Unilateral cutaneous ureterostomy with separate stomata vs ileal conduit after radical cystectomy

Abstract

BACKGROUND

Urinary diversion (UD) after radical cystectomy (RC) is a complex surgery that has effects on different patient aspects. The optimal UD method should be technically simple, functionally effective, and socially satisfying. The persistent controversy over the optimal method of UD is the rationale for conducting this study, given the characteristics of the population in our region. Simple UD methods include ureterocutaneous and ileal conduit (IC).

AIM

To compare the surgical outcomes and to identify the factors influencing quality-of-life (QoL) after RC with cutaneous ureterostomy (CU) with separate stomata or IC.

METHODS

A prospective non-randomized study was performed on patients who underwent RC from October 2020 to March 2022. The demographic and clinical characteristics and QoL were compared in patients with IC and unilateral CU with separate stomata. The primary outcome was the difference in the QoL scores between patients with CU (group A) and those with IC (group B). QoL was assessed 6 months after surgery, using the validated Functional Assessment of Cancer Therapy-Bladder questionnaire.

RESULTS

This study included 32 patients with a median age (range) of 61 (48-83) years and a median (range) body mass index of 23.95 (19.2-30.2) kg/m². Wound infections (68.8%) and paralytic ileus (50%) were the commonest complications. The mortality rate was 18.8%, and the main cause was septicemia. The median time of the shunt procedure was significantly longer in group B (P < 0.001). Also, the postoperative anemia (P = 0.029), the days between appliance base changes (P < 0.001), and the rate of febrile urinary tract infections (P = 0.017) were higher in group A. However, the score of QoL (P = 0.025) and survival rate (P = 0.004) were significantly better in group B than in group A. The median QoL score for group A was 68 (52-90) while the median QoL score for group B was 80.50 (62-103) (P = 0.029). Serum creatinine level (P = 0.045), recurrent urinary tract infections (P = 0.025), and the number of re-interventions (P = 0.010) had a significant inverse association with QoL. However, the estimated glomerular filtration rate showed a significant proportional relation (P = 0.006).

CONCLUSION

Unilateral CU with separate stomata may be associated with higher rates of postoperative anemia and urinary tract infections. However, IC seems to be associated with better QoL and febrile urinary tract infections. Increased serum creatinine level, recurrent infections, and re-interventions may influence the QoL score. Unilateral CU with separate stomata may still represent an option for patients undergoing RC.

Key Words: Bladder cancer; Cutaneous ureterostomy; Ileal conduit; Quality of life; Radical cystectomy; Serum creatinine; Urinary diversion

Core Tip: Radical cystectomy mandates a suitable urinary diversion for patients’ functional and sociocultural capabilities. The current exploratory study compared the cutaneous ureterostomy (CU) with separate stomata and the ileal conduit. CU was associated with higher rates of postoperative anemia and urinary tract infections. However, the ileal conduit seemed to be associated with better quality of life scores and survival rates. Increased serum creatinine level, recurrent urinary tract infections, and re-interventions influenced the quality of life score. In low-resource settings, unilateral CU with separate stomata may represent a viable option for urinary diversion after radical cystectomy.

INTRODUCTION

Radical cystectomy (RC) with pelvic lymph node dissection and appropriate urinary diversion (UD) remains the mainstay of treatment for muscle-invasive bladder cancer (BC) and for high-risk non-muscle invasive disease[1]. UD is a complex surgery that has an impact on different aspects of health, including physical, psychosocial, sexual, activities of daily living, and distress related to body image. The ideal UD should successfully preserve renal function while managing urinary outflow and minimizing morbidity to the patient[1,2]. Although the ileal conduit (IC) is considered the standard method for incontinent UD, it is associated with early bowel-related complications, such as bowel obstruction, prolonged ileus, and anastomotic leak. Also, late complications occur in 25%-60% of patients, comprising ureteroenteric stricture (UES), urinary fistula, and stomal site complications[3,4]. The latter includes stomal stenosis, retraction, prolapse, and parastomal herniation. Cutaneous ureterostomy (CU) may represent the method of choice for elderly and otherwise morbid patients due to its relatively short duration and fewer bowel and metabolic complications. Still, it has a high rate of stomal stenosis, making permanent stenting mandatory[3]. In underserved communities, specialized medical care is not widely accessible[1]. This study hypothesized that unilateral CU with separate stomata could be a viable alternative to IC without significantly negative effects on quality of life (QoL) and long-term outcomes. We aimed to compare the surgical results and QoL following IC and CU and to identify factors influencing QoL with these incontinent UD techniques after RC.

