure after a failed BNI/ES revision. Although we report the largest series of BNI/ES and redo interventions in literature, our study poses several weaknesses, including retrospective design, missing data, and lack of quality-of-life data. The length of study period is both a positive and a negative. Certainly, the longer study period allows for a greater period of follow-up of these procedures. However, with this longer study period, we have had several urologists practicing with possibly different indications for intervention and possibly different surgical techniques. The change in treatment strategies is reflected in the fact that patients early in the period studied routinely would get a BNI/ES if an intervention was required; presently, we use a combination of clinical history and videourodynamic findings to guide our decision making as to whether the patient would benefit from BNI/ES, ES, BNI, or an alternative procedure. Prospective studies are needed to better understand the outcomes of repeated interventions in the lower urinary tract and their impact on quality of life of SCI patients who are mostly young at their injury and will require long follow-up and multiple procedures.
CONCLUSION Repeat surgery may be necessary for NGB patients managing their lower urinary tract with a combination of reflex voiding to condom catheter drainage after BNI/ES. Success rates ranges from 49% to 86% after 3 repeat BNI/ ES procedures with acceptable long-term durability and low perioperative complication rates. It is important to communicate with patients that repeat surgery or alternative bladder management might have to be explored in case of BNI/ES failure.
UROLOGY 84 (4), 2014
References 1. Consortium for Spinal Cord Medicine. Bladder management for adults with spinal cord injury: a clinical practice guideline for health-care providers. J Spinal Cord Med. 2006;29: 527-573. 2. Juma S, Mostafavi M, Joseph A. Sphincterotomy: long-term complications and warning signs. Neurourol Urodyn. 1995;14:33-41. 3. Santiago JA. Sphincterotomy failure. J Am Paraplegia Soc. 1993;16: 164-168. 4. Vapnek JM, Couillard DR, Stone AR. Is sphincterotomy the best management of the spinal cord injured bladder? J Urol. 1994;151: 961-964. 5. Yang CC, Mayo ME. External urethral sphincterotomy: long term follow-up. Neurourol Urodyn. 1995;14:25-31. 6. Noll F, Sauerwein D, Stohrer M. Transurethral sphincterotomy in quadriplegic patients: long-term-follow-up. Neurourol Urodyn. 1995; 14:351-358. 7. Abdul-Rahman A, Ismail S, Hamid R, et al. A 20-year follow-up of the mesh wallstent in the treatment of detrusor external sphincter dyssynergia in patients with spinal cord injury. BJU Int. 2010;106: 1510-1513. 8. Chancellor MB, Gajewski J, Ackman CF, et al. Long-term follow up of the North American multicenter UroLume trial for the treatment of external detrusor-sphincter dyssynergia. J Urol. 1999;161:1545-1550. 9. Rivas DA, Chancellor MB, Bagley D. Prospective comparison of external sphincter prosthesis placement and external sphincterotomy in men with spinal cord injury. J Endourol. 1994;8: 89-93.
UROLOGY 84 (4), 2014
10. Dykstra DD, Sidi AA, Scott AB, et al. Effects of botulinum A toxin on detrusor-sphincter dyssynergia in spinal cord injury patients. J Urol. 1988;139:919-922. 11. Schurch B, Hauri D, Rodic B, et al. Botulinum-A toxin as a treatment of detrusor-sphincter dyssynergia: a prospective study in 24 spinal cord injury patients. J Urol. 1996;155:1023-1029. 12. Smith CP, Nishiguchi J, O’Leary M, et al. Single-institution experience in 110 patients with botulinum toxin A injection into bladder or urethra. Urology. 2005;65:37-41. 13. Appell RA. Urethral and bladder injections for incontinence including botox. Urol Clin North Am. 2011;38:1-6. 14. Leng WW, Faerber G, Del Terzo M, et al. Long-term outcome of incontinent ileovesicostomy management of severe lower urinary tract dysfunction. J Urol. 1999;6:1803-1806. 15. Ginsberg DA, Rovner ES, Raz S. Complications of urinary diversion. In: Taneja S, Smith RB, Ehrlich R, eds. Complications in Urologic Surgery. Philadelphia: WB Saunders; 2001: 454-467. 16. Pan D, Troy A, Rogerson J, et al. Long-term outcomes of external sphincterotomy in a spinal injured population. J Urol. 2009;181: 705-709. 17. McFarlane IP, Foley SJ, Shah PJ. Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia. Br J Urol. 1996;78:729-732. 18. Hackler RH. Long-term suprapubic cystostomy drainage in spinal cord injury patients. Br J Urol. 1982;54:120-121. 19. Broecker BH, Klein FA, Hackler RH. Cancer of the bladder in spinal cord injury patients. J Urol. 1981;125:196-197.
