NCT05558111

Brief Summary

Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fMRI).

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 4, 2024

Status Verified

September 1, 2024

Enrollment Period

2.6 years

First QC Date

September 24, 2022

Last Update Submit

November 30, 2024

Conditions

Orthotopic Neobladder

Keywords

Orthotopic neobladderFunctional magnetic resonance imagingNeuroimaging StudyLower urinary tract functionBladder cancer

Outcome Measures

Primary Outcomes (2)

  • The location of brain functional activation areas

    Areas of the brain where excitation or inhibition occurs in fMRI images

    3 months

  • The peak T-value size of the activation region

    Peak T values of activated or inhibited regions of the brain in fMRI images

    3 months

Study Arms (1)

Patients with orthotopic neobladder

Patients with orthotopic neobladder who met the inclusion criteria will be enrolled.Inclusion criteria :(1) being right-handed;(2) 3 months or more after operation;(3) No contraindications to fMIR examination;(4)Does not meet the relevant exclusion criteria.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients 3 months or more after orthotopic neobladder surgery.

You may qualify if:

  • Being right-handed;
  • months or more after operation;
  • No contraindications to fMIR examination;
  • Voluntarily sign informed consent.

You may not qualify if:

  • History of bladder radiotherapy;
  • History of prostate cancer;
  • Suffering from diseases affecting abdominal pressure;
  • History of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy;
  • History of mental disorders, Parkinson's disease, Alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage;
  • Claustrophobia or carrying metal implants that are not suitable for fMRI examination;
  • Diseases affecting lower urinary tract function (such as spinal cord injury, diabetic peripheral neuropathy, etc.);
  • Urethral stricture;
  • Refusing to sign the informed consent form for clinical projects;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Chunxiao Liu

    Southern Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunxiao Liu

CONTACT

13302296795liuchx888@163.com

Yuanxing Huang

CONTACT

13826196384852691657@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor;Chief Surgeon

Study Record Dates

First Submitted

September 24, 2022

First Posted

September 28, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

December 4, 2024

Record last verified: 2024-09

Locations

CN(1)