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

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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