BOTOX Injection Technique for LUTS Due to BPH

NCT07645456 | Completed Phase 1 DMC

• 1 other identifier: Rc.12.10.2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS); Prostate enlargement

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (IPSS) will be used to assess the severity of lower urinary tract symptoms (LUTS). The outcome measure is defined as the change in IPSS from baseline following treatment with botulinum toxin type A injections.

  Baseline to 6 months post-intervention

Study Arms (2)

Combined Botox Injection

EXPERIMENTAL

Participants receive cystoscopic administration of botulinum toxin type A injected into the prostatic parenchyma, bladder neck, and prostatic urethra under anesthesia

Drug: Botulinum Toxin Type A (BoNT-A)

Prostatic Parenchyma Injection Only

ACTIVE COMPARATOR

Participants receive cystoscopic administration of botulinum toxin type A injected only into the prostatic parenchyma under anesthesia.

Drug: Botulinum Toxin Type A (BoNT-A)

Interventions

Botulinum Toxin Type A (BoNT-A) DRUG

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.

Combined Botox Injection; Prostatic Parenchyma Injection Only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: They should be biologically male to have a prostate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) Moderate symptoms, defined as International Prostate Symptom Score (IPSS) \> 12 Maximum urinary flow rate (Qmax) \< 15 mL/second Prostate volume between 30 and 60 grams Persistent symptoms after at least 6 months of medical therapy for BPH Ability to provide informed consent

You may not qualify if:

• story of chronic bladder catheterization Compromised cardiopulmonary status Contraindications to botulinum toxin type A (BoNT-A) Current urinary tract infection Neurogenic voiding dysfunction Post-void residual (PVR) \> 250 mL History of previous prostatic surgery Prostatitis Urethral strictur

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Qalyubia Governorate, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: October 1, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 20, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

EG (1)