Sexual DysfunctionPhase 2/3NCT03102762
Botulinum Toxin for Erectile Dysfunction
A Phase 2/3 study testing Botulinum Toxin Type A and Normal saline in people with Sexual Dysfunction and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Sexual Dysfunction, Erectile Dysfunction
- What is being tested?
- Botulinum Toxin Type A and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2017to 10 Jan 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 70 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.
Who cannot join
- Significant cardiovascular disease interfering with sexual activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)
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.
Read the detailed description
The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.
The investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. The participants will be subjected for full history taking, general and genital examination. Penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. The patients will be randomized into a treatment group (35 patients) and a control group (35 patients).
All patients will sign an informed consent. The treatment group will be injected IC with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler assessment, followed, next day by 50 units of BTX-A. The control group will be injected with the trimix solution during penile color Doppler assessment followed next day with a normal saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.
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 100 units of BTX-A. 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 the Sexual Encounter Profile questions 1 and 2 (SEP 2 \& SEP 3), and the global assessment question (GAQ) before and 4 weeks after treatment.
- Conditions
- Sexual Dysfunction, Erectile Dysfunction
- Being tested
- Botulinum Toxin Type A, Normal saline
- Keywords
- Erectile dysfunction, Botulinum toxin A, Botox
- Medical subject headings
- Sexual Dysfunction, Physiological, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Normal salineDrug
The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (9)
SHIM Score Before Treatment
Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.
Measured: Baseline
SHIM Score After Treatment
Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after treatment for both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.
Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome.
Measured: 2 weeks after injection.
SHIM Score After Treatment
Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after 6 and 12 weeks of both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.
Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome.
Measured: 6 and 12 weeks after injection.
Penile Size Before Treatment
Measurement of penile length before treatment:
Flaccid, stretched and erect penile length.
Measured: Baseline
Penile Size After Treatment
Measurement of penile length after treatment.
Measured: 2 weeks after injection.
Penile Size After Treatment
Measurement of penile length after treatment.
Measured: 6 and 12 weeks after injection.
Intra-vaginal Latency Time Before Treatment
Measurement of the duration of intercourse from intromission to ejaculation before treatment.
Measured: Baseline
Intra-vaginal Latency Time After Treatment
Measurement of the duration of intercourse from intromission to ejaculation after treatment.
Measured: 2 weeks after injection.
Intra-vaginal Latency Time After Treatment
Measurement of the duration of intercourse from intromission to ejaculation after treatment.
Measured: 6 and 12 weeks after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start3 Jan 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Prospective, randomized double blind placebo control ( RDBPC) study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Ghanem, Cairo University
- Investigators
- Islam M Fathy, MD, Study director, Cairo UniversityAbdelrahman A Hassan, Msc, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102762
- Sponsor's protocol ID
- 1232017
- Status last verified
- Dec 2019
- First submitted
- 28 Mar 2017
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)
- ClinicalTrials.gov ID
- NCT03102762
- Acronym / sponsor ID
- 1232017
- Conditions
- Sexual Dysfunction, Erectile Dysfunction
- Keywords
- Erectile dysfunction, Botulinum toxin A, Botox
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 5 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.
The investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. The participants will be subjected for full history taking, general and genital examination. Penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. The patients will be randomized into a treatment group (35 patients) and a control group (35 patients).
All patients will sign an informed consent. The treatment group will be injected IC with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler assessment, followed, next day by 50 units of BTX-A. The control group will be injected with the trimix solution during penile color Doppler assessment followed next day with a normal saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.
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 100 units of BTX-A. 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 the Sexual Encounter Profile questions 1 and 2 (SEP 2 \& SEP 3), and the global assessment question (GAQ) before and 4 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prospective, randomized double blind placebo control ( RDBPC) study.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A (BTX-A) Group | Experimental | Drug: Botulinum Toxin Type AExperimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment. |
| Placebo Group | Placebo comparator | Drug: Normal salineSaline Group: The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 70 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.
Key exclusion criteria (1 listed)
- Significant cardiovascular disease interfering with sexual activity
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 |
|---|---|---|
| Botulinum Toxin Type ADrug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment. | Drug | Botulinum Toxin Type A (BTX-A) Group |
| Normal salineThe treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment. | Drug | Placebo Group |
Primary outcome
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment
Time frame: Baseline
Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment
Time frame: 2 weeks
Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.
9 secondary outcomes
SHIM Score Before Treatment
Time frame: Baseline
SHIM Score After Treatment
Time frame: 2 weeks after injection.
SHIM Score After Treatment
Time frame: 6 and 12 weeks after injection.
Penile Size Before Treatment
Time frame: Baseline
Penile Size After Treatment
Time frame: 2 weeks after injection.
Penile Size After Treatment
Time frame: 6 and 12 weeks after injection.
Intra-vaginal Latency Time Before Treatment
Time frame: Baseline
Intra-vaginal Latency Time After Treatment
Time frame: 2 weeks after injection.
Intra-vaginal Latency Time After Treatment
Time frame: 6 and 12 weeks after injection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundGhanem 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.
- Botulinum Toxin Type A and Erectile Dysfunction (Phase 1 study)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Islam M Fathy, MD study director
Cairo University
Abdelrahman A Hassan, Msc study director
Cairo University
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 Botulinum Toxin Type A and Normal saline in people with Sexual Dysfunction and Erectile Dysfunction, run by Cairo 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 4 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 7 Jan 2020. 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. 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 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?
Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102762, which also lists 1 linked publication.
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 7 Jan 2020.