Urinary Continence of Female POPRC and OIN

NCT ID: NCT05325216

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2028-04-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

POPRC group

pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

Group Type: EXPERIMENTAL

POPRC+OIN

Intervention Type: PROCEDURE

Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

SRC group

standard radical cystectomy with orthotopic ileal neobladder

Group Type: ACTIVE_COMPARATOR

SRC+OIN

Intervention Type: PROCEDURE

Standard radical cystectomy with orthotopic ileal neobladder

Interventions

POPRC+OIN

Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

Intervention Type: PROCEDURE

SRC+OIN

Standard radical cystectomy with orthotopic ileal neobladder

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Wenlong Zhong, MD

Role: CONTACT

zhongwlong3@mail.sysu.edu.cn

86-18510904167

Facility Contacts

Wenlong Zhong

Role: primary

zhongwlong3@mail.sysu.edu.cn

86-18510904167

Other Identifiers

2021-KY-074

Identifier Type: -

Identifier Source: org_study_id