Urinary Continence of Female POPRC and OIN

NCT05325216 | Not Yet Recruiting

• 1 other identifier: 2021-KY-074
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• day-time and night-time continence rate

  We will use pad-test to evaluate the urinary continence for patients

  6 months

Secondary Outcomes (6)

• postoperative sexual function

  6 months

• perioperative complications rate

  1 months

• overall survival

  5 years

• recurrence-free survival

  5 years

• operative time

  24 hours

Study Arms (2)

POPRC group

EXPERIMENTAL

pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

Procedure: POPRC+OIN

SRC group

ACTIVE COMPARATOR

standard radical cystectomy with orthotopic ileal neobladder

Procedure: SRC+OIN

Interventions

POPRC+OIN PROCEDURE

Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

POPRC group

SRC+OIN PROCEDURE

Standard radical cystectomy with orthotopic ileal neobladder

SRC group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Peking University Third Hospital: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Sexual Dysfunction, Physiological; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenlong Zhong, MD

CONTACT

86-18510904167; zhongwlong3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)