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

Orthotopic Neobladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558111
• Other study ID #: 2022-KY-131-02
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2022
• Source: Zhujiang Hospital
• Contact: Chunxiao Liu
• Phone: 13302296795
• Email: liuchx888[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Orthotopic Neobladder

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The location of brain functional activation areas	Areas of the brain where excitation or inhibition occurs in fMRI images	3 months
Primary	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