NCT04966130

Brief Summary

The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 9, 2021

Last Update Submit

July 15, 2021

Conditions

Muscle-Invasive Bladder Carcinoma

Keywords

muscle-invasive bladder cancerrobot-assisted radical cystectomyurinary indwelling timecontinence

Outcome Measures

Primary Outcomes (2)

  • Day-time continence rate

    1 year

  • Night-time continence rate

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing robot- assisted radical cystectomy with orthotopic ileal neobladder will be enrolled.

You may qualify if:

  • Patients with pathologically confirmed bladder cancer
  • Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder
  • Complete perioperative clinical data

You may not qualify if:

  • Patients diagnosed with distant metastasis
  • Patients who had urinary incontinence before surgery
  • Patients with unavailable follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jian Huang, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Chen

CONTACT

+86-02034078960chenh585@mail2.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 19, 2021

Study Start

September 1, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

July 19, 2021

Record last verified: 2021-07