945
METHODS RESULTS
CONCLUSION
To evaluate the efficacy of repeat bladder neck incision (BNI), with or without external sphincterotomy (ES). BNI/ES has been commonly used for management of neurogenic bladder in spinal cord injury (SCI) patients. This was a retrospective review of institutional review boardeapproved SCI database. A total of 97 patients underwent BNI/ES over a period of 40 years. During the period reviewed, a solitary redo BNI/ES was done in 46 patients, a second redo BNI/ES was done in 23 patients, and a third redo BNI/ES was done in 7 patients with success rates of 50%, 68.2%, and 85.7%, respectively. 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 repeat BNI/ES. All patients had a normal serum creatinine level at the end of the follow-up. Mean elapsed follow-up after the last redo BNI/ES was 119 months (range, 6-408 months) for all patients evaluated. Mean durability of successful redo BNI/ES was 109.1 months, which was significantly longer than mean durability of failed redo BNI/ES at 69.4 months (P <.05). SCI patients undergoing BNI/ES may require repeat BNI/ES to optimize lower urinary tract management. The success rate ranges from 50% to 85.7% after 3 repeat BNI/ES procedures with acceptable long-term durability and low perioperative complication rates. UROLOGY 84: 940e945, 2014. 2014 Elsevier Inc.
T
he two primary goals in the urologic management of neurogenic bladder (NGB) dysfunction include protecting the patient’s upper urinary tract and allowing the patient to maintain optimal urinary control. When deciding how to treat a patient with NGB, issues that should be addressed include the type and level of injury, type of bladder dysfunction, the patient’s ability or desire to perform clean intermittent catheterization (CIC), and the cause of NGB. Treatment options include pharmacologic treatment, indwelling catheters, reflex voiding to a condom catheter, use of diapers or pads, CIC, and lower urinary tract reconstruction. NGB patients with suprasacral spinal cord injury (SCI) may suffer from storage, emptying, or combined dysfunction. Their emptying ability is usually impaired by detrusor external sphincter dyssynergia (DESD) and incomplete The project was performed at Rancho Los Amigos National Rehabilitation Center, Downey, CA. Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, University of Southern California, Los Angeles, CA; the Department of Urology, Meir Medical Center, Kfar Saba, Israel; the Urology Service, Rancho Los Amigos National Rehabilitation Center, Downey, CA; and the Department of Urology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA Reprint requests: Michael Vainrib, M.D., Department of Urology, Meir Medical Center, 59 Tschernichovsky Street, Kfar Saba 44410, Israel. E-mail: mvainrib@gmail. com Submitted: March 19, 2014, accepted (with revisions): June 3, 2014
940
ª 2014 Elsevier Inc. All Rights Reserved
bladder contractions (ie, a bladder contraction that is not sustained until the bladder is adequately emptied). In addition, patients with cervical SCI may have increased outlet resistance secondary to combined DESD and detrusor internal sphincter dyssynergia (DISD). CIC remains the gold standard treatment in SCI patients with impaired emptying. The primary treatment options for SCI patients who are unable or unwilling to perform CIC include the use of an indwelling catheter or reflex voiding to a condom catheter (often in association with a blockers),1 bladder neck/external sphincter incision (BNI/ES),2-6 urethral stent (permanent/reversible),7-9 or intrasphincteric injection of botulinum toxin.10-13 In rare cases, lower urinary tract reconstruction may be required with options including ileovesicostomy14 or ileal conduit, with or without concomitant cystectomy.15 BNI/ES is a commonly used minimally invasive option for DESD/DISD. The limited success rates of this procedure may lead to repeat BNI/ES. Our goal was to review the outcomes of patients who had repeat BNI/ES and evaluate for possible causes of failure of the procedure.
