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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03385161
Other study ID # 61352
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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