Menu
Not yet recruiting NCT05325216

Urinary Continence of Female POPRC and OIN

No phase Interventional Urinary Bladder Neoplasms Woman Sexual Dysfunction, Physiological Treatment Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: POPRC+OIN, SRC+OIN.
Who it may be relevant to
Registry conditions: Urinary Bladder Neoplasms, Woman, Sexual Dysfunction, Physiological, Treatment Outcome. Basic parameters: 55 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • day-time and night-time continence rate [Time frame: 6 months]
Secondary outcome measures (6)
  • postoperative sexual function [Time frame: 6 months]
  • perioperative complications rate [Time frame: 1 months]
  • overall survival [Time frame: 5 years]
  • recurrence-free survival [Time frame: 5 years]
  • operative time [Time frame: 24 hours]
  • estimated blood loss [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-Sen Memorial Hospital — Guangzhou

Identifiers

NCT: NCT05325216 · 2021-KY-074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