METHODS A retrospective review of adult patients followed in the urology clinic at Rancho Los Amigos National Rehabilitation Center http://dx.doi.org/10.1016/j.urology.2014.06.009 0090-4295/14
was performed. For this review, we used an institutional review boardeapproved database of SCI patients between 1971 and 2011. We were able to identify 97 patients who had undergone BNI/ES. Forty-six of 97 (47.4%) of patients underwent at least 1 redo BNI/ES and were included in the analyses. Common indications for redo BNI/ES included autonomic dysreflexia (AD), elevated detrusor pressures, recurrent urinary tract infection (UTI), elevated post-void residual (PVR), hydronephrosis, or new-onset renal insufficiency/failure. During follow-up, all SCI patients in our institution undergo a similar yearly evaluation: serum creatinine, renal ultrasonography (U/S), and kidney-ureter-bladder. Further evaluation is undertaken based on abnormal signs or symptoms (history of recurrent UTI, AD, history of impaired emptying, and newonset incontinence) or abnormal radiographic or laboratory findings such as new-onset hydronephrosis or renal insufficiency. Indications for ES alone vs BNI alone vs combined BNI/ES are presently based on urodynamic and radiographic findings that allow for identification of the likely site of obstruction. However, for many patients who underwent intervention earlier in the study period, the default procedure was BNI/ES no matter what was identified radiographically or urodynamically. The level of obstruction was not necessarily identified, and both the external and internal sphincters were incised. ES was performed using a cold knife or electrocautery with an incision at the 12-o’clock position. The incision was made from the midprostatic urethra through the bulbomembranous junction to achieve adequate division of striated muscles of external sphincter. Bladder neck incision was performed with 2 incisions extending from just distal to the ureteral orifices, through the bladder neck, and into the prostatic urethra. If the indication for BNI/ES resolved, then the procedure was defined as a success. Failure of BNI/ES was defined as lack of improvement in regards to the primary indication for intervention or subsequent recurrence during the follow-up period (for a similar or different indication) requiring redo BNI/ES. We also documented all alternative treatments that SCI patients had chosen for impaired bladder emptying.
RESULTS Initial BNI/ES procedures were performed in 97 SCI patients. The success rate of the initial procedure was 52.6%, with a mean durability of 106.6 months (range, 6-372 months). Indications for the initial BNI/ES in the general cohort were elevated bladder pressures: 67 (69.1%), recurrent UTI: 13 (13.4%), AD: 2 (2.1%), elevated PVR: 2 (2.1%), and hydronephrosis: 1 (1%). The reason for BNI/ES could not be identified for the remaining 12 patients (12.4%). Forty-six (47.4%) of those patients had eventual failure of the initial procedure and required redo BNI/ES. Our retrospective data analysis will be focused on these 46 patients who were included in the study cohort. The mean follow-up of these 46 patients was 355.4 months (range, 120-816 months) after injury, with a mean age at injury of 21.8 7.5 years (range, 7-45). Thirty-three patients (71.7%) had cervical and 13 (28.3%) had thoracic-level SCI. The etiology of SCI was gunshot wound: 19 (41.3%), motor vehicle accident: 15 (32.6%), UROLOGY 84 (4), 2014
diving: 8 (17.4%), fall: 2 (4.3%), sport injury: 1 (2.2%), and transverse myelitis: 1 (2.2%). The mean age of our study cohort at the initial BNI/ES was 30.7 10.3 years (range, 16-62 years). The mean elapsed time from injury to the first BNI/ES was 109.5 116.0 months (1-660 months), and the mean follow-up after the last BNI/ES was 119 months (6-408 months). Bladder management of patients before the initial procedure was external condom catheter in 29 (63.0%), CIC with external condom catheter in 8 (17.4%), indwelling catheter (urethral or suprapubic) in 4 patients (8.7%), and unknown bladder management in 5 of 46 