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Is continent cutaneous urinary diversion a suitable alternative to orthotopic bladder substitute and ileal conduit after cystectomy? 1 Authors: Bashir Al Hussein Al Awamlh1,4, Lily C. Wang1,4, Daniel P. Nguyen1, Malte Rieken2, Richard K. Lee1, Daniel J. Lee1, Thomas Flynn1, James Chrystal1, Shahrokh F. Shariat1,3 and Douglas S. Scherr1 (1) Department of Urology, Weill Cornell Medical College, New York-Presbyterian Hospital, New York, NY (2) Department of Urology, University Hospital Basel, Basel, Switzerland (3) Department of Urology, Medical University of Vienna, Vienna, Austria (4) These authors contributed equally.

Corresponding Author:

Bashir Al Hussein Al Awamlh, M.D. Department of Urology Weill Medical College of Cornell University Office: 212-746-5788 Fax: 212-746-0975 Email: [email protected] 525 East 68th Street, Starr 900 New York, NY 10065 Running head: Outcomes of continent cutaneous urinary diversion Word Count: Abstract: 329; Manuscript: 3330. Key words: Radical cystectomy, urinary diversion, complications, functional outcome, renal function

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bju.12919

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Abstract:

Objective:

• To evaluate functional outcomes of continent cutaneous urinary diversion (CCUD) after cystectomy. • To compare diversion-related complications and long-term renal function in a contemporary cohort of patients undergoing urinary diversion with CCUD, orthotopic bladder substitute (OBS) and ileal conduit (IC).

Patients and Methods: • 322 patients underwent cystectomy and CCUD, OBS or IC from January 2002 to June 2013. CCUD was performed using either a modified Indiana pouch or an appendiceal stoma. • For patients with CCUD, continence status and time intervals between clean intermittent catheterisations at last follow-up were recorded. • For all three diversion types, diversion-related complications and renal function outcome as

determined by the estimated glomerular filtration rate (eGFR) at baseline and at different time intervals after surgery were evaluated. • Multivariate regression analysis was used to evaluate the association of diversion type, baseline variables and diversion-related complications with renal function over time.

Results:

• Of all 322 patients, 73 (23%) received CCUD, 79 (25%) received OBS, and 170 (53%) received IC. • After a median follow-up of 36 months, the continence rate for patients with CCUD was 89%.

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Sixty-four (88%) patients with CCUD were able to catheterise every 4-8 hours and 5 (7%) were able to catheterise every 8-10 hours. • After a median follow-up of 35 months, rates of diversion-related complications were similar among patients who underwent CCUD, OBS or IC. • Patients who received IC had poorer renal function preoperatively than those who received CCUD or OBS. However, at one year after surgery and thereafter, the three groups had comparable renal function. • On multivariate analysis, the type of urinary diversion was not associated with decline in renal function. However, patient age at surgery, diabetes mellitus, baseline eGFR, postoperative non obstructive hydronephrosis and uretero-enteric stricture were associated with decline in renal function.

Conclusions: • CCUD is associated with excellent functional outcomes. • Rates of diversion-related complications and renal function outcomes are comparable with those from OBS and IC. • CCUD should be considered a valid alternative for patients who undergo cystectomy and require urinary diversion.

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1. Introduction Radical cystectomy (RC) mandates urinary diversion in patients with at least one renal unit.

Although the use of continent urinary diversions, including orthotopic bladder substitution (OBS) and continent cutaneous urinary diversion (CCUD), is increasing in popularity,[1] only 9% of urologists perform continent urinary diversions of any kind after cystectomy. This practice

pattern reflects the complexity of such procedures for both the physician and patient. [2, 3] Several preoperative variables dictate the type of urinary diversion that can be performed;

mainly local tumor status, renal, hepatic and intestinal function and capability to perform clean intermittent catheterisation (CIC) or pelvic training.[4] Patients’ preferences are also taken into account. For instance, the prolonged training required to achieve continence with OBS may

seem tedious to some and sway them to opt for a CCUD. Data on OBS outcomes from the

University of Bern showed that continence might require 6 to12 months to reach an optimum level.[5]

To date, data on long term functional outcomes of CCUD are limited.[6, 7] Moreover, most

studies evaluating complications of urinary diversion have reported on a single type of diversion

and comparative studies are lacking. Perhaps the most important aspect of CCUD, its impact on long-term renal function, has not been comprehensively described.[8-11] To address these issues, herein we report functional outcomes of one of the largest contemporary series including CCUD. In addition, we present a comparative analysis of our experience with CCUD, OBS and IC in

terms of diversion-related complications and renal function.

2. Patients and Methods

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2.1 Patient population After institutional review board approval, we identified 405 consecutive patients who

underwent cystectomy with urinary diversion by a single surgeon between January 2002 and June 2013. Eighty-three (20.5%) patients who had postoperative follow-up less than 90 days

and/or who had no serum creatinine levels available for analysis were excluded. The remaining 322 (79.5%) patients were included in the analysis. Of these, 289 (90%) underwent RC for bladder cancer, while the remainder had other malignancies involving the bladder (3%) or nonmalignant indications (7%).

Follow-up was offered every 3-4 months the first year, semi-annually for the second year, and annually thereafter, and consisted of office visits with review of general health, physical examination, complete blood count and serum chemistry evaluation. Diagnostic imaging (kidney

ultrasound, computed tomography abdomen/pelvis and chest radiography) was performed at least annually or when clinically indicated. Regular correspondence with patients and their

primary physician ensured that treatment received outside of our institution was accounted for in our database. For our analysis, perioperative chemotherapy was defined as either neoadjuvant or adjuvant chemotherapy.

