Clinical trial NCT05325216: Urinary Continence of Female POPRC and OIN
Official title: Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Bladder Neoplasms
Woman
Sexual Dysfunction, Physiological
Treatment Outcome
Urinary Incontinence
Keywords: Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
First posted: 2022-04-13
Enrollment: 58
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Female patients aged between 55-75.
2. Patients those who are diagnosed with organ-confined urothelial carcinoma（\<pT3）
3. Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.
4. ECOG score between 0-2;
5. Normal renal function;
6. Patients those who volunteer to participate in this study and sign the informed consents.
7. Patients those who are able to cooperate in the study.

Exclusion Criteria:

1. Absence of tumour in bladder neck or urethra;
2. Patients thsoe who are diagnosed distant metastasis before surgery.
3. Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;
4. Patients those who are diagnosed with other malignancies.;
5. Patients those who had received pelvic radiotherapy or major pelvic operation.
6. Pregnancy status;
7. Any other conditions that the researcher considers to be excluded from this study

Primary outcomes:
measure: day-time and night-time continence rate
timeFrame: 6 months
Secondary outcomes:
measure: postoperative sexual function
timeFrame: 6 months
measure: perioperative complications rate
timeFrame: 1 months
measure: overall survival
timeFrame: 5 years
measure: recurrence-free survival
timeFrame: 5 years
measure: operative time
timeFrame: 24 hours
measure: estimated blood loss
timeFrame: 24 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
References: