The Supraspinal Control of Lower Urinary Tract Function in Patients with Orthotopic Sigmoid Neobladder.

November 30, 2024 updated by: Chunxiao Liu, Zhujiang Hospital

Neuroimaging Study of Supraspinal Control of Lower Urinary Tract Function in Patients with Orthotopic Sigmoid Neobladder.

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients 3 months or more after orthotopic neobladder surgery.

Description

Inclusion Criteria:

  1. Being right-handed;
  2. 3 months or more after operation;
  3. No contraindications to fMIR examination;
  4. Voluntarily sign informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The location of brain functional activation areas
Time Frame: 3 months
Areas of the brain where excitation or inhibition occurs in fMRI images
3 months
The peak T-value size of the activation region
Time Frame: 3 months
Peak T values of activated or inhibited regions of the brain in fMRI images
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Chunxiao Liu, Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 24, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-KY-131-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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