Urinary Continence of Female POPRC and OIN

Sun Yat-sen University

Status: Not yet enrolling

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

Treatments: Procedure: SRC+OIN; Procedure: POPRC+OIN

Study type: Interventional

Funder types: Other

Identifiers

NCT05325216

2021-KY-074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

POPRC group

Experimental group

Description:

pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

Treatment:

Procedure: POPRC+OIN

SRC group

Active Comparator group

Description:

standard radical cystectomy with orthotopic ileal neobladder

Treatment:

Procedure: SRC+OIN