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

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385161
• Other study ID #: 61352
• Status: Completed
• Phase: N/A
• First received: December 20, 2017
• Last updated: December 27, 2017
• Start date: December 2013
• Est. completion date: June 2017

Study information

• Verified date: December 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Botulinum toxin A

• Ethanol

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Magno C, Mucciardi G, Galì 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 — View 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 — View 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. — View 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	retention of urine	Significant difference between the rate (%) of development of retention of urine in both groups during follow-up	1, 3, 6 months and one year
Other	Other lines of treatment including TURP	Significant difference between the rate (%) of required TURP and other lines of treatment in both groups (due to failure of studied intervention to improve symptoms of the patient )	1, 3, 6 months and one year
Primary	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	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	1, 3, 6 months and one year
Secondary	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	1, 3, 6 months and one year
Secondary	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	1, 3, 6 months and one year