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Urinary Continence of Female POPRC and OIN

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05325216
Enrollment
58
Registered
2022-04-13
Start date
2022-04-30
Completion date
2028-04-01
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder

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.

Interventions

PROCEDUREPOPRC+OIN

Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

PROCEDURESRC+OIN

Standard radical cystectomy with orthotopic ileal neobladder

Sponsors

Peking University Third Hospital
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
day-time and night-time continence rate6 monthsWe will use pad-test to evaluate the urinary continence for patients

Secondary

MeasureTime frameDescription
perioperative complications rate1 monthsperioperative complications rate within 1 month
overall survival5 years5-year overall survival rate
postoperative sexual function6 monthsInternational index of erectile function-5 (IIEF-5)
operative time24 hoursoperative time (mins)
estimated blood loss24 hoursestimated blood loss (ml)
recurrence-free survival5 years5-year overall recurrence-free survival rate

Countries

China

Contacts

Primary ContactWenlong Zhong, MD
zhongwlong3@mail.sysu.edu.cn86-18510904167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026