Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus ethanol for treatment of benign prostatic hyperplasia (BPH).

Detailed Description
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To compare safely and efficacy of transrectal intraprostatic injection of botulinum toxin A versus ethanol for treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to medical treatment.

Official Title
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Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia Refractory to Medical Treatment

Conditions
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Male, Ultrasonography, Botulinum Toxins, Type A, Injection; Complications, Infection, Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Botulinum toxin A
* Procedure: Ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: international prostate symptoms score (IPSS) > 7 Qmax < 15 Patients with refractory symptomatic BPH to medications patients high risk for surgery or unwilling to do surgery Exclusion Criteria: bladder stones acute or chronic urinary retention urethral stricture bladder or prostatic carcinoma. Neurogenic bladder dysfunctions

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: botulinum toxin A<br>Intraprostatic injection of botulinum toxin A (onabotulinumtoxinA; 100 IU) through transrectal ultrasonography. One vial (100 IU) is dissolved in 10 ml saline and injected in the transition zone of each lobe of the prostate in 3 sites; basal, middle and apical. one gm intramuscular ceftriaxone started and continued 3 days. A rectal enema performed the night before the procedure. The anal area sterilized A 21 gauge needle was introduced to the prostate. | Procedure: Botulinum toxin A<br> <br> * Other names: onabotulinumtoxinA;|
| Active Comparator: Ethanol<br>Intraprostatic injection of dehydrated ethanol through transrectal ultrasonography. An amount equal to 25% of prostate volume was injected distributed over 6-8 sites among both prostatic lobes with an average of 2 ml per site. one gm intramuscular ceftriaxone started and continued 3 days. A rectal enema performed the night before the procedure. The anal area sterilized A 21 gauge needle introduced to the prostate. | Procedure: Ethanol<br> <br> * Other names: dehydrated ethanol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International prostate symptom score (IPSS) | 7 items Questionnaire with a score range from 0 - 35 (5 points for each item) A score of 35 is considered the worst The score is calculated during each period of follow-up The difference in the score in each group will be compared versus each other to detect any significant difference between both groups | 1, 3, 6 months and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum flow rate (Qmax) | The peak flow rate measured during flowmetry (mL/Sec) Increase in the flow rate is considered improvement The Qmax is calculated during each period of follow-up by flowmetry The difference in the Qmax in each group will be compared versus each other to detect any significant difference between both groups | 1, 3, 6 months and one year | 
| Prostate volume | Prostate volume (PV) will be measured by transrectal US (Cubic cm) Decrease in size is considered improvement The PV is calculated during each period of follow-up The difference in the PV in each group will be compared versus each other to detect any significant difference between both groups | 1, 3, 6 months and one year | 
| quality of life (QoL) | one items Questionnaire It is the QoL portion of the International prostate symptom score (IPSS) The score range from 0 - 6 A score of 6 is considered the worst The score is calculated during each period of follow-up The difference in the score in each group will be compared versus each other to detect any significant difference between both groups | 1, 3, 6 months and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower urinary tract symptoms, Botulinum toxin, OnabotulinumtoxinA, Prostate, ethanol ablation of the prostate, Benign prostatic hyperplasia (BPH), Ethanol, Transrectal, BPH, onaBoNT-A, Botox, Quality of life, IPSS, Randomised controlled study