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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
- Significant cardiovascular disease interfering with sexual activity
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| Name | Affiliation | Role |
|---|---|---|
| Islam M Fathy, MD | Cairo University | Study Director |
| Abdelrahman A Hassan, Msc | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Andrology, Cairo University | Cairo | 11231 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
| Label | URL |
|---|---|
| Botulinum Toxin Type A and Erectile Dysfunction (Phase 1 study) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BTX-A Group | Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment. Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment. |
| FG001 | Placebo Group | Saline Group: The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment. Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One patient was dropped out from the treatment group 6 weeks after of BTX injection.
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| ID | Title | Description |
|---|---|---|
| BG000 | BTX-A Group | Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment. Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | cm/sec | Baseline |
|
Adverse effects were collected at 2, 6 and12 weeks for each patient throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTX-A Group | Experimental: BTX-A Group The treatment group, 80 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment. Botulinum Toxin Type A: Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hussein Ghanem, Directer of this clinical trial | Cairo University | 01001176111 | hmhghanem@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2017 | Oct 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Prospective, randomized double blind placebo control ( RDBPC) study.
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| Normal saline | Drug | The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment. |
|
| 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. | 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. | 6 and 12 weeks after injection. |
| Penile Size Before Treatment | Measurement of penile length before treatment: Flaccid, stretched and erect penile length. | Baseline |
| Penile Size After Treatment | Measurement of penile length after treatment. | 2 weeks after injection. |
| Penile Size After Treatment | Measurement of penile length after treatment. | 6 and 12 weeks after injection. |
| Intra-vaginal Latency Time Before Treatment | Measurement of the duration of intercourse from intromission to ejaculation before treatment. | Baseline |
| Intra-vaginal Latency Time After Treatment | Measurement of the duration of intercourse from intromission to ejaculation after treatment. | 2 weeks after injection. |
| Intra-vaginal Latency Time After Treatment | Measurement of the duration of intercourse from intromission to ejaculation after treatment. | 6 and 12 weeks after injection. |
| Placebo Group |
Saline Group: The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment. Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | cm/sec | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after injection. |
|
|
|
| Secondary | 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. | One patient was dropped out after 2 weeks of injection from the BTX-A Group | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 weeks after injection. |
|
|
|
| Secondary | Penile Size Before Treatment | Measurement of penile length before treatment: Flaccid, stretched and erect penile length. | Posted | Mean | Standard Deviation | cm | Baseline |
|
|
|
| Secondary | Penile Size After Treatment | Measurement of penile length after treatment. | Posted | Mean | Standard Deviation | cm | 2 weeks after injection. |
|
|
|
| Secondary | Penile Size After Treatment | Measurement of penile length after treatment. | One patient was dropped out from the treatment group after 2 weeks injection. | Posted | Mean | Standard Deviation | cm | 6 and 12 weeks after injection. |
|
|
|
| Secondary | Intra-vaginal Latency Time Before Treatment | Measurement of the duration of intercourse from intromission to ejaculation before treatment. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Intra-vaginal Latency Time After Treatment | Measurement of the duration of intercourse from intromission to ejaculation after treatment. | Posted | Count of Participants | Participants | 2 weeks after injection. |
|
|
|
| Secondary | Intra-vaginal Latency Time After Treatment | Measurement of the duration of intercourse from intromission to ejaculation after treatment. | One patient was dropped out from the treatment group after 2 weeks injection. | Posted | Count of Participants | Participants | 6 and 12 weeks after injection. |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo Group | Saline Group: The control group, 80 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment. Normal saline: The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Erect penile length |
|
| After 2 weeks erect |
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| After 12 weeks flaccid |
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| After 12 weeks stretched |
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| IVLT more than 3 minutes |
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| After 2 weeks IVLT more than 3 minutes |
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| After 6 weeks IVLT more than 3 minutes |
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| After 12 weeks IVLT less than 1 minute |
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| After 12 weeks IVLT between 1 to 3 minutes |
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| After 12 weeks IVLT more than 3 minutes |
|