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To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus ethanol for treatment of benign prostatic hyperplasia (BPH).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 lines of treatment including TURP |
Inclusion Criteria:
Exclusion Criteria:
Prostate is only in males
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed S ElSheemy, Ass. Prof. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | 12222 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28840969 | Result | 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. | |
| 23098762 |
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Only the surgeon during injection knows the active material
| Ethanol |
| Procedure |
|
|
| 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 |
| 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 |
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 |
| 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. |
| 18478352 | 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. |
| 19054163 | 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. |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C000629279 | onabotulinum toxin A |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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