Skip to main content
OpenTrials
Completed

NCT Number: NCT03385161

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Botulinum Toxins, Type A Genital Diseases Genital Diseases, Male Infections Injection; Complications, Infection Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Ultrasonography Urogenital Diseases Urological Manifestations

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 12222, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Procedure

Other names: onaBONT/A, botox, onabotulinumtoxinA

Ethanol

Procedure

Other names: dehydrated ethanol

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. 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

  2. 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 )

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Dec 28, 2017
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.