Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

Study Overview
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Brief Summary
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To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and nerve sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

Detailed Description
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This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and nerve sparing group. Patient demographic and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Official Title
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Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: nerve sparing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients aged 18 or older. Patients those who are diagnosed with urothelial carcinoma. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder. Patients those who are able to cooperate and complete the follow-up. Patients those who volunteer to participate in this study and sign the informed consens. Exclusion Criteria: Patients thsoe who are diagnosed distant metastasis before surgery. Patients those who are diagnosed with other malignancies. Patients those who had received pelvic radiotherapy or major pelvic operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nerve sparing group<br>Patients will be preverved the neurovascular bundles during the resection of bladder and prostate of the operation. | Procedure: nerve sparing<br>* When resect the bladder and prostate, the neurovascular bundles around the prostate will be preserved.<br>|
| non nerve sparing group<br>Patients will receive standard radical cystectomy (not preserve the neurovascular bundles) during the operation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day-time continence rate | Patients were considered continent when they required 0 or 1 safety pad during the day-time. | 6 months | 
| night-time continence rate | Patients were considered continent when they required 0 or 1 safety pad during the night. | 6 months | 
| postoperative sexual function | The sexual function are evaluated by the International Index of Erectile Function-5 (IIEF-5). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative complication rate |  | 3 months | 
| operative time |  | 24 hours | 
| estimated blood loss |  | 24 hours | 
| overall survival |  | 1 year | 
| recurrence-free survival |  | 1 year |