Erectile DysfunctionPhase 2NCT03355963
Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction
A Phase 2 study testing saline injection, Botulinum toxin type A 50 units and Botulinum toxin type A 100 units in people with Erectile Dysfunction and Botulinum Toxin, run by Benha University.
Trial summary
purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction, Botulinum Toxin
- What is being tested?
- saline injection, Botulinum toxin type A 50 units and Botulinum toxin type A 100 units
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2016to 20 Feb 2019
- Phase
- Phase 2
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 \& 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
Who cannot join
- Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
About this study
Official title: Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction
purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.
Patients and Methods: This study will be conducted on 200 patients diagnosed as vascular erectile dysfunction by penile color Doppler not responding to medical and injection therapy presenting to Urology department and outpatient clinic at Benha University Hospital, Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University.(multicentric study).
Read more
A- Inclusion criteria:
- Age between 40 to 70 years.
- Vascular ED proved by penile duplex.
- Unable to develop erections sufficient for intercourse.
- A "No" response on Sexual encounter profile questions (SEP 2 \& 3)
- Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
B-Exclusion criteria:
- Significant cardiovascular disease interfering with sexual activity
- Any history of an unstable medical or psychiatric condition
- Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function. patients will be simply randomized into 3 equal groups, one control group and two treatment groups. Ethics committee approval and informed consent were obtained.
Read the detailed description
introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous (IC) therapy, thus avoiding surgical treatment options.
patient and methods: All patients will perform penile color Doppler evaluation to confirm a vascular etiology, a trimix solution (PGE1 10 ug + Phentolamine 1 mg + Papaverine 30 mg) was injected IC during the penile Doppler study.
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Assessment for all groups was done by penile color Doppler exam, Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) were completed pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment.
Procedure:
At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 50 units of BTX-A for patients in treatment group B and 100 units of BTX-A for patients in treatment group C with direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.
Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the ,Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) before and 2 weeks, 3 months and 6 months after treatment .
The rational for selecting the minimum 2-weeks waiting period is to give a chance for the BTX-A to reach its maximum effect. Possible Risks include pain and prolonged erections, also 3 months and 6 months after treatment do detect safety, efficacy and durability.
- Conditions
- Erectile Dysfunction, Botulinum Toxin
- Being tested
- saline injection, Botulinum toxin type A 50 units, Botulinum toxin type A 100 units
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline injectionOther
Also called group A (control group)
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Botulinum toxin type A 50 unitsBiological
Also called group B
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Botulinum toxin type A 100 unitsBiological
Also called group C
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test. Receives: Other: saline injection |
| Group B | Active comparator | The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test. Receives: Biological: Botulinum toxin type A 50 units |
| Group C | Active comparator | The treatment group C:
intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test. Receives: Biological: Botulinum toxin type A 100 units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow:
> 7 severe dysfunction 7-12 Moderate dysfunction
13-18 Mild to moderate dysfunction
19-24 Mild dysfunction
25-30 No dysfunction
Measured: pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment
the Sexual Event Profile (SEP) scores
Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .
Measured: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Global Assessment Questionnaire (GAQ) scores
Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response
Measured: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Cavernosal artery peak systolic and end diastolic velocities
Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Measured: baseline, 2 weeks post treatment , 3, and 6 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 posted29 Nov 2017
- Study start12 Jul 2016
- Primary completion25 Jan 2019
- Study completion20 Feb 2019
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355963
- Sponsor's protocol ID
- 19-09-2016
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2017
- Last updated
- 26 Nov 2019
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03355963
- Acronym / sponsor ID
- 19-09-2016
- Conditions
- Erectile Dysfunction, Botulinum Toxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 29 Nov 2017 (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.
purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.
Patients and Methods: This study will be conducted on 200 patients diagnosed as vascular erectile dysfunction by penile color Doppler not responding to medical and injection therapy presenting to Urology department and outpatient clinic at Benha University Hospital, Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University.(multicentric study).
A- Inclusion criteria:
- Age between 40 to 70 years.
- Vascular ED proved by penile duplex.
- Unable to develop erections sufficient for intercourse.
- A "No" response on Sexual encounter profile questions (SEP 2 \& 3)
- Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
B-Exclusion criteria:
- Significant cardiovascular disease interfering with sexual activity
- Any history of an unstable medical or psychiatric condition
- Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function. patients will be simply randomized into 3 equal groups, one control group and two treatment groups. Ethics committee approval and informed consent were obtained.
Detailed description
introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous (IC) therapy, thus avoiding surgical treatment options.
patient and methods: All patients will perform penile color Doppler evaluation to confirm a vascular etiology, a trimix solution (PGE1 10 ug + Phentolamine 1 mg + Papaverine 30 mg) was injected IC during the penile Doppler study.
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Assessment for all groups was done by penile color Doppler exam, Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) were completed pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment.
Procedure:
At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 50 units of BTX-A for patients in treatment group B and 100 units of BTX-A for patients in treatment group C with direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.
Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the ,Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) before and 2 weeks, 3 months and 6 months after treatment .
The rational for selecting the minimum 2-weeks waiting period is to give a chance for the BTX-A to reach its maximum effect. Possible Risks include pain and prolonged erections, also 3 months and 6 months after treatment do detect safety, efficacy and durability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: saline injectionThe control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test. |
| Group B | Active comparator | Biological: Botulinum toxin type A 50 unitsThe treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test. |
| Group C | Active comparator | Biological: Botulinum toxin type A 100 unitsThe treatment group C: intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 \& 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
Key exclusion criteria (1 listed)
- Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or 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 |
|---|---|---|
| saline injectionAlso: group A (control group)The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test. | Other | Group A |
| Botulinum toxin type A 50 unitsAlso: group BThe treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test. | Biological | Group B |
| Botulinum toxin type A 100 unitsAlso: group CThe treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test. | Biological | Group C |
Primary outcome
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
Time frame: pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment
Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow: > 7 severe dysfunction 7-12 Moderate dysfunction 13-18 Mild to moderate dysfunction 19-24 Mild dysfunction 25-30 No dysfunction
the Sexual Event Profile (SEP) scores
Time frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .
Global Assessment Questionnaire (GAQ) scores
Time frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response
Cavernosal artery peak systolic and end diastolic velocities
Time frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saline injection, Botulinum toxin type A 50 units and Botulinum toxin type A 100 units in people with Erectile Dysfunction and Botulinum Toxin, run by Benha University.
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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) (time frame: pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment). The study lists 4 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 26 Nov 2019.