patients. Indications, success rates, and durability of initial BNI/ ES and the following redo procedures are noted in Figure 1. The success rates of the initial BNI/ES and the following 3 redo procedures ranged between 50.0% and 85.7%. The mean durability of success after BNI/ES ranged between 105.6 and 148.0 months and was significantly longer (P <.05, t test: 2-tailed, unpaired) than the mean time to failure at each level of redo procedure (range, 24-72.8 months; Fig. 1). The most common indications to perform a redo BNI/ES were elevated PVR (first and third redo procedures) and recurrent UTI (second redo procedure; Fig. 1). The various interventions performed at each redo procedure are shown in Figure 2. The most common procedure at the time of the first and second procedures was BNI/ES followed by ES. The most common procedure at the time of the third redo procedure was ES followed by BNI/ES. There were few complications noted perioperatively in any of these patients no matter how many procedures were required. The most commonly noted event was postoperative bleeding; yet, none of the patients studied required a blood transfusion. Urosepsis was noted in 1 patient after the first redo procedure; this occurred despite appropriate antibiotic therapy for a positive urine culture that was obtained and treated preoperatively. Most patients had normal renal and bladder U/S results throughout their follow-up period. A total of 3 patients had hydronephrosis at some point during follow-up, which improved in 2 of these patients after the first redo intervention. One patient with hydronephrosis before his second repeat procedure showed improvement after BNI/ES. Bladder stones were noted in 3 patients preoperatively at some point during the follow-up; those patients underwent cystolitholapaxy at the time of BNI/ES without evidence for recurrent stones with further follow-up. Preoperative urodynamic findings included DESD/ DISD with neurogenic detrusor overactivity (NDO) before the first 3 redo interventions in 84.2%, 88.9%, and 75% and decreased bladder compliance bladder in 10.5%, 22.5%, and 25% of patients, respectively. The mean serum creatinine level of the study cohort at the end of the follow-up was 0.51 0.18 (0.3-1.1). In our study cohort, 1 patient who had failed redo BNI/ ES and was not interested in an indwelling catheter chose 941
Initial BNI/ES = 97 (100%) patients Elevated bladder pressures = 67(69.1%) History of Recurrent UTIs=13(13.4%) History of Elevated PVR=2(2.1%) AD=2(2.1%) Hydronephrosis=1(1.0%) Unknown=12(14.2%) FAILURE
SUCCESS Mean Durability= 106.6 (6-372) months
Mean Durability= 72.8 (6-300) months
Revision #1 BNI/ES = 46 (47.4%) patients Elevated bladder pressures =11(23.9%) History of Recurrent UTIs= 11(23.9%) History of Elevated PVR=15(32.6%) AD=0 (0%) Hydronephrosis=3(6.5%) Unknown=6(13.1%)
SUCCESS 51 (52.6%) patients
SUCCESS
FAILURE
Mean Durability= 105.6 (12-408) months
Mean Durability= 70.4 (2-216) months
Revision #2 BNI/ES = 23 (50.0%) patients Elevated bladder pressures =4(17.4%) History of Recurrent UTIs=8(34.8%) History of Elevated PVR=2(8.7%) AD=5(21.8%) Hydronephrosis=1(4.3%) Unknown=3(13.0%)
SUCCESS 23 (50.0%) patients
FAILURE
SUCCESS Mean Durability= 115 (6-336) months
Mean Durability= 65 (12-192)
Revision #3 BNI/ES = 7 (31.8%) patients Elevated bladder pressures =0(0%) History of Recurrent UTIs=2(28.6%) History of Elevated PVR=4(57.2%) AD=1(14.2%) Hydronephrosis=0(0%) Unknown=0(0%)
SUCCESS 15 (68.2%) patients
SUCCESS
FAILURE
Mean Durability=148 (12-288) months
Mean Durability=24 months
Revision #4 BNI/ES = 1 (14.3%) patients Elevated bladder pressures = 1 (100%)
SUCCESS 6 (85.7%) patients
Figure 1. Indications for BNI/ES and the durability of each procedure. AD, autonomic dysreflexia; BNI/ES, bladder neck incision with or without external sphincterotomy; UTI, urinary tract infection.
to proceed with ileovesicostomy and bladder neck closure. In addition, 7 patients had an intervention before their initial BNI/ES: 5 UroLume (American Medical Systems, Minnetonka, MN) stent placements and 2 internal urethrotomies.
COMMENT A total of 46 patients underwent at least 1 redo BNI/ ES, with a success rate ranging between 50.0% and 85.7% at the first 3 redo procedures. Mean durability of BNI/ES was significantly longer after a successful 942
intervention compared with a failed procedure. The primary indications for BNI/ES were elevated bladder pressures, history of elevated PVR, and history of recurrent UTI. The most common urodynamic findings before BNI/ES included normal compliance, NDO, and DESD/DIESD. Most patients maintained normal upper tracts during the follow-up period, as evaluated by yearly renal U/S. The main goal in the treatment of SCI patients with DESD is the maintenance of low detrusor storage pressures, adequate emptying of the bladder, and prevention of problems such as recurrent UTI, AD, and UROLOGY 84 (4), 2014
35 BNI/ES
ES
BNI
UNKNOWN
30 25 20 15 10 5 0
REVISION REVISION REVISION REVISION REVISION PROCEDURE PROCEDURE PROCEDURE PROCEDURE PROCEDURE #1 #2 #3 #4 #5
Figure 2. Types of interventions at revision bladder neck incision with or without external sphincterotomy.
renal insufficiency. The gold standard treatment is CIC. Bladder management options for patients who are not able or willing to perform CIC include use of an indwelling catheter, reflex voiding to a condom catheter, often in association with a blockers,1 BNI/ES,2-6 urethral stent (permanent/reversible),7-9 or intrasphincteric injection of botulinum toxin10-13 and in rare cases lower urinary tract reconstruction. Surgical sphincterotomy can be performed with knife electrode, resection with a loop, or via laser ablation. Potential indications for sphincterotomy include elevated detrusor pressures, recurrent UTI and urosepsis, AD, elevated PVR, and upper tract deterioration; thus, the definition of success is not the same for all patients evaluated. This can be a challenge when evaluating the outcome of this procedure as the definition of success may not be the same from patient to patient as the indication for the surgery may vary from patient to patient. In previous reports, long-term success with a single sphincterotomy has not been maintained in 40%60% of patients. Pan et al16 cites an initial BNI/ES success rate of 32%. Failure of the initial BNI/ES was managed by redo BNI/ES in 53% of patients with the remaining 47% of patients managed by an alternative treatment. In this series, the authors noted a 43% success rate after the first redo BNI/ES. Only 1 patient subsequently underwent a second redo BNI/ES with the remainder of failures undergoing alternative treatments. The mixture of different procedures during the follow-up after initial BNI/ES, as well as single redo BNI/ES, makes it hard to conclude the outcome of multiple redo surgeries.2,16 Santiago3 reported his initial BNI/ES success rates to be 64% during 10 years of retrospective follow-up. Yang
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and Mayo5 reported a 51% success rate of initial BNI/ ES, but no redo surgeries were reported in this cohort. In the last report, the follow-up period after the surgery was relatively short, and small study cohort could possibly cause bias for initial success rates. Noll et al6 reported the need for redo BNI/ES surgery in 57% of patients. The initial BNI/ES success rate in our series (52.6%) is comparable with previous reports in literature.2-6,16 The mean durability of the initial and redo procedures in our study appears to be longer than what has been previously reported in literature.2-6,16 Pan et al16 reported the mean durability of success after BNI/ES ranging between 68.5 and 71.0 months, which is significantly shorter than that in our study cohort (give our numbers). In addition, their reported median durability from prior BNI/ES to redo procedure was also significantly shorter (36-50 months) than that in our similar cohort (mean, 72.8 months; range, 6-300 months). However, this may be a reflection of our study cohort, which is larger than other reports in literature and from a dedicated neurorehabilitation facility. This may lend itself to easier long-term follow-up as patients tend to continue with their care at our institution after their initial postinjury rehabilitation. Mean time to failure after the initial and subsequent redo interventions at our study cohort was longer than that reported in literature before.2-6,16 It is not clear if this is a reflection of different study populations or different thresholds and indications for reintervention at each institution, impacting the time to failure. Not surprisingly, at each stage, the durability of the procedure was longer in the “success” group compared with the failure group requiring further intervention.
