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

Cairo University (CU)

Status: Completed

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

Treatments: Procedure: Botulinum toxin A; Procedure: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03385161

61352

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

botulinum toxin A

Active Comparator group

Description:

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.

Treatment:

Procedure: Botulinum toxin A

Ethanol

Active Comparator group

Description:

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.

Treatment:

Procedure: Ethanol