Investigate the correlation between multimodal neuroimaging and urinary dysfunction and brain functional abnormalities
| ISRCTN | ISRCTN11583354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11583354 |
| Secondary identifying numbers | ChiCTR2400092006 |
- Submission date
- 24/03/2025
- Registration date
- 26/03/2025
- Last edited
- 25/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
This study aims to investigate the central nervous mechanism of the occurrence and development of urinary dysfunction. By using multimodal neuroimaging techniques, the researchers hope to explore the correlation between urinary dysfunction and abnormal brain function, which could aid in better clinical decision-making and treatment.
Who can participate?
Patients with various diseases related to lower urinary tract symptoms who were admitted to the outpatient and inpatient departments of the urology department of Wuxi No.2 People's Hospital (Jiangnan University Medical Center) could participate in this study.
What does the study involve?
Participants will undergo multimodal MRI scans and an anxiety scale assessment. The study will use a variety of advanced techniques to examine these samples. As part of the study, participants will undergo a free medical exam.
What are the possible benefits and risks of participating?
Participants will benefit from free medical tests, which can provide valuable health information. There are no risks involved in participating in this study.
Where is the study run from?
Wuxi No.2 People's Hospital (Jiangnan University Medical Center), China
When is the study starting and how long is it expected to run for?
April 2024 to June 2027
Who is funding the study?
The National Natural Science Foundation of China, China
Who is the main contact?
Professor Ninghan Feng, n.feng@njmu.edu.cn
Contact information
Principal Investigator
Wuxi No.2 People's Hospital, Jiangnan University Medical Center, No.68 Zhongshan Road, Liangxi District
Wuxi City, Jiangsu Province
214000
China
 ORCID ID |
0000-0002-0892-6102 |
|---|---|
| Phone | +86 13861892528 |
| n.feng@njmu.edu.cn |
Scientific
Wuxi No.2 People's Hospital, Jiangnan University Medical Center, No.68 Zhongshan Road, Liangxi District
Wuxi City, Jiangsu Province
214000
China
| Phone | +86 18762806797 |
|---|---|
| 77819869@qq.com |
Public
Wuxi Third People's Hospital, No. 585 Xingyuan North Road, Liangxi District
Wuxi City, Jiangsu Province
214000
China
| Phone | +86 18967215772 |
|---|---|
| fusiyi0210@163.com |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Research on the mechanism and clinical application of multimodal neuroimaging to evaluate the correlation between urinary dysfunction and abnormal brain function |
| Study hypothesis | To explore the central nervous mechanism of the occurrence and development of urinary dysfunction. |
| Ethics approval(s) |
Approved 22/04/2024, Medical Ethics Committee of the Wuxi No.2 People’s Hospital, Jiangnan University Medical Center (No.68 Zhongshan Road, Liangxi District, Wuxi City, Jiangsu Province, 214000, China; +86 15152220089; 9862022074@jiangnan.edu.cn), ref: 2024 Y-26 |
| Condition | Patients with urinary dysfunction |
| Intervention | Serum samples were collected from patients with various lower urinary tract symptoms (such as frequent urination, urgency, dysuria and incomplete voiding, etc.), related diseases (including prostatitis, cystitis, overactive bladder, neurogenic bladder, etc.) and healthy control subjects in the clinical setting. Neuro-psychological tests and multimodal neuroimaging were completed, and the differences in morphometry were compared to explore the central nervous system mechanisms underlying the occurrence and development of urinary dysfunction diseases. |
| Intervention type | Other |
| Primary outcome measure | The central nervous system mechanisms underlying the occurrence and development of urinary dysfunction diseases were measured using multimodal neuroimaging scans performed the afternoon after admission. |
| Secondary outcome measures | 1. Anxiety measured using the Hamilton Anxiety Rating Scale (HAM-A) later in the morning of the second day after admission |
| Overall study start date | 22/04/2024 |
| Overall study end date | 30/06/2027 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 160 |
| Participant inclusion criteria | 1. Diagnostic criteria for interstitial cystitis: (satisfy both of the following conditions) 1.1. Pain in the bladder area or frequent urination and urgency 1.2. Intravesical instillation of normal saline to expand the bladder (pressure reaches 80cmH2O and maintained for 3 minutes), observing more than three quadrants with 10 or more bleeding points as positive. 2: Diagnostic criteria for prostatitis: 2.1. Those who meet the diagnostic criteria for chronic prostatitis according to Western medicine 2.2. Disease duration exceeds 3 months 2.3. No oral treatment with other medications within 2 weeks before entering the study cycle 3. Diagnostic criteria for bladder cancer: 3.1. Pathological diagnosis is the gold standard 4. Diagnostic criteria for prostate cancer: 4.1. Pathological diagnosis is the gold standard 5. Diagnostic criteria for overactive bladder (OAB): 1. Urgency score in the OABSS questionnaire is 2 points or above, and the total score is 3 points or above, excluding other pathological causes. Control Group Enrollment Criteria: Healthy examination personnel with age, gender, and education level matched to the refractory lower urinary tract dysfunction patients were selected from our hospital's health examination center using frequency matching. Among them, those with a HAMA scale score > 7 were included in the anxiety control group. |
| Participant exclusion criteria | 1. Patients with urethral stenosis, urinary tract stones, urinary tract infection, urinary tract tumors, or neurogenic bladder 2. Women who are breastfeeding or pregnant 3. Patients with severe heart, liver, kidney, brain, and hematopoietic system diseases 4. Patients with central nervous system infection, head injury, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease, or intracranial tumors 5. Patients who have undergone pelvic surgery for pelvic organ prolapse or urinary incontinence 6. Patients with a family history of genetic diseases, a history of schizophrenia or personality changes, or a history of alcohol/drug dependence 7. Patients who have taken related cognitive-improving drugs 8. Patients with severe heart, liver, kidney, brain, and hematopoietic system diseases, or gynecological diseases such as vaginitis 9. Patients with contraindications to MRI scanning (such as implanted electronic or metal devices) |
| Recruitment start date | 13/11/2024 |
| Recruitment end date | 30/06/2027 |
Locations
Countries of recruitment
- China
Study participating centre
Wuxi City, Jiangsu Province
214000
China
Sponsor information
Hospital/treatment centre
Jiangnan University Medical Center, No.68 Zhongshan Road, Liangxi District
Wuxi City, Jiangsu Province
214000
China
| Phone | +86 13861892528 |
|---|---|
| 9862022074@jiangnan.edu.cn | |
| Website | http://www.wx2h.com/ |
"ROR" |
https://ror.org/0399zkh42 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Ninghan Feng, n.feng@njmu.edu.cn. The data information may include the demographic data of participants and the main indicators of the experiment. This part has been indicated in the informed consent form, and the data will be collected and used after the consent of the participants. The relevant ethics have been reviewed and approved by the Ethics Committee. |
Editorial Notes
24/03/2025: Study's existence confirmed by the Medical Ethics Committee of the Wuxi No.2 People’s Hospital, Jiangnan University Medical Center.
