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

Not Applicable

Completed

• Conditions: Ultrasonography; Male; Botulinum Toxins, Type A; Injection; Complications, Infection; Prostatic Hyperplasia
• Interventions: Procedure: Ethanol; Procedure: Botulinum toxin A

• Registration Number: NCT03385161
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-06
• Study Completion: 2017-06
• Status Verified: 2017-12
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-27
• Last Update Submitted: 2017-12-27
• Study First Posted: 2017-12-28
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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

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Exclusion Criteria

• bladder stones
• acute or chronic urinary retention
• urethral stricture
• bladder or prostatic carcinoma.
• Neurogenic bladder dysfunctions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ethanol	Ethanol	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.
botulinum toxin A	Botulinum toxin A	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.

Primary Outcome Measures

Name	Time	Method
International prostate symptom score (IPSS)	1, 3, 6 months and one year	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

Secondary Outcome Measures

Name	Time	Method
Maximum flow rate (Qmax)	1, 3, 6 months and one year	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
Prostate volume	1, 3, 6 months and one year	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
quality of life (QoL)	1, 3, 6 months and one year	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

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt