Back to resultsIntraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia
Primary Purpose
Male, Ultrasonography, Botulinum Toxins, Type A
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Botulinum toxin A
Ethanol
Sponsored by
About this trial
This is an interventional treatment trial for Male focused on measuring 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
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
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
botulinum toxin A
Ethanol
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03385161
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Only the surgeon during injection knows the active material
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin A
Arm Type
Active Comparator
Arm 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.
Arm Title
Ethanol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Botulinum toxin A
Other Intervention Name(s)
onaBONT/A, botox, onabotulinumtoxinA
Intervention Type
Procedure
Intervention Name(s)
Ethanol
Other Intervention Name(s)
dehydrated ethanol
Primary Outcome Measure Information:
Title
International prostate symptom score (IPSS)
Description
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 Outcome Measure Information:
Title
Maximum flow rate (Qmax)
Description
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
Title
Prostate volume
Description
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
Title
quality of life (QoL)
Description
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
Other Pre-specified Outcome Measures:
Title
retention of urine
Description
Significant difference between the rate (%) of development of retention of urine in both groups during follow-up
Time Frame
1, 3, 6 months and one year
Title
Other lines of treatment including TURP
Description
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 )
Time Frame
1, 3, 6 months and one year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate is only in males
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S ElSheemy, Ass. Prof.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
12222
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28840969
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.
Results Reference
result
PubMed Identifier
23098762
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.
Results Reference
result
PubMed Identifier
18478352
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.
Results Reference
result
PubMed Identifier
19054163
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.
Results Reference
result
Learn more about this trial
Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia
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