World Journal of Urology

, Volume 30, Issue 6, pp 747–752

Perugia ileal neobladder: functional results and complications

Authors

  • Massimo Porena
    • Urology DepartmentUniversity of Perugia
    • Urology DepartmentUniversity of Perugia
  • Alessandro Zucchi
    • Urology DepartmentUniversity of Perugia
  • Michele Del Zingaro
    • Urology DepartmentUniversity of Perugia
  • Ettore Mearini
    • Urology DepartmentUniversity of Perugia
  • Antonella Giannantoni
    • Urology DepartmentUniversity of Perugia
Original Article

DOI: 10.1007/s00345-012-0985-z

Cite this article as:
Porena, M., Mearini, L., Zucchi, A. et al. World J Urol (2012) 30: 747. doi:10.1007/s00345-012-0985-z

Abstract

Purpose

To evaluate the long-term functional results and complications of an orthotopic ileal neobladder, defined as perugia ileal neobladder (PIN), in a group of patients with bladder cancer who underwent radical cystectomy (RC).

Methods

Between 1993 and 2009, 237 consecutive patients who underwent RC for non-metastatic bladder cancer and orthotopic ileal neobladder reconstruction were enrolled. The neobladder was created using a modified Camey-II technique and consisted of a detubularized ileal loop of 45 cm using a vertical “Y” shape. Complications (<90 days) were reviewed and staged according to Clavien–Dindo classification and evaluated at long-term follow-up. Standard monitoring for cancer recurrence (computerized tomography, bone scan), cystourethrography, urodynamics and frequency/volume charts were performed during follow-up.

Results

The median follow-up was 64 months, and the 5-year overall survival rate was 64 %. Early complications were mostly grade I and II; grade III and IV complications were observed in 27 patients. Perioperative mortality rate was 1.6 %. The most frequent late complications were neobladder–ureteral reflux, urolithiasis and urethral anastomotic stricture. Daytime and nighttime urinary continence were 93.5 and 83.9 %, respectively. All patients were able to completely empty neobladders. Twenty patients were followed up for at least 10 years and presented satisfactory functional results.

Conclusions

Surgical morbidity of RC and orthotopic neobladder was significant; however, the rate of grade III–IV complications was low. The long-term functional results of the PIN were interesting, confirming that appropriate patients’ selection, adequate surgical technique, accurate patients’ counseling and follow-up are essential.

Keywords

Bladder cancerIleal neobladderFollow-upClavien–DindoContinenceFunctional results

Introduction

In patients with bladder cancer (BC) who undergo radical cystectomy (RC), orthotopic neobladder (ONB) improves quality of life (QoL) and should, therefore, be the diversion of choice, with most reports assessing long-term functional results and complications [1]. Nevertheless, the lack of prospective randomized studies on the comparison between one over another technique makes difficult to definitively assess the superiority of one specific reservoir [2].

In our department, since the adoption of a Studer-ONB, in 1993, we developed a modification of the Camey-II technique which has been using ever since [3] together with a personal technique for ureteral anastomosis [4].

Here, we report the medium-term functional results and complications of our ONB in a group of patients after RC. In addition, we report the functional results in a small group of patients with at least 10-year follow-up.

Patients and methods

From January 1993 to December 2009, 237 patients underwent RC and ONB for non-metastatic BC.

Inclusion criteria were T2-T3a disease or high-grade recurrent T1 disease and/or carcinoma in situ that were refractory to intravesical therapy [5] and patient’s acceptance of ONB.

Contraindications for ONB were locally advanced or metastatic disease, positive biopsy at bladder neck-prostatic urethra, impaired renal function (glomerular filtration rate, GFR < 90 ml/’), previous pelvic radiotherapy.

General exclusion criteria were significant comorbidity and unwillingness or inability to comply with the voiding behavior required by ONB.

All patients provided written informed consent to ONB using the perugia ileal neobladder (PIN); performance status was evaluated with the Eastern Cooperative Oncology Group (ECOG) classification [6].