MATERIALS AND METHODS

Study design and settings

A prospective study was performed at our hospital from October 2020 to March 2022. This study included patients with BC who underwent RC with IC or unilateral CU with separate stomata. Exclusion criteria were patients with metastases, solitary kidney, RC with unilateral nephroureterectomy, lost-to-follow-up, perioperative death, and refusal of participation in the study. This study was conducted according to the Transparent Reporting of Evaluations with Nonrandomized Designs statement[5].

Considering the power of the study of 80%, the effect size of 0.9, and a probability value of 0.5, the estimated minimum required sample size was 34 patients. The sample size was calculated using G*power software 3.1.9.2, based on the expected QoL scores in the IC and CU groups. However, based on the local rate of patients undergoing RC and a previous relevant literature[4], the actual recruited sample size was 36 patients. For all patients, a full history was taken for age, smoking, comorbidities (such as hypertension, diabetes mellitus, cardiac, hepatic, or chest diseases), previous transurethral resections of bladder tumors, intravesical BCG, or neoadjuvant chemo- or radiotherapy. A systematic physical examination, including a digital rectal examination to evaluate the bladder mass, was performed. Laboratory workups included complete blood count, serum creatinine (SCr), and random blood sugar. In all cases, imaging studies included ultrasonography, kidney-ureter-bladder radiography, and computed tomography.

According to UD type, patients were divided into two groups: Group A included patients with unilateral CU and separate stomata, while group B included patients with IC. The choice of UD type was based on multiple factors, including the surgeon’s preference, preoperative tumor characteristics, and intraoperative circumstances. Patients with large masses, gross signs of invasion, ureteral dilatation, and unsuitable intestinal conditions for resection had driving factors for choosing CU. Therefore, patients were not randomly assigned to UD surgical approaches.

Operative technique

The stoma site was defined and marked on the skin for both techniques. Group A: All patients underwent unilateral CU as described in previous studies[4]. However, a technical modification was performed, making two small abdominal wall openings for the ureters on one side (Figure 1). Subcutaneous fat was removed, the fascia was incised, and the muscle and peritoneal layers were perforated with blunt artery forceps. The ureters were brought out through two separate stomata with a skin ridge of 0.5-1 cm between them. Ureters were spatulated, fixed to the fascia, and sutured to the skin (Figure 1). Group B: All patients underwent IC, using the Wallace technique for ureteroenteric anastomosis[6].

Figure 1 Unilateral cutaneous ureterostomy with separate stomata at different stages. A: Two separate small abdominal wall incisions are made on the right lumbar region, with a ridge left in between; B: The two ureters are passed through the incisions separately. Note that the ureters are dilated with large-caliber Nelaton catheters as stents; C: The ureters are secured to the skin, and a skin ridge is seen separating the two stomata; D: The collection bag base is applied to the stomata after main wound closure and fixation of tubal drains on the left abdominal side.

The operative time was defined as the time between the start of the skin incision and the finish of skin closure. The UD time was defined as the time from the start of ureteral handling after completing RC and lymphadenectomy till the end of UD. In addition, the amounts of blood loss and transfusion, as well as intraoperative complications, were evaluated.

