Urinary Continence of Female POPRC and OIN

Not Applicable

Not yet recruiting

• Conditions: Urinary Bladder Neoplasms; Woman; Urinary Incontinence; Treatment Outcome; Sexual Dysfunction, Physiological
• Interventions: Procedure: POPRC+OIN; Procedure: SRC+OIN

• Registration Number: NCT05325216
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13
• Primary Completion: 2028-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POPRC group	POPRC+OIN	pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
SRC group	SRC+OIN	standard radical cystectomy with orthotopic ileal neobladder

Primary Outcome Measures

Name	Time	Method
day-time and night-time continence rate	6 months	We will use pad-test to evaluate the urinary continence for patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China