Benign prostatic hyperplasia. Benign neoplasm of prostate
Conditions
Interventions
Intervention 1: Intervention group: Patients in this group will be injected with Botox in the bladder neck area.The way to inject Botox is that every 100 international units of Bo-A will be diluted in
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1- Prostate volume more than 30 ml 2- Obtaining a score higher than 8 from the International Prostate Symptom Score (IPSS) 3- Serum level total prostate specific antigen (tPSA) less than 10ng/mL 4- maximum urinary flow rate (Qmax) less than 16 ml/s 5- Voided volume (VV) more than 150 ml
Exclusion criteria
Exclusion criteria: 1- Having an active and recurrent urinary tract infection 2- History of previous prostatectomy 3- History of prostate cancer 4- Bladder or prostate stones 5- History of using phenylephrine, pseudoephedrine, imipramine, cholinergic, anticholinergic, estrogen, androgen and steroid since 4 weeks before the intervention 6- Biopsy from 6 weeks before the intervention 7- History of unstable angina pectoris, primary neurological disease that affects bladder function, such as multiple sclerosis, myasthenia gravis, Parkinson's 8- History of BoNT-A intraprostatic administration 9- Taking ASA, warfarin and NSAIDs from 6 days before the intervention 10- History of bladder sensitivity to BoNT-A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum urinary flow rate. Timepoint: Before and 3 months after the intervention. Method of measurement: Uroflowmetry test.;Total Prostate Specific Antigen. Timepoint: Before and 3 months after the intervention. Method of measurement: ELISA test on blood sample.;Prostate volume. Timepoint: Before and 3 months after the intervention. Method of measurement: Examination of ultrasound results.;Prostate symptoms. Timepoint: Before and 3 months after the intervention. Method of measurement: International Prostate Symptom Score. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDinyar Khazaeli
Ahvaz University of Medical Sciences
Outcome results
None listed