Postoperative evaluation

Postoperatively, hemoglobin and SCr levels, blood transfusion, hospital stay, hospital readmission, postoperative histopathology, tumor staging, complications, and auxiliary chemotherapy or radiotherapy were evaluated. In addition, the care of stents and the appliance base were studied for the rate of exchange, setting, and caregiver personnel. Follow-up was scheduled every three months: SCr, estimated glomerular filtration rate (eGFR), urine analysis, and abdominopelvic ultrasonography were performed. Workups for local recurrence and distant metastasis by computed tomography or magnetic resonance imaging were performed 6 months to one year after surgery. In cases of obstruction or infections of the upper tract, imaging was performed at presentation. UES was diagnosed by the presence of symptomatic ureteral obstruction that indicated a nephrostomy tube placement for drainage. No malignant causes could be diagnosed as a cause of obstruction in the imaging of patients with UES. Additionally, urinary tract infection (UTI) was defined as the presence of symptoms related to UTI and positive culture and sensitivity tests.

The QoL was assessed using the validated Functional Assessment of Cancer Therapy-Bladder questionnaire. It includes 27 items divided into 4 domains: Physical, social, emotional, and functional well-being. Additional 12 urology-specific items: 10 items related to urinary, gastrointestinal, and sexual symptoms and 2 questions for patients with urostomy appliances. All items are scored on a Likert scale of 0 “not at all” to 4 “very much” with higher scores indicating better QoL[7]. The questionnaire was filled out by the authors or highly qualified nurses 6 months after surgery.

Study outcomes

The study’s primary outcome was the QoL score in the IC and CU groups. The secondary outcomes were the operative time and complication rates. The early complications (within 90 days) and late complications (≥ 90 days) were classified according to the modified Clavien-Dindo system[8], including low (I, II, and IIIa) and high (IIIb, IV, and V) grades.

Ethical approval

The local ethics committee in our institute approved this study, and the institutional review board approval number is 17101339. In addition, it was registered in ClinicalTrials: No. NCT04610385. All procedures performed in this study were in accordance with the Helsinki Declaration and its amendments. Informed consent was obtained from all the participants in the study.

Statistical analysis

Statistical analysis was performed using the statistical package for the social sciences, version 20.0 (SPSS Inc., Chicago, IL, United States). Quantitative data were expressed as median and range and analyzed by the Mann-Whitney U Test. In contrast, qualitative data were expressed by n (%) and analyzed by Fisher’s exact test. We compared the two groups regarding preoperative, operative, and postoperative data. Factors affecting the QoL were analyzed using simple linear regression. A descriptive Kaplan-Meier survival analysis was performed for patients in the two groups. A P-value of 0.05 was considered statistically significant.

RESULTS

The current study included 32 patients who underwent RC (Figure 2). Unintentionally, 16 male patients were included in each group A (unilateral CU) and group B (IC). The median age (range) was 61 (48-83) years with a median (range) body mass index of 23.95 (19.2-30.2) kg/m². Transitional cell carcinoma was the histopathology in 19 (59.4%) patients. The operative and postoperative characteristics of all patients are demonstrated in Table 1. The most common complication was wound infections documented in 22 (68.8%) patients, followed by paralytic ileus in 16 (50%) patients. The overall incidence of early postoperative complications (< 90 days) was not different between the two groups; They occurred in 15 (93.75%) patients with CU vs 16 (100%) patients with IC (P > 0.999). However, the late complications (≥ 90 days) included febrile UTIs, which were significantly higher in patients with CU (P = 0.017), and the number of surgical reinterventions, which were similar in both groups (P > 0.999). The rate of mortality was 18.8%, and the main cause was septicemia (Table 2).

Figure 2 Flowchart of patients who underwent radical cystectomy and urinary diversion. It shows the flow of patients who received either an ileal conduit or a unilateral cutaneous ureterostomy with separate stomata.

Table 1 Demographic and clinical characteristics of all patients, median (range)/n (%).