2.2 Operative technique In general, with all patients, the 3 types of diversions and their inherent advantages and

disadvantages were discussed, and the decision was ultimately made at the discretion of the patient and the surgeon. For instance, patients with a high eGFR and/or low performance status were recommended ileal conduits, but the options of OBS and CCUD were also presented. eGFR did not dictate the choice between OBS and CCUD. In this case, CCUD was preferentially

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offered to older patients and/or those who were more likely to be incontinent after OBS, based on baseline lower urinary tract symptoms. Moreover, OBS was discouraged in patients with a history of pelvic irradiation, as its association with complications including urethral strictures and incontinence has been well described.[12, 13] On the other hand, local tumor status and

patient habitus did not influence the choice of diversion in our patients. Regarding CCUD, the choice between appendiceal stoma and modified Indiana pouch

depended on whether the patient still had the appendix and whether it exhibited sufficient length, which was determined intraoperatively. In case of suitable appendix, the right colon was

detubularised along the antimesenteric border and a trough was made in the taenia overlying the cecum (Figure 1). Windows were created in the mesentery of the appendix. The appendix was tested to accommodate a 14fr catheter. Using silk sutures, the appendix was buried in the trough of the cecum with sutures passing through the mesentery of the appendix so as to not compromise its blood supply. The appendix was serially tested with the 14fr catheter to assess ease of passage. Once the trough was closed over the appendix, both ureters were anastomosed to the terminal ileum in antirefluxive fashion. The remaining pouch was closed and the continent

mechanism was tested by filling the pouch to capacity and assessing for leakage from the

appendiceal stoma. This reservoir resembles a Charleston pouch with modifications [14]. When the appendix could not be used, a modified Indiana pouch was constructed [15]. OBS and IC

were performed using previously described techniques [7, 16]

2.3 Outcomes measures 2.3.1 Functional outcomes of CCUD

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Continence rates and time intervals between CICs at last follow-up were prospectively

recorded. Urinary continence was defined as absence of urine leakage between selfcatheterisations.

2.3.2 Diversion-related complications after urinary diversion Diversion-related complications included nonobstructive hydronephrosis, uretero-enteric (UE)

stricture, pyelonephritis (≥ 1 episode), recurrent urinary tract infection (UTI) (≥ 3 episodes per year), stomal stenosis, parastomal hernia, urolithiasis and late pouch perforation. Nonobstructive hydronephrosis was defined as a distended intrarenal collecting system on imaging without

evidence of UE stricture or other mechanical obstruction. Definitive diagnosis of nonobstructive hydronephrosis was concluded after additional investigations with radioisotope renography failed to show obstruction and conduitography or pouchography confirmed bilateral ureteral reflux from conduit or pouch, respectively. Of note, UTI was designated as a positive urine culture in association with foul smelling urine and/or fever. A positive urine culture in the absence of foul smelling urine or fever was not considered an infection and no antibiotics were

given.

2.3.3 Renal function Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Disease

Kidney Epidemiology Collaboration (CKD-EPI) equations.[17] Baseline eGFR was calculated from creatinine readings taken one month prior to surgery. Baseline and postoperative Chronic Kidney Disease (CKD) stages at last-follow-up were assigned according to the National Kidney Foundation guidelines.[18] Change in eGFR from baseline to last-follow-up was calculated by

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subtraction. A decline in renal function was defined as a >10 ml/min/1.73m2 decline in eGFR associated with a increase from chronic kidney disease (CKD) stage 1 or 2 to 3 or higher, 3 to 4, or progression to end stage renal disease (ESRD), for at least a three month period. For more detailed analysis of renal function over time, we defined intervals that correspond to time-points of interest after surgery; eGFR for a given time point was calculated using the median of all readings taken within the given interval. The interval for the 6-month time-point was from 90 days to 9 months after surgery, for the 1-year time-point it was 9 months to 18 months, and for subsequent time points, 6-month intervals were used.

2.4 Statistical analysis Descriptive analyses were performed using the χ2, Mann-Whitney U, and Kruskal-Wallis tests

(SPSS® 21, IBM Corporation, Armonk, NY). The rates of renal function decline were assessed using the Kaplan-Meier method and log-rank test. Hazard ratios (HR) with 95% confidence intervals (CI) of decline in renal function were evaluated through a multivariate Cox proportional

hazards model. Potential confounders included in the multivariate analysis were type of urinary diversion, patient gender and age at surgery (continuous), hypertension, diabetes, baseline eGFR (1ml/min/1.732 increase), perioperative chemotherapy, postoperative nonobstructive hydronephrosis, pyelonephritis, UE stricture, recurrent UTIs and urolithiasis.

3. Results

3.1.1 Clinicopathological and perioperative variables of the study patients Clinicopathological features and perioperative outcomes are summarised in Table 1. Of 322

patients, 152 (47%) received a continent diversion and 170 (53%) received an IC. Specifically,

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73 (23%) patients received CCUD and 79 (25%) received OBS. Of the 73 patients receiving CCUD, 58 (79.5%) and 15 (20.5%) received a modified Indiana pouch and an appendiceal stoma, respectively. Women were more likely to receive CCUD (p = 0.006). Patients who received OBS were the youngest with a median age of 62 years (p

Is continent cutaneous urinary diversion a suitable alternative to orthotopic bladder substitute and ileal conduit after cystectomy?

To evaluate functional outcomes of continent cutaneous urinary diversion (CCUD) after radical cystectomy (RC) and to compare diversion-related complic...
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