Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05325216

Urinary Continence of Female POPRC and OIN

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POPRC+OIN

Procedure

Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

SRC+OIN

Procedure

Standard radical cystectomy with orthotopic ileal neobladder

Primary outcomes

  1. day-time and night-time continence rate

    Time frame: 6 months

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

Secondary outcomes

  1. postoperative sexual function

    Time frame: 6 months

    International index of erectile function-5 (IIEF-5)

  2. perioperative complications rate

    Time frame: 1 months

    perioperative complications rate within 1 month

  3. overall survival

    Time frame: 5 years

    5-year overall survival rate

  4. recurrence-free survival

    Time frame: 5 years

    5-year overall recurrence-free survival rate

  5. operative time

    Time frame: 24 hours

    operative time (mins)

  6. estimated blood loss

    Time frame: 24 hours

    estimated blood loss (ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Wenlong Zhong, MD

CONTACT

[email protected]

86-18510904167

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Peking University Third Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.