Studying the Dose Response of 50 and 100 IU of Botox A Toxin Injection in the Prostates of BPH Patients.

Patients and method:

Men with symptomatic BPH will be invited to participate in this prospective study. Inclusion criteria will be an age of above 50 years, persistent moderate to severe LUTS as determined by International Prostatic Symptom Score (IPSS) >8, peak urinary flow rate of less than 12 mL/s, and an enlarged prostate gland on digital rectal examination. Exclusion criteria will be history of previous surgery for BPH, presence of urethral stenosis, urinary tract infection, prostate or bladder cancer, history of pelvic surgery or radiotherapy, neurological diseases, urinary retention and BPH-associated complications requiring surgical treatment including bladder stone, and bilateral hydronephrosis.

Subjects will undergo further evaluation before treatment, including urine analysis, serum creatinine, prostate-specific antigen (PSA), Trans rectal prostatic and Trans abdominal urinary tract sonography, uroflowmetry, and measurement of post-void residual volume (PVR) via abdominal ultrasonography.

Just before the injection procedure, patients will be randomized to receive either 50 U or 100 U of BoNT-A.

• Intervention All patients submitted for intervention will receive oral antibiotics (oral levofloxacin and flagyl 500 mg) 2 days before injection. Patients will be instructed to avoid taking anticoagulants, such as aspirin, for at least seven days prior to the procedure. An enema will be done two to four hours before the ultrasound to clean out the bowel.