Variables	Value
Age (years)	61 (48-83)
BMI (kg/m2)	23.95 (19.2-30.2)
eGFR (mL/minute)	97.5 (16-117)
Hemoglobin (g/dL)	12.25 (9-16.3)
Serum creatinine (mg/dL)	0.9 (0.5-3.9)
Smoking	23 (71.9)
Medical comorbidities	12 (37.5)
Tumor stage
T1	8 (25)
T2	17 (53.1)
T3	7 (21.9)
Tumor histopathology
TCC	19 (59.4)
Squamous cell carcinoma	3 (9.4)
Adenocarcinoma	1 (3.1)
TCC with variants	9 (28.1)
Neoadjuvant therapy
Chemotherapy	7 (21.9)
Radiotherapy	2 (6.3)
Intravesical BCG	4 (12.5)
Comorbidities
Diabetes	7 (21.9)
Hypertension	5 (15.6)
Cardiac	1 (3.1)
COPD	2 (6.3)
Operative characteristics
Operative time (minutes)	357.5 (250-500)
Operative time for shunt (minutes)	100 (40-165)
Blood loss (cc)	925 (600-2000)
Blood transfusion (Units per patient)	2 (1-4)
Postoperative day-1 hemoglobin level (g/dL)	10.6 (7.7-13.6)
Postoperative day-1 serum creatinine level (mg/dL)	1.1 (0.6-3.3)
Number of retrieved lymph nodes	18 (4-39)
Incidence of perioperative complications	31 (96.95)
Complication grade
Low or no complications	25 (78.1)
High	7 (21.9)
Hospital stay (days)	12 (3-55)
Follow-up
Duration (months)	10 (6-24)
Serum creatinine (mg/dL)	1.1 (0.8-4.1)
eGFR (ml/minute)	74 (14-101)
Days between appliance base changes1	10 (5-25)
QoL score	71 (52-103)
Febrile UTI	9 (36)

¹The higher the number of days between changes of the appliance base, the lower the frequency of changes. This was an advantageous finding because it meant that the appliance is durable and long-lasting with lower costs.

BMI: Body mass index; eGFR: Estimated glomerular filtration rate; TCC: Transitional cell carcinoma; BCG: Bacillus-Calmette-Geurin; COPD: Chronic obstructive pulmonary disease; QoL: Quality-of-life; UTI: Urinary tract infection.

Table 2 Summary of perioperative complications (< 90 days), their grades, and management.

Complication1	n (%)	Grade	Management
Rectal injury	1 (3.1)	3b	Intra-operative repair
Paralytic ileus	16 (50)	1; 2	Five patients underwent conservation; 11 patients required medications
Severe anemia	7 (21.9)	2	Blood transfusion
Lymphorrhea	5 (15.6)	1	Conservative management
Lymphocele	1 (3.1)	3a	Conservative management
Fecal fistula	3 (9.4)	3b	Re-exploration
Wound infection	22 (68.8)	1	Daily dressing with antiseptics
Burst abdomen	6 (18.8)	3b	Surgical re-closure
Pneumonia	1 (3.1)	2	Medical treatment
Early stent slippage	2 (6.3)	1; 3a	One patient had bilateral stent slippage POD 13 and underwent conservation (group B); one patient from group A showed left stent slippage POD 32, which was associated with a burst abdomen and fecal fistula, and underwent PCN insertion
Anastomotic urine leakage and intestinal obstruction	1 (3.1)	5	Death
Thromboembolism	2 (6.3)	4a; 5	One patient was entered in a vegetative state; one death
CVD	1 (3.1)	5	Heart failure and death
Fecal fistula and burst abdomen	3 (9.3)	5	Septicemia and death
Febrile UTI	1 (3.1)	5	Septicemia and death

¹Some patients experienced more than one complication.

CVD: Cardiovascular diseases; PCN: Percutaneous nephrostomy; POD: Postoperative day; UTI: Urinary tract infection.

