Bladder contracture
Conditions
Interventions
Neurogenic bladder:None
End-stage inflammatory bladder disease:None
Sponsors
China Rehabilitation Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years. 2. Patients with a definitive diagnosis of neurogenic bladder or end-stage bladder inflammatory disease. 3. For neurogenic bladder, urodynamic results indicate a reduced safe bladder capacity (ranging from 100 to 250 ml), along with meeting any of the following criteria: intravesical pressure during storage phase >40 cmH2O, bladder compliance <10 ml/cmH2O, severe detrusor overactivity, or vesicoureteral reflux, will undergo bladder augmentation surgery using a biological patch. 4.For end-stage bladder inflammatory disease, a significantly reduced maximum bladder capacity under anesthesia (ranging from 150 to 250 ml) and/or a significantly reduced functional bladder capacity (ranging from 50 to 100 ml), will undergo bladder augmentation surgery using a biological patch. 5. The patient or their legal representative has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.Malignancies of the urinary or other systems that require priority treatment or may interfere with study outcomes. 2. Acute or chronic urinary tract infections, as indicated by abnormal urinalysis or positive urine culture results. 3. Hematologic abnormalities, such as platelet count 1.5). 4. Abnormal liver function, defined as ALT or AST >3 times the upper limit of normal. 5. Women who are pregnant, breastfeeding, or planning pregnancy. 6.Severe cardiopulmonary diseases, including heart failure classified as NYHA Class III or higher, or poorly controlled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg). 7. Uncontrolled metabolic disorders, such as diabetic ketoacidosis. 8. Severe psychiatric disorders, including major depression or schizophrenia. 9. History of or current use of addictive illicit drugs, such as ketamine. 10. Other serious conditions considered by the investigator to make the participant unsuitable for the trial, including uncontrolled infectious diseases or other comorbidities that may interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder capacity ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bladder compliance;International grading system of vesicoureteral reflux (VUR);Hydronephrosis and ureteral dilatation;Serum creatinine;Voiding diary ;Quality-of-life score;The maximum detrusor pressure during the storage phase;Free uroflowmetry;Post-void residual urine;O’Leary–Sant symptom and problem index;Pelvic pain and urgency/frequency patient symptom scale;Visual analogue scale;Global response; | — |
Countries
China
Contacts
Public ContactZhang Peng
China Rehabilitation Research Center
Outcome results
None listed