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

Cairo University90 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

Botulinum toxin APROCEDURE

EthanolPROCEDURE

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cairo University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 1, 3, 6 months and one year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 1, 3, 6 months and one year

Data from ClinicalTrials.gov

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