All patients underwent extended pelvic lymphadenectomy and RC [7]. ONB was performed by isolating approximately 45 cm of ileum (Fig 1a), starting at 20 cm from the ileocecal valve. Intestinal continuity was restored by using mechanical stapler. The isolated ileal segment was then folded and vertically positioned forming a “Y” shape, as opposed to the original technique in which the loops were horizontally positioned. An incision of approximately 2 cm was made in the lowest part of the Y in order to insert a GIA stapler (Fig. 1b), used to detubularize upward the reservoir. Subsequently, since we use a 60 mm-GIA stapler which is not sufficient to complete detubularization of the reservoir, two other incisions are made along the two “arms” of the Y to insert another one (or two) GIA staplers downwards (Fig. 1b) and, if necessary, upward, thus completing detubularization of the reservoir and leaving the two terminal segments of the loop tubularized, where the ureters are then implanted (Fig. 2a) using an antireflux technique [4] over two ureteral stents. The opening at the lowermost point of the reservoir was then used for the urethral anastomosis (Fig. 2b), avoiding a funnel-shaped outlet to prevent outlet kinking in downward reservoir migration. After catheter insertion, six sutures were used for the urethral anastomosis.
https://static-content.springer.com/image/art%3A10.1007%2Fs00345-012-0985-z/MediaObjects/345_2012_985_Fig1_HTML.gif
Fig. 1

a A 45 cm of ileum is isolated, starting about 20 cm from the ileocecal valve. b The ileal segment is folded and vertically positioned forming a “Y” shape. The GIA stapler is used to detubularize the lowermost part of the reservoir

https://static-content.springer.com/image/art%3A10.1007%2Fs00345-012-0985-z/MediaObjects/345_2012_985_Fig2_HTML.gif
Fig. 2

a Site for ureteral anastomosis, in the upper intact segments of the ‘Y’ shape. b Final shape of the neobladder, with ureteral and urethral site for anastomosis

Ureteral stents were removed on average 14 day and the Foley catheter was removed on day 16–18.

Before discharge, patients receive instructions on how to void while sitting through pelvic floor muscle relaxation performed with a simultaneous Valsalva maneuver [8]. Patients were instructed to void every 3 h during the day, before going to sleep and once or twice during the night.

Patients were followed for cancer control by computerized tomography CT and bone scan every 6 months for the first 2 years and then annually. A cystoscopy was annually checked to rule out urethral recurrence.

Immediate post-operative complications (<90 days) were reviewed and defined using the Clavien–Dindo classification [9], while late diversion-related complications were assessed by using ultrasound scans scheduled every 6 months and by mean of CT; cystourethrography was performed at 6–12 months and yearly to evaluate the upper urinary tract status. GFR was scheduled every 3 months during all the follow-up.

To assess continence status and voiding, urodynamics and one-week frequency/volume charts were completed at 3–6–12 months and then annually.

Urinary continence was graded by the number of daily pads: According to this, continence was defined by the use of no pad or utmost safety pad. Incontinence was defined mild with the use of 1–2 pads, moderate with 3–4 pads and severe with 5 or more pads.

Twenty-four patients who reached 10-year follow-up were also asked to complete the European Organization for Research and Treatment of Cancer 30-item QoL Questionnaire (EORTCQLQ-C30, v3.0) [10]. In addition, using a visual analog scale (VAS) consisting of a 10-cm line marked with “not at all” at the right end and “very much” at the left end, these patients were asked to indicate to what extent bladder problems limited their daily life activities. Visual ratings were then converted to numerical values using a 0–10 scale [11].

Statistical analysis: All calculations were carried out with SPSS release 13.0 (SPSS Inc,Chicago,USA, 2004).

Results

The study population (229 males, 8 females) was relatively young, with a median age of 62.7 years (range 38–78 years). Median follow-up was 64 months (range: 15–149 months). The median operative time was 5.6 h (range 4.2–8.1 h), and median blood loss was 1,100 ml (range 450–3,100 ml); perioperative blood product transfusions were given to 81 patients (34.1 %). Intraoperative complications were rare (1.6 %) and intraoperative mortality rate was 0.4 %. Mean hospital stay was 21 ± 3 days.

The 5-year overall survival rate was 64 %. Causes of death included intraoperative deaths or early complications in 4 (1.6 %), tumor recurrence in 54 patients (22.7 %) and other events such as myocardial infarction or cerebral ischemia in 26 patients (10.9 %).

Early complications (<90 days, Table 1a): One patient died intraoperatively and three suffered fatal complications (myocardial infarction in two and sepsis in one). According to Clavien–Dindo classification of complications, 159 patients (67.0 %) experienced at least a grade I complication. In particular, 63.5 % experienced one or more complications during hospital stay and the remaining after discharge. Overall, there were 159 grade I complications, 117 grade II complications (49.3 %) and 27 grade IIIa–b complications (11.3 %).
Table 1

(a) Early complications (<90 days) according to Clavien–Dindo classification; (b) late complications

Early complications

No. of patients

%

Clavien grade

(a)

