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

Recruiting

• Conditions: Orthotopic Neobladder

• Registration Number: NCT05558111
• Lead Sponsor: Zhujiang Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-09-24
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-28
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-30
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China