Urinary Continence of Female POPRC and OIN

Study Overview
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Brief Summary
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To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.

Detailed Description
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Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. For standard radical cystectomy (SRC) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . With regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. Pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . Previous studies demonstrated that POPRC might not affect long-term survival and instead improve continence outcomes. However, most of the available studies are retrospective with limited cases in a single center. The current study primarily aims to urinary continence rate and long-term oncological outcomes of POPRC+OIN versus SRC+OIN in a prospective randomized controlled trial.

Official Title
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Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study

Conditions
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Urinary Bladder Neoplasms, Woman, Sexual Dysfunction, Physiological, Treatment Outcome, Urinary Incontinence

Intervention / Treatment
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* Procedure: POPRC+OIN
* Procedure: SRC+OIN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged between 55-75. Patients those who are diagnosed with organ-confined urothelial carcinoma（<pT3） Patients those who are capable for radical cystectomy with orthotopic ileal neobladder. ECOG score between 0-2; Normal renal function; Patients those who volunteer to participate in this study and sign the informed consents. Patients those who are able to cooperate in the study. Exclusion Criteria: Absence of tumour in bladder neck or urethra; Patients thsoe who are diagnosed distant metastasis before surgery. Previous history of malignancy of pelvic organs or surgical resection of pelvic organs; Patients those who are diagnosed with other malignancies.; Patients those who had received pelvic radiotherapy or major pelvic operation. Pregnancy status; Any other conditions that the researcher considers to be excluded from this study

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POPRC group<br>pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder | Procedure: POPRC+OIN<br>* Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder<br>|
| Active Comparator: SRC group<br>standard radical cystectomy with orthotopic ileal neobladder | Procedure: SRC+OIN<br>* Standard radical cystectomy with orthotopic ileal neobladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day-time and night-time continence rate | We will use pad-test to evaluate the urinary continence for patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sexual function | International index of erectile function-5 (IIEF-5) | 6 months | 
| perioperative complications rate | perioperative complications rate within 1 month | 1 months | 
| overall survival | 5-year overall survival rate | 5 years | 
| recurrence-free survival | 5-year overall recurrence-free survival rate | 5 years | 
| operative time | operative time (mins) | 24 hours | 
| estimated blood loss | estimated blood loss (ml) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder