NCT03102762

Brief Summary

To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral PDE5i - through cavernosal smooth muscle relaxation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 5, 2019

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

March 28, 2017

Results QC Date

March 17, 2019

Last Update Submit

December 23, 2019

Conditions

Sexual DysfunctionErectile Dysfunction

Keywords

Erectile dysfunctionBotulinum toxin ABotox

Outcome Measures

Primary Outcomes (2)

  • Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment

    Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.

    Baseline

  • Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment

    Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.

    2 weeks

Secondary Outcomes (9)

  • SHIM Score Before Treatment

    Baseline

  • SHIM Score After Treatment

    2 weeks after injection.

  • SHIM Score After Treatment

    6 and 12 weeks after injection.

  • Penile Size Before Treatment

    Baseline

  • Penile Size After Treatment

    2 weeks after injection.

  • +4 more secondary outcomes

Study Arms (2)

Botulinum Toxin Type A (BTX-A) Group

EXPERIMENTAL

Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.

Drug: Botulinum Toxin Type A

Placebo Group

PLACEBO COMPARATOR

Saline Group: The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.

Drug: Normal saline

Interventions

Botulinum Toxin Type ADRUG

Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.

Botulinum Toxin Type A (BTX-A) Group
Normal salineDRUG

The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.

Placebo Group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males will be included in the study recruited from Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of ED.
  • Unable to develop erections sufficient for intercourse.
  • Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
  • Age between 18 to 80 years.

You may not qualify if:

  • \- Significant cardiovascular disease interfering with sexual activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Andrology, Cairo University

Cairo, 11231, Egypt

Location

Related Publications (1)

  • Ghanem H, Soliman I, AbdulHamid M, et. PS-08-016 Can intracavernosal botulinum toxin injection salvage vascular erectile dysfunction patients not responding to oral and intracavernous therapy? A pilot study. May 2016. Volume 13, Issue 5, Supplement 2, Page S116.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalErectile Dysfunction

Interventions

Botulinum Toxins, Type ASaline Solution

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Hussein Ghanem, Directer of this clinical trial
Organization
Cairo University
hmhghanem@gmail.com
01001176111

Study Officials

  • Islam M Fathy, MD

    Cairo University

    STUDY DIRECTOR

  • Abdelrahman A Hassan, Msc

    Cairo University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized double blind placebo control ( RDBPC) study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 6, 2017

Study Start

January 3, 2017

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

January 7, 2020

Results First Posted

December 5, 2019

Record last verified: 2019-12

Locations

EG(1)