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

December 27, 2017 updated by: Mohammed Said ElSheemy, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12222
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: botulinum toxin A

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
Other Names:
  • botox
  • onabotulinumtoxinA
  • onaBONT/A
ACTIVE_COMPARATOR: Ethanol

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
Other Names:
  • dehydrated ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International prostate symptom score (IPSS)
Time Frame: 1, 3, 6 months and one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum flow rate (Qmax)
Time Frame: 1, 3, 6 months and one year
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
Prostate volume
Time Frame: 1, 3, 6 months and one year
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)
Time Frame: 1, 3, 6 months and one year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention of urine
Time Frame: 1, 3, 6 months and one year
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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohammed S ElSheemy, Ass. Prof., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 27, 2017

First Posted (ACTUAL)

December 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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