Lower urinary tract disease
Conditions
Interventions
Control group:N/A
Experimental group:Injection of botulinum toxin type A, augmentation enterocystoplasty
Sponsors
China Rehabilitation Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Healthy research participants: (1) Aged 18 to 75 years, regardless of gender; (2) All research participants have signed the written informed consent form; (3) No history of urinary incontinence or other urinary system diseases. 2.BTX-A injection: (1) Aged 18 to 75 years, regardless of gender; (2) All research participants have signed the written informed consent form; (3) Patients with neurogenic detrusor overactivity who are refractory to conservative treatment, or cannot tolerate the adverse reactions of drugs such as M-receptor blockers, with no severe bladder wall fibrosis, and able to accept intermittent catheterization; (4) Patients with refractory overactive bladder who are refractory to conservative treatment or cannot tolerate the adverse reactions of drugs such as M-receptor blockers; (5) Patients with detrusor-sphincter dyssynergia, detrusor underactivity, internal urethral sphincter (bladder neck) relaxation disorder or spasm who are refractory to conservative treatment, or who refuse or are not suitable for intermittent catheterization; (6) Patients with interstitial cystitis/bladder pain syndrome who are refractory to conservative treatment or cannot tolerate drug adverse reactions. 3.Enterocystoplasty (1) Aged 18–75 years, with no restriction on gender. (2) All research participants have signed the written informed consent. (3) Intractable condition after failure of anticholinergic medication, detrusor injection of botulinum toxin type A (BTX-A), and neuromodulation therapy. (4) High bladder pressure during the storage phase (> 40 cmH2O) or decreased bladder compliance (< 10 ml/cmH2O), with or without upper urinary tract damage. (5) High-grade and/or low-pressure vesicoureteral reflux complicated with upper urinary tract damage. (6) Severe upper urinary tract dilatation accompanied by ureterovesical junction stricture. (7) Bladder contracture caused by certain infectious and inflammatory diseases, such as tuberculosis.
Exclusion criteria
Exclusion criteria: 1.Healthy Research Participants: (1) Urinary tract infection, vaginal infection; (2) Those who used antibiotics, antibacterial drugs, etc. within nearly 1 month before enrollment; (3) Metabolic diseases such as diabetes mellitus and obesity; (4) During pregnancy, lactation period and menstrual period; (5) Others. 2.BTX-A: (1) Pregnant women, lactating women, and women of childbearing age planning to become pregnant during the study period; (2) Those with known allergies to the study drug and its components, or those with allergic diathesis; (3) Complicated with clinically unstable severe cardiovascular diseases; (4) Renal insufficiency; (5) Those with liver diseases; (6) Alcoholics or drug abusers; (7) Participants who participated in other drug clinical trials within 1 month before enrollment; (8) Those who received any BTX preparation treatment within 6 months before enrollment; (9) Urinary tract infection; (10) Those with bladder stones, ureteral stones or urethral stones; (11) Patients with bladder cancer or prostate cancer; (12) Complicated with diabetes mellitus; (13) Those who used aminoglycoside antibiotics or neuromuscular junction function drugs within the past 1 week; (14) Any medical condition that may increase the risk when using BTX-A; (15) Those with bleeding tendency; (16) Those who used anticoagulant preparations within 1 week; (17) Others. 3.Enterocystoplasty: (1) Intestinal diseases or dysfunctions: including inflammatory bowel disease (Crohn's disease, radiation enteritis, etc.), short bowel syndrome, intestinal obstruction, severe intestinal adhesion, intestinal ischemia, intestinal tumors, etc.; (2) Urinary tract infection; (3) Coagulopathy; (4) Impairment of important organ functions such as renal failure, liver failure, and heart failure; (5) Severe bladder fibrosis or scarring; (6) Pregnancy or lactation period; (7) Others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine metabolomics;Urinary Microbiota; | — |
Countries
China
Contacts
Public ContactLiao Limin
China Rehabilitation Research Center
Outcome results
None listed