Cystitis patients with typical symptoms of cystitis
Conditions
Interventions
test group:Bladder perfusion therapy with recombinant type III collagen bladder repair agent
control group:Bladder perfusion therapy with Sterile sodium hyaluronate solution
Sponsors
THE FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~70 (inclusive), male or female; 2. Cystitis patients with bladder symptoms such as frequent urination, urgency, and suprapubic bladder pain lasting for more than 3 months, and a pain visual analog scale VAS score of 4 or more before enrollment; 3. Patients who voluntarily sign informed consent and are willing to cooperate with researchers to complete relevant treatment, examination, and follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of allergies to collagen components and sodium hyaluronate; 2. Patients with ketamine-related cystitis; 3. Patients with urinary tract stricture disease; 4. Patients with neurological diseases; 5. Patients with tumor treatment-related cystitis within 6 months (inclusive) of finishing tumor treatment (surgery, radiotherapy/chemotherapy); 6. Diuretic drug users, patients with vesicoureteral reflux; 7. Patients who have received or plan to receive cystitis treatment strategies outside the study protocol during the study period in the past 4 weeks; 8. Patients with prostatitis; 9. Patients with positive midstream urine culture; 10. Patients with white blood cells = 50/HP in urine routine examination; 11. Male patients with benign prostatic hyperplasia (BPH) with I-PSS score greater than 7 or maximum urinary flow rate 0 or bladder residual urine volume>10ml; 13. Patients with uncontrolled diabetes; 14. Patients with severe coagulation abnormalities; 15. Patients with severe liver and kidney dysfunction; 16. Women who are pregnant or breastfeeding; 17. Patients who participated in other clinical trials (except registration studies) within 3 months before screening; 18. According to the opinion of the treatment investigator, there are patients with conditions or circumstances that may cause the subject to be at significant risk, may confound the research results, or may significantly interfere with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate at follow-up 1 week after last treatment;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment frequency;Urinary output;Urination frequency; | — |
Countries
China
Contacts
Public ContactKong ChuiZe
THE FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY
Outcome results
None listed