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BOTOX Injection Technique for LUTS Due to BPH

NCT07645456 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia

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.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-04-10
Completion
2026-04-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645456 on ClinicalTrials.gov