Urinary Continence of Female POPRC and OIN

Urinary Incontinence Clinical Trial

Official title:

Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05325216
• Other study ID #: 2021-KY-074
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: April 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Wenlong Zhong, MD
• Phone: 86-18510904167
• Email: zhongwlong3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• POPRC+OIN
Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
• SRC+OIN
Standard radical cystectomy with orthotopic ileal neobladder

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	day-time and night-time continence rate	We will use pad-test to evaluate the urinary continence for patients	6 months
Secondary	postoperative sexual function	International index of erectile function-5 (IIEF-5)	6 months
Secondary	perioperative complications rate	perioperative complications rate within 1 month	1 months
Secondary	overall survival	5-year overall survival rate	5 years
Secondary	recurrence-free survival	5-year overall recurrence-free survival rate	5 years
Secondary	operative time	operative time (mins)	24 hours
Secondary	estimated blood loss	estimated blood loss (ml)	24 hours