BOTOX Injection Technique for LUTS Due to BPH (BOTOX-BPH)

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?

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Botulinum Toxin Type A (BoNT-A)

Detailed Description

This prospective, randomized, comparative study investigated whether combining botulinum toxin type A (Botox) injections in the bladder neck, prostatic urethra, and prostatic parenchyma offers an added clinical benefit compared to injecting the prostatic parenchyma alone. The research was conducted by a team of urologists including Mohamed Aboulfotouh El Gharably, Helmy Ahmed Eldib, Ahmed Ebrahim Zahran, Mahmoud Farag, Hazem Mohamed Ali, and Yahia Elkerdasy. The study focused on patients with benign prostatic hyperplasia (BPH) presenting with a prostate size between 30 and 60 grams. The clinical rationale behind utilizing Botox is its ability to obstruct the release of acetylcholine at neuromuscular junctions, which relaxes the smooth muscle surrounding the bladder neck and prostate stroma while inducing apoptosis in prostatic parenchymal cells to reduce the overall prostate volume.

The methodology involved sixty male participants who experienced persistent moderate lower urinary tract symptoms (LUTS) and a low maximum urinary flow rate (Qmax) despite undergoing six months of medical treatment. To qualify for the trial, patients needed to have an International Prostate Symptom Score (IPSS) greater than 12, a Qmax below 15 mL/second, and a prostate volume of 30 to 60 grams, while individuals with urethral strictures, neurogenic voiding disorders, or high post-void residual volumes over 250 mL were excluded. The sixty patients were evenly randomized into two cohorts of thirty using an opaque sealed envelope technique. Group A received a cystoscopic injection of 200 units of Botox divided across the prostatic parenchyma, bladder neck, and prostatic urethra, whereas Group B received the same dose exclusively within the prostatic parenchyma. Both procedures were performed under intravenous general anesthesia, and patients discontinued their standard LUTS medications following the injections.

Post-operative outcomes were tracked during a six-month follow-up period with key evaluations scheduled at one, three, and six months. The statistical findings demonstrated that Group A achieved a significantly greater reduction in prostate volume compared to Group B from the one-month mark onward, an improvement that stabilized between the third and sixth months. Additionally, Group A demonstrated a significantly lower post-void residual volume (PVRV) and a significantly higher Qmax value than Group B starting at one month and persisting through the entire six-month duration. Symptom severity, measured via IPSS, showed that both groups improved over time, but Group A exhibited significantly lower IPSS scores than Group B from one month onward, with the most substantial enhancements occurring within the first three months.

The study concluded that the combined Botox injection technique delivers superior clinical outcomes compared to injecting the prostatic parenchyma alone, driven by its simultaneous action on both the static glandular tissue and dynamic smooth muscle components of the prostate. The authors highlighted certain limitations of their trial, such as the absence of a third placebo control group to validate the results against a potential placebo effect. They recommended that future multi-center studies feature extended follow-up periods and compare different injection approaches, such as trans-perineal, trans-rectal, and transurethral routes, to reach a definitive consensus on standardized inclusion criteria and injection techniques for treating BPH with botulinum toxin.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt
      • Benha University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Botox Injection; 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); 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.
Active Comparator: Prostatic Parenchyma Injection Only; Participants receive cystoscopic administration of botulinum toxin type A injected only into the prostatic parenchyma under anesthesia.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS); Prostate enlargement
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; incobotulinumtoxinA
• Other Study ID Numbers: Rc.12.10.2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No