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COMPLETED
NCT07645456
PHASE1

BOTOX Injection Technique for LUTS Due to BPH

Sponsor: Benha University

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.

Official title: Is There an Added Benefit of Combined BOTOX Injection in the Bladder Neck, Prostatic Urethra, and Prostatic Parenchyma Versus Injection in Prostatic Parenchyma Alone in BPH Patients With Prostate 30 - 60 gm: A Prospective Randomized Comparative Study?

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-01

Completion Date

2026-04-20

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

Botulinum Toxin Type A (BoNT-A)

A total dose of 200 units of botulinum toxin type A diluted in 20 mL normal saline is injected into multiple sites including the prostatic parenchyma, bladder neck, and prostatic urethra via cystoscopic guidance.

Locations (1)

Benha University Hospitals

Banhā, Qalyubia Governorate, Egypt