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Success rates of the first 3 redo procedures ranged between 50.0% and 86.7%. In our study, we looked at success based on indication (elevated bladder pressures, elevated PVR, recurrent UTIs, AD, or hydronephrosis) for BNI/ES as did other reports in literature.2,4-6 Like other reports in literature, we could not find an association between indication and likelihood of success or failure. Unfortunately, there was no cutoff time to predict multiple failures and a need to perform redo surgeries. Proposed potential causes for failure include recurrent DESD due to an incomplete resection or fibrotic changes in the area of resection, bladder neck contracture, change in detrusor function (such as NDO, poor contractility, poorly sustained bladder contraction, or poor bladder compliance), change in neurologic function, urethral stricture, and the development of prostatic obstruction.2-6 It is interesting to note that urethral stricture or bladder neck contracture was not found in any of these patients requiring redo BNI/ES. This reflects some of the challenges in treating these patients. Although we do not know what the endoscopic findings would be for the patients who were a success and did not require reintervention, we did not appreciate indicators of anatomic obstruction such as contracture or stricture in this cohort of patients requiring redo BNI/ES. This reflects the likely multifactorial nature of their lower urinary tract dysfunction (both bladder and outlet) and the importance of urodynamics to help with decision making. One of our patients underwent an alternative procedure to BNI/ES during the follow-up. Urethral stent (permanent or temporary) could be an alternative treatment in the failed patients. One of these alternatives is the UroLume, which can be placed at the level of the external sphincter. It has been proven to be an efficient treatment with long-term follow-up.7 Chancellor et al,8 with follow-up >5 years, cited a statistically significant decrease in mean voiding pressure and mean postvoiding residual. AD was found at baseline in 115 of the patients in the study and was resolved in 70% of these at 1 year after stent placement. An additional study prospectively evaluated 40 patients who underwent ES or UroLume placement.9 Urodynamic outcomes were equivalent between the 2 groups; however, the patients who had an UroLume placed had significantly shorter operative time and hospital stays, lower hospitalization costs, and less bleeding than did patients who had had ES. However, there are potential long-term issues with UroLume placement including encrustation, recurrent UTI, overgrowth of granulation tissue, and possible obstruction. Removal of a previously placed UroLume can be very challenging and may lead to complications such as retained wires, urethral injury, and urethrocutaneous fistula.17 The UroLume is presently no longer being produced and is not available commercially for use.
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An indwelling catheter could be an alternative treatment in this subset of patients. However, an indwelling catheter is associated with significant potential morbidity and includes risks of recurrent UTI, hematuria, bladder stones, vesicoureteral reflux, traumatic erosion of the urethra, and bladder cancer.18,19 One option that allows the use of an indwelling catheter but eliminates the potential risk of urethral erosion is use of a suprapubic tube. Indwelling catheters should be changed monthly to reduce risk of recurrent infections. By the study end, 4 of our study cohort patients ended up managing their lower urinary tract with an indwelling catheter (3 suprapubic tubes and 1 urethral catheter). Ileovesicostomy and simple cystectomy with ileal conduit formation are much more involved surgical procedures that are usually reserved for patients who have failed more conservative, less morbid options. Because SCI patients tend to be younger, lower urinary reconstruction may be a reasonable option for patients who wish to avoid the potential consequences of longterm use of an indwelling catheter. 18,19 One patient in our study cohort ultimately underwent ileovesicostomy and bladder neck closure after a failed BNI/ES revision. Although we report the largest series of BNI/ES and redo interventions in literature, our study poses several weaknesses, including retrospective design, missing data, and lack of quality-of-life data. The length of study period is both a positive and a negative. Certainly, the longer study period allows for a greater period of follow-up of these procedures. However, with this longer study period, we have had several urologists practicing with possibly different indications for intervention and possibly different surgical techniques. The change in treatment strategies is reflected in the fact that patients early in the period studied routinely would get a BNI/ES if an intervention was required; presently, we use a combination of clinical history and videourodynamic findings to guide our decision making as to whether the patient would benefit from BNI/ES, ES, BNI, or an alternative procedure. Prospective studies are needed to better understand the outcomes of repeated interventions in the lower urinary tract and their impact on quality of life of SCI patients who are mostly young at their injury and will require long follow-up and multiple procedures.
CONCLUSION Repeat surgery may be necessary for NGB patients managing their lower urinary tract with a combination of reflex voiding to condom catheter drainage after BNI/ES. Success rates ranges from 49% to 86% after 3 repeat BNI/ ES procedures with acceptable long-term durability and low perioperative complication rates. It is important to communicate with patients that repeat surgery or alternative bladder management might have to be explored in case of BNI/ES failure.
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References 1. Consortium for Spinal Cord Medicine. Bladder management for adults with spinal cord injury: a clinical practice guideline for health-care providers. J Spinal Cord Med. 2006;29: 527-573. 2. Juma S, Mostafavi M, Joseph A. Sphincterotomy: long-term complications and warning signs. Neurourol Urodyn. 1995;14:33-41. 3. Santiago JA. Sphincterotomy failure. J Am Paraplegia Soc. 1993;16: 164-168. 4. Vapnek JM, Couillard DR, Stone AR. Is sphincterotomy the best management of the spinal cord injured bladder? J Urol. 1994;151: 961-964. 5. Yang CC, Mayo ME. External urethral sphincterotomy: long term follow-up. Neurourol Urodyn. 1995;14:25-31. 6. Noll F, Sauerwein D, Stohrer M. Transurethral sphincterotomy in quadriplegic patients: long-term-follow-up. Neurourol Urodyn. 1995; 14:351-358. 7. Abdul-Rahman A, Ismail S, Hamid R, et al. A 20-year follow-up of the mesh wallstent in the treatment of detrusor external sphincter dyssynergia in patients with spinal cord injury. BJU Int. 2010;106: 1510-1513. 8. Chancellor MB, Gajewski J, Ackman CF, et al. Long-term follow up of the North American multicenter UroLume trial for the treatment of external detrusor-sphincter dyssynergia. J Urol. 1999;161:1545-1550. 9. Rivas DA, Chancellor MB, Bagley D. Prospective comparison of external sphincter prosthesis placement and external sphincterotomy in men with spinal cord injury. J Endourol. 1994;8: 89-93.
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10. Dykstra DD, Sidi AA, Scott AB, et al. Effects of botulinum A toxin on detrusor-sphincter dyssynergia in spinal cord injury patients. J Urol. 1988;139:919-922. 11. Schurch B, Hauri D, Rodic B, et al. Botulinum-A toxin as a treatment of detrusor-sphincter dyssynergia: a prospective study in 24 spinal cord injury patients. J Urol. 1996;155:1023-1029. 12. Smith CP, Nishiguchi J, O’Leary M, et al. Single-institution experience in 110 patients with botulinum toxin A injection into bladder or urethra. Urology. 2005;65:37-41. 13. Appell RA. Urethral and bladder injections for incontinence including botox. Urol Clin North Am. 2011;38:1-6. 14. Leng WW, Faerber G, Del Terzo M, et al. Long-term outcome of incontinent ileovesicostomy management of severe lower urinary tract dysfunction. J Urol. 1999;6:1803-1806. 15. Ginsberg DA, Rovner ES, Raz S. Complications of urinary diversion. In: Taneja S, Smith RB, Ehrlich R, eds. Complications in Urologic Surgery. Philadelphia: WB Saunders; 2001: 454-467. 16. Pan D, Troy A, Rogerson J, et al. Long-term outcomes of external sphincterotomy in a spinal injured population. J Urol. 2009;181: 705-709. 17. McFarlane IP, Foley SJ, Shah PJ. Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia. Br J Urol. 1996;78:729-732. 18. Hackler RH. Long-term suprapubic cystostomy drainage in spinal cord injury patients. Br J Urol. 1982;54:120-121. 19. Broecker BH, Klein FA, Hackler RH. Cancer of the bladder in spinal cord injury patients. J Urol. 1981;125:196-197.
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