Bladder hyperactivity associated with benign prostatic hyperplasia
Conditions
Interventions
Experimental group:Mirabegron + Tamsulosin Hydrochloride
Control group:Tamsulosin hydrochloride
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Males Aged 18 to 80 years; 2.Clinical diagnosis of BPH (including previous diagnosis of BPH single-use alpha-blocker and new diagnosis of BPH) (diagnostic criteria: IPSS>=8; QoL>=3; prostate volume>=25ml; Qmax: 5~15 ml/ L, total urine output 150ml); 3.OAB diagnosis is established (diagnostic criteria: OABSS score: urgency > 1 time per week; total score > 3 points); 4 For those with PVR>=50ml, urodynamics shows that the bladder safe volume >300ml; 5.Take the test voluntarily and agree to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Other reasons cause bladder outlet obstruction and urethral stricture; 2.Excessive activity of the detrusor muscle caused by neurogenic causes; 3.There is evidence of urinary tract infection (Urine routine shows: WBC(+)); infection control can participate in experiments; Previous recurrent urinary tract infections; 4.Urinary calculi; 5.Chronic inflammation, such as interstitial cystitis and prostatitis; 6.Receive OAB non-drug treatment, and apply muscarinic receptor antagonist within 2 weeks; 7.Have had bladder perfusion therapy in the past 12 months, such as botulinum; 8.Drugs: application of 5a reductase inhibitors; application of vasopressin and desmopressin; application of selective serotonin reuptake inhibitors and psychotropic drugs; 9.Cardiovascular or cerebrovascular diseases with obvious clinical symptoms; 10.The average QTcF interval> 450msec (male) or there is a risk of QT interval prolongation; 11.Clinically obvious abnormal of 12-lead electrocardiogram; 12.Severe hypertension (>180/110mmHg); 13.Moderate to severe liver injury (Child-Pugh grade B or C; AST and/or ALT>2 times the upper limit, or GGT>3 times the upper limit, or total bilirubin>2 times the upper limit.); 14.Severe kidney injury (Glomerular filtration rate 150µmol/L 15.Patients with indwelling catheterization or practicing intermittent self-catheterization; 16.Uncontrollable angle-closure glaucoma, gastric retention, severe ulcerative colitis or Crohn's disease, toxic megacolon, myasthenia gravis or contraindications for anticholinergic therapy; 17.Allergic to Tamsulosin Hydrochloride or Mirabegron; 18.Malignant tumors of the urinary system; 19.After radical prostatectomy, after transurethral resection of the prostate, after urethral dilation; 20.PSA: 4-10 ng/ml, prostate cancer needs to be excluded. ((1) Negative digital rectal examination; (2) Negative transrectal ultrasound of the prostate; (3) Negative prostate biopsy); 21.PVR >300ml; 22.Obvious stress urinary incontinence, or mixed urinary incontinence, and stress urinary incontinence dominates; 23.History of drinking or drug abuse; 24.Participated in other clinical trials within 4 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overactive bladder symptom score;International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mmaximum urinary flow rate;Residual urine; | — |
Countries
China
Contacts
Public ContactLi Yan
Qilu Hospital of Shandong University
Outcome results
None listed