In comparison between both groups, the median time of the shunt procedure was significantly longer in group B (P < 0.001). Also, the postoperative hemoglobin level (P = 0.029), the days between appliance base changes (P < 0.001), the rate of febrile UTI (P = 0.017), and the score of QoL (P = 0.025) were significantly different in both groups (Table 3). Before six months of follow-up, seven patients experienced high-grade complications, and six of them died (five patients in group A and one patient in group B). The seventh patient was from group B, and he developed a fecal fistula and was re-explored surgically. Then, he developed a cerebrovascular insult after a cardiac arrest, resulting in a vegetative state. These seven patients were excluded from further analysis (Table 2).

Table 3 Comparison between the two groups for the preoperative, operative, and postoperative variables.

Variables		Group A (CU)	Group B (IC)	P value
Age		62 (48-83)	61 (51-73)	0.59
BMI (kg/m2)		24.65 (19.2-29.5)	23.15 (20.8-30.2)	0.468
eGFR (ml/minute)		88.5 (16-113)	98.5 (48-117)	0.287
Preoperative hemoglobin (g/dL)		10.7 (9-14.7)	12.85 (10.5-16.3)	0.056
Preoperative serum creatinine (mg/dL)		1 (0.5-3.9)	0.85 (0.5-1.6)	0.361
Smoking		13 (81.25%)	10 (62.5%)	0.433
Medical comorbidities		6 (37.5%)	6 (37.5%)	> 0.999
Tumor stage	T1	5 (31.25%)	3 (18.75%)	0.445
	T2	5 (31.25%)	12 (75%)
	T3	6 (37.5%)	1 (6.25%)
Tumor histopathology	Urothelial	10 (62.5%)	9 (56.25%)	0.496
	Squamous cell carcinoma	2 (12.5%)	1 (6.25%)
	Adenocarcinoma	1 (6.3%)	0
	Urothelial with variant	3 (18.75%)	6 (37.5%)
Neoadjuvant chemotherapy		4 (25%)	3 (18.75%)	> 0.999
Neoadjuvant radiotherapy		2 (12.5%)	0	0.484
Intravesical BCG		3 (18.8%)	1 (6.3%)	0.6
Operative time (minutes)		360 (250-480)	350 (270-500)	0.985
Shunt time (minutes)		60 (40-110)	122.5 (90-165)	< 0.001
Estimated blood loss (cc)		950 (800-2000)	900 (600-1600)	0.171
Blood transfusion (units)		2 (2-4)	2 (1-4)	0.184
Postoperative hemoglobin level (g/dL)		10.15 (7.7-12.6)	11.05 (8.9-13.6)	0.029
Postoperative serum creatinine level (mg/dL)		1.2 (0.6-3.3)	1 (0.6-1.8)	0.11
Hospital stay (days)		10 (3-33)	13 (9-55)	0.08
Number of retrieved lymph nodes		15.5 (4-28)	20 (8-39)	0.08
Perioperative complications		15 (93.75%)	16 (100%)	> 0.999
Complication grade
No or low grades		11 (68.75%)	14 (87.5%)	0.394
High grades		5 (31.25%)	2 (12.5%)
Days between appliance base changes		15 (10-25)	7 (5-15)	< 0.001
Serum creatinine level at last follow-up (mg/dL)		1.15 (0.9-4.1)	1.1 (0.8-2.2)	0.12
eGFR (mL/minute)		70 (14-100)	78 (33-101)	0.186
Incidence of re-intervention		0.4 (0.699)	0.46 (0.66)	> 0.999
Febrile UTI		7 (63.63%)	2 (14.28%)	0.017
QoL score after 6 months		68 (52-90)	80.5 (62-103)	0.029

CU: Cutaneous ureterostomy; IC: Ileal conduit; BMI: Body mass index; eGFR: Estimated glomerular filtration rate; BCG: Bacillus-Calmette-Guerin; QoL: Quality of life; UTI: Urinary tract infection.

The postoperative staging and histopathology of the remaining 25 patients are listed in Table 4. Seventeen patients received adjuvant chemotherapy, and 10 of them received combined chemotherapy and radiotherapy for cases with T3-4 or positive nodes. However, three patients didn't receive adjuvant therapy due to refusal or unfitness. Eight of these 25 patients developed distant metastasis.

Table 4 The postoperative staging, histopathology, and adjuvant therapy for the remaining 25 patients.

Primary tumor (T)	Regional lymph nodes (N)	Number of patients	Chemotherapy or radiotherapy (n)	Histopathology (n)
T0	N0	1	-	Necrosis
T1	N0	1	-	UC
T2	N0	3	-	UC
T2	N+	3	Two patients received chemotherapy	UC
T3	N0/Nx	7	Chemotherapy (2)	UC (6)
			Combined (4)	SCC (1)
			None (1)
T3	N+	1	Combined	UC
T4	N0/Nx	2	One received chemotherapy	UC (1)
				SCC (1)
T4	N+	7	Chemotherapy (2)	UC (6)
			Combined (5)	Adenocarcinoma (1)

SCC: Squamous cell carcinoma; UC: Urothelial carcinoma.

At 6-month follow-up, the medians of SCr level, eGFR, and days between appliance base changes were 1.1 (0.8-3.9) mg/dL, 79 (15-103) mL/minute, and 10 (3-25) days, respectively. Four patients (16%) experienced febrile UTIs. Only 25 patients survived; 14 in group B and 11 patients in group A. The median QoL score was 71 (52-103); the median QoL score for group A was 68 (52-90), while the median QoL score for group B was 80.50 (62-103) (P = 0.029) (Table 3).

Regarding group B, six (42.85%) patients showed UES. The median (range) duration for the occurrence was 9 (6-24) months and its cumulative incidence at 6 months and 12 months was 10.7% and 7.1%, respectively; one (7.14%) patient had a right-sided UES (developed at 6 months), two (14.28%) patients had a left-sided UES (occurred at 6 and 9 months), and three (21.42%) patients had bilateral UES (occurred at 6 months and 12 months, at 9 months and 12 months, and at 18 months and 24 months), considering that all patients had right-sided stoma. Of these six patients, four received postoperative radiotherapy. Most of these patients presented either with infected hydronephrosis or oliguria and raised SCr or both. The initial management was percutaneous nephrostomy insertion as an emergency. One of these patients underwent a trial of retrograde endoscopic treatment but failed due to complete obliteration of the anastomotic site, and this patient is scheduled for open repair.

Regarding group A, the median of days between ureteric stent exchange was 40 (30-45) days. Four (36.4%) patients were exchanging stents by themselves at home, 4 (36.4%) patients by paramedics at home, one (9.1%) patient at a primary health care center, and only 2 (18.2%) patients were exchanging stents at Assiut University Hospital outpatient clinic according to their preference, without any difficulty. In group A, no patients experienced a ureteric stricture that hindered stent exchange. Regarding factors influencing the QoL, SCr level (P = 0.045), recurrent UTI (P = 0.025), and the number of re-interventions (P = 0.010) had a significant inverse association with QoL. The eGFR showed a significant proportional relation (P = 0.006). Group B showed a significantly higher QoL score than that in group A (P = 0.025) (Table 5). At the end of the study, 15 of 32 patients (46.87%) died within a median time of 190 (3-491) days. In a descriptive Kaplan Meier survival analysis and using the Log-Rank test, there was a statistically significant difference between the two groups in the survival rate (P = 0.004) (Figure 3).

Figure 3 Kaplan-Meier survival analysis, using the Log-Rank test. In comparison to the cutaneous ureterostomy with separate stomata, the ileal conduit was associated with a better survival rate. Owing to the major limitations in this study, these survival analyses should be cautiously handled as an exploratory work.

Table 5 Simple linear regression analysis of factors influencing the quality of life.

