Comparison of bladder botox and tamsulosin tablets in the treatment of symptomatic benign prostatic hyperplasia (BPH) patients.

Not Applicable

Recruiting

Conditions: Benign prostatic hyperplasia.
Benign neoplasm of prostate
D29.1

Registration Number: IRCT20240409061460N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 40

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures