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

NCT03385161 | Completed DMC

• 1 other identifier: 61352
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

  1, 3, 6 months and one year

Secondary Outcomes (3)

• Maximum flow rate (Qmax)

  1, 3, 6 months and one year

• Prostate volume

  1, 3, 6 months and one year

• quality of life (QoL)

  1, 3, 6 months and one year

Other Outcomes (2)

• retention of urine

  1, 3, 6 months and one year

• Other lines of treatment including TURP

  1, 3, 6 months and one year

Study Arms (2)

botulinum toxin A

ACTIVE COMPARATOR

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.

Procedure: Botulinum toxin A

Ethanol

ACTIVE COMPARATOR

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.

Procedure: Ethanol

Interventions

Botulinum toxin A PROCEDURE

Also known as: onaBONT/A, botox, onabotulinumtoxinA

botulinum toxin A

Ethanol PROCEDURE

Also known as: dehydrated ethanol

Ethanol

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Prostate is only in males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, 12222, Egypt

Location

Related Publications (4)

• 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.

  PMID: 28840969 RESULT

• 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.

  PMID: 23098762 RESULT

• 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.

  PMID: 18478352 RESULT

• 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.

  PMID: 19054163 RESULT

MeSH Terms

Conditions

Infections; Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Botulinum Toxins, Type A; onabotulinum toxin A; Ethanol

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Alcohols; Organic Chemicals

Study Officials

• Mohammed S ElSheemy, Ass. Prof.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the surgeon during injection knows the active material
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2017
• Last Updated: December 28, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)