Gastrointestinal

 Temporary ileus

24

10.1

I

 Anastomotic bowel leakage

5

2.1

IIIb

Infective

 UTI

11

4.6

II

 sepsis

1

0.4

IVb

Wound

 Wound infection/dehiscence

21

8.8

I

 Fascial dehiscence

2

0.8

IIIa

Genitourinary

 Renal failure

2

0.8

IVa

 Ureteral anastomotic leakage

4

0.4

I

 Ureteral anastomotic stenosis

6

0.6

IIIa

 Urinary retention

15

6.3

II

 Urethral anastomotic stenosis

6

2.5

IIIa

 Urolithiasis

1

0.4

IIIa

Cardiac

 Myocardial infarction

2

0.8

IVa

 Hypotension

59

24.8

I

Pulmonary

   

 Pneumonia

21

8.8

II

 Respiratory distress

6

2.5

II

Bleeding

 Need for blood product transfusion

41

17.2

II

 Bleeding requiring surgery

7

2.9

IIIb

Thromboembolic

 Non-fatal pulmonary embolism

2

0.8

II

 Deep venous thrombosis

5

2.1

II

General

 Death

4

1.7

V

 Acidosis

16

6.7

II

 Others

50

21

I

Late complications

No.

%

(b)

Right ileoureteral reflux

43

13.6

Left ileoureteral reflux

12

3.7

Ureteroileal anastomotic stenosis

8

3.3

Obstruction of neobladder-urethral anastomosis

15

6.3

Neobladder urolithiasis

38

16

Metabolic acidosis and salt-loss syndrome, pyelonephritis and sepsis

16

6.7

Chronic pielonephritis

8

3.3

Conversion to an ileal conduit

1

0.4

Late complications (>90 days, Table 1b): All late complications were diversion-related: temporary neobladder–urethral stenosis in 6.3 %, ureteroileal stenosis in 3.3 %, neobladder urolithiasis in 16.0 %, and acidosis and salt-loss syndrome, pyelonephritis and sepsis in 6.7 %.

Functional results (Table 2): According to the definition, at 3-month follow-up, daytime–nighttime urinary incontinence was mild in 50.2 %, moderate in 38.5 % and severe in 11.2 %. The mean maximum capacity (MC) of the reservoir was 309.4 ± 65.1 ml, and mean post-void residual was 45.7 ml, with no patients requiring intermittent catheterization (IC). At 12-month follow-up, daytime continence rate was 91.3 %, corresponding to an increase in MC, while the rate of nighttime continence was 82.2 %. An indwelling catheter was temporarily needed to empty the bladder in 20 patients who did not comply with the suggested voiding behavior. At a median follow-up of 64 months, daytime continence was 91.7 %, while nighttime continence was 82.2 %, with no patients requiring IC. Mean MC was 391.6 ± 67.4 ml.
Table 2

Functional and urodynamic results during follow-up

Follow-up

3 months

12 months

64 months

120 months

N ° patients

231

231

158

24

Grade of UI

Mild

Moderate

Severe

Mild

Moderate

Severe

Mild

Moderate

Severe

Mild

Moderate

Severe

No. of incontinent patients

116

89

26

6

7

7

4

5

4

8

14

2

Frequency of micturitions

9 ± 2

9.4 ± 3.9

5.1 ± 2.6

9.3 ± 4.7

8.9 ± 2.2

6.3 ± 1.9

8.8 ± 3.9

8 ± 4.9

3.7 ± 4.6

7.4 ± 3.1

7.1 ± 4.0

4.3 ± 3.9

Frequency of daily incontinence episodes

4.1 ± 4

5.7 ± 5.9

7.7 ± 2.2

4.8 ± 4.2

5.6 ± 5.0

6.3 ± 3.2

3.9 ± 4.6

5.8 ± 4.7

5.8 ± 5.4

2.1 ± 0.7

4.3 ± 3.5

5.2 ± 2.8

 

(mean ± SD)

(mean ± SD)

(mean ± SD)

(mean ± SD)

Maximum cystometric capacity (ml)

309.4 ± 65.1

383. 7 ± 85.2

391.6 ± 84.9

421.1 ± 91.5

Maximum flow rate (ml/sec)

18.9 ± 11.6

22.9 ± 9.4

24.6 ± 12.5

23.8 ± 10.4

Post-void residual (ml)

45.7 ± 40.2

37.8 ± 34.2

40.3 ± 22.4

52.5 ± 32.3

The results at 10-year follow-up were available in 24 patients: daytime and nighttime continence was 66.6 %.

According to the EORTCQLQ-C30 questionnaire, the functional scale was mostly affected by lower scores in physical, emotional and social functions. Fatigue, insomnia and financial scores were the main aspects affecting the symptom scale. Mean value of VAS was 7.2 ± 2.8, indicating a good satisfaction of patients’ urinary status.

Upper urinary tract: Voiding cystourethrography documented ureteral reflux in 43 right ureter (13.6 %) and 12 (3.7 %) in the left one. Eight out of 14 patients (8.8 %) with ureteroileal anastomosis obstruction presented with chronic pyelonephritis. Overall, average serum creatinine was 105 ± 21 μMol/L and slightly increased as compared to the pre-operative values of 72 ± 16 μMol/L. The short- and long-term metabolic effects determined by the duration of contact between urine and bowel and by the segment and length of bowel used, together with aging, justify the mean decreases in renal function and GFR (15–25 %) after urinary diversion at long-term follow-up and explain our stringent criteria of a baseline GFR > 90/ml/’. The presence of ureteral reflux did not correlate with a decline in renal function.

The overall incidence of asymptomatic bacteriuria was low (12.2 %) such as the incidence of neobladder infection (2.5 %) which invariably followed neobladder-urethral stenosis, while acute pyelonephritis (2.1 %) occurred in patients with ureteroileal stenosis only.

Discussion

The present study reports good long-term functional results of the ONB using a modified Camey-II technique. The capacity of the Y-neobladder gradually increased over time without becoming oversized, and all patients could void spontaneously with about 2–3 h voiding daytime intervals.

Unlike other studies which report 3–35 % of patients used IC to empty the neobladder [8, 1216]; none of our patients required IC. One of the most important aspects of any neobladder reconstruction is prevention of voiding dysfunctions, and in our series, daytime–nighttime urinary continence rates averaged 91.3 and 82.2 % at 12 months, with a slight increase throughout the observation period, reaching a MC of about 390 ml, stable over time. The characteristics of the neobladder together with frequent bladder empting may have contributed to the achievement of high rates of continence, similar to reports of several other types of ONB: In other studies, 75–100 % of patients were daytime continent [8, 15, 17] and 50–90 % during the night [8, 12, 15, 18]. Moreover, as in other studies [19], we observed a gradual increase in MC overtime, which may have been a factor in reducing the risk of urinary incontinence. Another factor influencing urinary continence is that all patients were instructed to void every 3 h during the day and once twice during the night. The last rule justifies the high rate of nighttime continence, which was at the expense of some fatigue and insomnia, which were the main aspects affecting the symptom scale of EORTC questionnaire. Patients’ satisfaction as assessed by VAS was good in most of these patients and QoL was overall satisfactory.

In our study, we observed a 13.6 % rate of right ureteral reflux and 3.7 % rate of left ureteral reflux, which are comparable to other experience [20], with a slight increase overtime of serum creatinine, comparable to those previously reported [2123].

The vertical “Y” shape and the relatively small size of the reservoir prevent post-void residual and the need for IC [2428], thus preventing long-term acidosis.

Despite our good long-term functional results, we have to admit they may risk being overestimated as validated questionnaires on urinary incontinence were not used [12].

The complications rate was acceptable and similar to other experience with different ONB [29, 30]. Some early complications are not diversion-related, although bowel manipulation and the longer operative time required by ONB should cause some of these. Some other early complications (11.8 %, mostly Clavien grade I-II) were clearly related to urinary diversion (temporary ileus, bowel leakage, anastomotic defects). Conversely, all late complications were diversion-related (anastomotic stenosis, reflux, pyelonephritis, urolithiasis, metabolic acidosis). The use of staples, with the aim of reducing operative time, is at expense of a higher incidence of neobladder urolithiasis. However, the overall incidence of neobladder urolithiasis (16 %) is similar to other experience with the use of mechanical staples, and since a cystoscopy, to rule out urethral recurrence, was scheduled for all patients during follow-up, the removal of small stone in mucosal metallic clip was easily performed in outpatient setting.

Some limitations come from the retrospective reviews of the complications which were then reclassified according to Clavien–Dindo, which has been introduced in 2004 only; however, it seems to be the correct way to criticize personal experience and to present a new surgical technique. Other limitation comes from the use of the EORTC QLQ C-30 questionnaire, which is a questionnaire developed to assess the quality of life of cancer patients, and not specific to rule out quality of life of patient with urinary diversion.

Conclusions

The QoL of patient with ONB must be balanced against the risk of early-late complications, which seems to be high with the use of a validated and complete score system. In our experience and according to Clavien–Dindo classification, the short- and long-term morbidity related to RC and ONB is significant and mostly related to major surgery and type of urinary diversion. However, the rate of high-grade (III–IV) complications is low.

The short- and long-term functional results of the perugia ileal neobladder were interesting, confirming that appropriate patients’ selection, adequate surgical technique, accurate patients’ counseling and follow-up are essential and well balanced upon risks.

Acknowledgments

The authors would like to thank Walter Santilli for technical drawings.

Conflict of interest

None.

Copyright information

© Springer-Verlag Berlin Heidelberg 2012