Clinical trial NCT03385161: Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia
Official title: Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia Refractory to Medical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male
Ultrasonography
Botulinum Toxins, Type A
Injection; Complications, Infection
Prostatic Hyperplasia
Keywords: ethanol ablation of the prostate
Benign prostatic hyperplasia (BPH)
Prostate
Ethanol
Transrectal
BPH
onaBoNT-A
Botox
Lower urinary tract symptoms
Botulinum toxin
OnabotulinumtoxinA
Quality of life
IPSS
Randomised controlled study
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 90
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: International prostate symptom score (IPSS)
timeFrame: 1, 3, 6 months and one year
Secondary outcomes:
measure: Maximum flow rate (Qmax)
timeFrame: 1, 3, 6 months and one year
measure: Prostate volume
timeFrame: 1, 3, 6 months and one year
measure: quality of life (QoL)
timeFrame: 1, 3, 6 months and one year
Other outcomes:
measure: retention of urine
timeFrame: 1, 3, 6 months and one year
measure: Other lines of treatment including TURP
timeFrame: 1, 3, 6 months and one year
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: Mohammed S ElSheemy, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Totaro A, Pinto F, Pugliese D, Vittori M, Racioppi M, Foschi N, Bassi PF, Sacco E. Intraprostatic botulinum toxin type "A" injection in patients with benign prostatic hyperplasia and unsatisfactory response to medical therapy: A randomized, double-blind, controlled trial using urodynamic evaluation. Neurourol Urodyn. 2018 Mar;37(3):1031-1038. doi: 10.1002/nau.23390. Epub 2017 Aug 25.
citation: Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.
citation: Magno C, Mucciardi G, Gali A, Anastasi G, Inferrera A, Morgia G. Transurethral ethanol ablation of the prostate (TEAP): an effective minimally invasive treatment alternative to traditional surgery for symptomatic benign prostatic hyperplasia (BPH) in high-risk comorbidity patients. Int Urol Nephrol. 2008;40(4):941-6. doi: 10.1007/s11255-008-9394-z. Epub 2008 May 14.
citation: Sakr M, Eid A, Shoukry M, Fayed A. Transurethral ethanol injection therapy of benign prostatic hyperplasia: four-year follow-up. Int J Urol. 2009 Feb;16(2):196-201. doi: 10.1111/j.1442-2042.2008.02205.x. Epub 2008 Nov 27.