Clinical Trial

BOTOX Injection Technique for LUTS Due to BPH

Study acronym: BOTOX-BPH
Completed Phase 1
View on ClinicalTrials.gov →
Summary
his prospective, randomized comparative study evaluated whether a combined Botulinum Toxin Type A (BOTOX) injection technique provides superior outcomes compared to injecting the prostatic parenchyma alone for patients with benign prostatic hyperplasia (BPH) and a prostate volume of 30-60 grams. Sixty men with persistent, medically refractory lower urinary tract symptoms (LUTS) were divided equally into Group A, who received 200 U of Botox combined across the prostatic parenchyma, bladder neck, and prostatic urethra, and Group B, who received injections solely into the prostatic parenchyma. Over a 6-month follow-up period, both groups showed improvement, but Group A (the combined injection group) demonstrated significantly greater clinical success. Specifically, the combined injection approach resulted in a significantly larger reduction in prostate volume (PV) and post-void residual volume (PVRV), alongside significantly higher maximum urinary flow rates and lower International Prostate Symptom Scores (IPSS) starting from the first month and persisting through the study's end. The authors concluded that the combined injection technique yields superior outcomes because it effectively targets both the static (anatomical enlargement) and dynamic (smooth muscle tone) components of BPH-induced bladder outlet obstruction.
Trial Details
NCT Number NCT07645456
Lead Sponsor Benha University
Conditions Benign Prostatic Hyperplasia
Enrollment 60 participants
Start Date 2025-10-01
Primary Completion 2026-04-10 (estimated)
Study Completion 2026-04-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-12