Variables1	Unstandardized coefficients	Standardized coefficients (95% confidence interval)	P value
Age (years)	-0.555	-0.288 (-1.351 to 0.241)	0.162
Days between appliance base changes	-0.889	-0.310 (-2.095 to 0.316)	0.14
Number of re-interventions	-11.386	-0.506 (-19.751 to -3.020)	0.01
Serum creatinine level (mg/dL)	-8.148	-0.404 (-16.096 to -0.201)	0.045
eGFR (ml/minute)	0.339	0.544 (0.108-0.570)	0.006
Medical comorbidities	11.533	0.394 (-0.068 to 23.135)	0.051
Postoperative chemotherapy	0.176	0.006 (-13.080 to 13.433)	0.978
Postoperative radiotherapy	-8.967	-0.306 (-20.983 – 3.050)	0.136
Distant metastatic recurrence	-0.743	-0.024 (-13.996 to 12.511)	0.909
Febrile UTI	-13.354	-0.447 (-24.878 to -1.830)	0.025
Type of shunt	-12.773	-0.442 (-23.947 to -1.599)	0.027

¹This simple linear regression was used to withstand the large number of variables influencing the quality of life.

eGFR: Estimated glomerular filtration rate; UTI: Urinary tract infection.

DISCUSSION

The type of UD after RC is planned, considering several factors, such as life expectancy, renal function, patient choice, tumor characteristics, medical comorbidities, gastrointestinal tract status, surgeon experience, and center qualifications[2]. The bilateral CU is considered the simplest shunt with a relatively short time. However, it carries a high complication rate and low QoL scores. So, there are multiple modifications to this shunt to enhance the QoL, such as reimplanting both ureters at one side with a single or separate stomata[4,9]. The common complications of CU are stomal stenosis, making ureteral stenting mandatory, recurrent stent slippage, and increased risk of UTI, leading eventually to renal impairment[9]. Although IC is considered the standard method of incontinent UD, most previous studies have performed CU in elderly patients with advanced disease, mostly performed as a palliative measure[4,9,10]. Given the ongoing debate, we sought to give this diversion another chance, where it may be underrated and can result in a reasonable QoL.

Previous researchers compared only the total operative time, which was significantly longer in patients with IC[10,11]. Additionally, our study compared the shunt time, which was longer in the IC group (P < 0.001). However, the total operative time was nearly equal between the two groups. This finding can be explained by the inherent tendency to perform CU in cases with advanced malignancy, prolonged, difficult cystectomy, and lymph node dissection to avoid more anesthesia time. The possibility of postoperative management of these patients by adjuvant combined chemo and radiotherapy, with possible intestinal and anastomotic complications, was considered.

In the current study, the rate of febrile UTI was significantly higher in the CU group (P = 0.017). However, there was no significant difference regarding renal function. Clifford et al[12] studied UTI rates per type of UD in the first postoperative 90 days and found no significant differences. On the other hand, other studies reported more frequent UTIs in orthotopic bladder substitution (OBS) than in heterotopic diversions[13,14].

The renal function is expected to get worse due to old age, recurrent UTI, use of the intestinal segment, and disease recurrence[15]. While several large-scale reports have compared the postoperative renal function between IC and OBS, few studies have directly compared the postoperative renal function in IC and CU. Suzuki et al[11] documented that recurrent pyelonephritis occurred significantly more often in the CU group than in the IC group, considering it a risk factor for renal deterioration. Hence, CU was identified as a significant predictor of a ≥ 20% decrease in the eGFR[11]. Several studies showed an insignificant difference in patients who experienced renal deterioration post RC among the three different UDs (CU, IC, and OBS)[16-18]. The selection of the UD type relative to the baseline SCr recalls selection bias that may partially mask any real differences in the postoperative renal function. Other various parameters, such as age, hypertension, diabetes, baseline eGFR, urinary tract obstruction, and UTI, have been reported as predictors of postoperative renal function in this category of patients[16]. The short-term follow-up might be a cause of the absence of a significant difference in renal function deterioration between the two groups in our study.

One of the complications developed after RC with IC is UES. The risk of UES development ranges from 2.7% to 10% in high-volume centers, with a median time to discovery of 7-18 months after surgery. Ureteral ischemia and inflammation secondary to excessive dissection and intraoperative handling of the ureters and radiotherapy may be the possible factors for benign stricture development[19]. Nassar and Alsafa[19], Shah et al[18], and Richards et al[20] found that strictures are more likely to occur on the left than the right side (66% on the left and 29% on the right). Although the anastomotic technique is the same bilaterally, the left ureter is usually tunneled under the mesosigmoid and mobilized more proximally to gain adequate length for anastomosis. This increased dissection and mobilization may play a role in the higher left-sided stricture rates because of increased handling and potential compromise of the vascular supply[19-21]. We found a total UES rate of 42.85% that was significantly higher than that reported in the literature (8.8%-14%). The Wallace technique could be blamed for these higher rates. Similarly, Shah et al[18] believed that the Bricker method of ureteroenteric anastomosis could be an important factor in dramatically decreasing the rate of UES. The postoperative radiotherapy in the case of patients with locally advanced disease is mostly accused[20-23].

Arman et al[9] evaluated the QoL between the two groups using the Functional Assessment of Cancer Therapy-Bladder questionnaire with a significantly higher (P = 0.027) median total score of 115.5 (106-123) in IC compared to 108.0 (96-118) in unilateral CU and 101.0 (93-108) in the standard bilateral CU[9]. Also, Moeen et al[1] compared QoL after different types of UD (continent and incontinent) using the same questionnaire, with a mean total score of 77.9 ± 4.4 in CU and 97.9 ± 5.3 in IC[1]. In the current study, we found that the median total score was 78 (56-103) in IC compared to 65.5 (52-92) in unilateral CU (P = 0.025). Our explanation may be the choice of CU as UD for advanced cases. In the current study, SCr level, febrile UTI, and the number of re-interventions were significantly inversely related to QoL, but eGFR showed a significant direct relation.

These techniques of incontinent UD imply the use of external urine bags, which can lead to negative effects on QoL. However, each technique has its inherent advantages and disadvantages. CU is the simplest and least invasive form of UD. Moreover, CU does not require intestinal violation and allows a convenient approach to the upper urinary tract[4,9,10]. The main drawback of CU is stomal stenosis, which has been observed more often with this procedure than with intestinal stoma and requires lifelong ureteric stenting with recurrent febrile UTI, representing a real disadvantage. IC does not require permanent ureteric stenting, but complications related to gastrointestinal tract violation are more frequent[4,9]. Hence, high-risk patients with BC undergoing RC have shown better intra- and early postoperative outcomes when a CU with unilateral stomata was performed rather than with IC.

The limitations of this study included a lack of randomization, a small sample size, and a relatively short follow-up period. Additionally, not having preoperative assessments of QoL as baseline values may render it more difficult to interpret the postoperative differences between the two groups. Furthermore, excluding early deaths and severe complications from the QoL analysis risked biasing results toward the healthier survivors and potentially toward one diversion group. Moreover, reporting median total scores without domain-level analysis limits interpretability. We firmly acknowledge this potential selection bias and present this experience as a descriptive and hypothesis-generating analysis. Accordingly, the current analyses should be handled as exploratory rather than inferential results. However, the prospective nature of the current study, with the discussion of an uncommon modification of CU, can be seen as a strength.

CONCLUSION

The optimal UD type is still a controversial topic. Considering that many patients who belonged to the IC group underwent re-intervention in the form of percutaneous nephrostomy insertion mainly for silent uremia due to lack of medical care with irregular follow-up in developing countries, unilateral CU with separate stomata may be seen as an option besides IC, which is associated with a relatively better QoL and long-term outcomes.