Erectile DysfunctionPhase 2/3NCT04172558
Intracavernous Injection of Botox 100 U for Treatment of PDE5Is Inconvenient Patients With ED
A Phase 2/3 study testing OnabotulinumtoxinA and Trimix in people with Erectile Dysfunction, run by Benha University at 1 site in Egypt.
Trial summary
There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- OnabotulinumtoxinA and Trimix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2019to 1 Nov 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A "No" response on Sexual encounter profile questions (SEP 2 \& 3)
Who cannot join
- psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Banha University Hospitals
Banhā, Kalubiaya, 13518
Waleed El-Shaer
About this study
Official title: Intracavernous Injection of Onabotulinumtoxin-A 100 U For Treatment of Phosphodiesterase Type 5 Inhibitors-Inconvenient Patients With Erectile Dysfunction: A Randamized Controlled Trial.
There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.
Read the detailed description
Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A.
Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders.
Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital.
patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix .
Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months after treatment.
- Conditions
- Erectile Dysfunction
- Being tested
- OnabotulinumtoxinA, Trimix
- Keywords
- Botulimium Toxin, Eractile Dysfunction, ICI
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinABiological
Also called Grroup 1
a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test.
TrimixDrug
Also called Group 2
on demand ICI of Trimix
| Study group | Role | What they receive |
|---|---|---|
| BTX100 group | Active comparator | ICI of Botox 100 U Receives: Biological: OnabotulinumtoxinA |
| Trimix group | Active comparator | ICI of Trimix Receives: Drug: Trimix |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF)
Changes in the Erectile Function (EF) domain score of the International Index of change of Erectile Function measured by (IIEF) between treatment periods and baseline in the 2 study arms. It ranges between 0 to 25
Measured: baseline, 2 weeks post treatment then every 3 months post treatment
Dopller study
measurement of Cavernosal artery peak systolic and end diastolic velocities before and after ICI
Measured: baseline, 2 weeks post treatment then every 3 months post treatment
Erection hardness score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Clinical assessment of the Erection hardness score by the investigators in both Erection hardness score
Erection hardness score which is ranged 0 to 4
Measured: baseline, 2 weeks post treatment then every 3 months post treatment
Secondary outcomes (2)
Sexual Encounter Profile 2&3
Assessment of SEP before and after ICI. patient answer ' Yes' or 'No'.
Measured: baseline, 2 weeks post treatment then every 3 months post treatment
Global Assessment Questionnaire
Global Assessment Questionnaire with Yes/No response
Measured: baseline, 2 weeks post treatment then every 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start10 Mar 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
- Investigators
- Waleed El-Shaer, MD, Principal investigator, Banha Univesity hosptals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172558
- Sponsor's protocol ID
- IDIRB2017122601-34
- Status last verified
- Jul 2022
- First submitted
- 19 Nov 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavernous Injection of Onabotulinumtoxin-A 100 U For Treatment of Phosphodiesterase Type 5 Inhibitors-Inconvenient Patients With Erectile Dysfunction: A Randamized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04172558
- Acronym / sponsor ID
- IDIRB2017122601-34
- Conditions
- Erectile Dysfunction
- Keywords
- Botulimium Toxin, Eractile Dysfunction, ICI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.
Detailed description
Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A.
Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders.
Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital.
patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix .
Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTX100 group | Active comparator | Biological: OnabotulinumtoxinAICI of Botox 100 U |
| Trimix group | Active comparator | Drug: TrimixICI of Trimix |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A "No" response on Sexual encounter profile questions (SEP 2 \& 3)
Key exclusion criteria (1 listed)
- psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: Grroup 1a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test. | Biological | BTX100 group |
| TrimixAlso: Group 2on demand ICI of Trimix | Drug | Trimix group |
Primary outcome
International Index of Erectile Function (IIEF)
Time frame: baseline, 2 weeks post treatment then every 3 months post treatment
Changes in the Erectile Function (EF) domain score of the International Index of change of Erectile Function measured by (IIEF) between treatment periods and baseline in the 2 study arms. It ranges between 0 to 25
Dopller study
Time frame: baseline, 2 weeks post treatment then every 3 months post treatment
measurement of Cavernosal artery peak systolic and end diastolic velocities before and after ICI
Erection hardness score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Clinical assessment of the Erection hardness score by the investigators in both Erection hardness score
Time frame: baseline, 2 weeks post treatment then every 3 months post treatment
Erection hardness score which is ranged 0 to 4
2 secondary outcomes
Sexual Encounter Profile 2&3
Time frame: baseline, 2 weeks post treatment then every 3 months post treatment
Global Assessment Questionnaire
Time frame: baseline, 2 weeks post treatment then every 3 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed El-Shaer, MD principal investigator
Banha Univesity hosptals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OnabotulinumtoxinA and Trimix in people with Erectile Dysfunction, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed El-Shaer, MD (01015767331, waleed_elshaer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF) (time frame: baseline, 2 weeks post treatment then every 3 months post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.