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:
intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.

Erectile Dysfunction

Botulinum Toxin

saline injection

Botulinum toxin type A 50 units

The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.

Botulinum toxin type A 100 units

Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction

Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction

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

Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .

Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response

Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.

Waleed El-Shaer, MD

Principal Investigator

Benha University

Cairo University

The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.

The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.

The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.

(BTX) A Group

The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.

Saline Group

Total

Gender

Region of Enrollment

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

(BTX) A

Cavernosal Artery Mean PSV Before Treatment

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

Cavernosal Artery Mean PSV After Treatment

Clinical assessment of the Erection hardness score (EHS) in both groups after ICI at baseline.
The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).
0 - Penis does not enlarge.
- Penis is larger, but not hard.
- Penis is hard, but not hard enough for penetration.
- Penis is hard enough for penetration, but not completely hard.
- Penis is completely hard and fully rigid. The average score is reported for each group.

EHS Before Treatment

Clinical assessment of the Erection hardness score (EHS) in both groups after ICI after 2 weeks.
The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).
0 - Penis does not enlarge.
- Penis is larger, but not hard.
- Penis is hard, but not hard enough for penetration.
- Penis is hard enough for penetration, but not completely hard.
- Penis is completely hard and fully rigid. The average score is reported for each group.

EHS After 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.

SHIM Score Before Treatment

SHIM Score After Treatment

Assessment of the effect of treatment by asking "Has the treatment you have been taking improved your erectile function?". The number answering "Yes" in both the treatment and control groups are calculated.

Global Assessment Question (GAQ)

Number of patients answering "Yes" to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?)

SEP-Q2 Question Before Treatment

Number of patients answering "Yes" to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?) after treatment.
This analysis compares the number of patients who were able to perform vaginal intromission (insert the penis into the partner's vagina) after treatment in the (BTX) A group versus the Saline group.

SEP-Q2 Question After Treatment

Number of patients answering "Yes" to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) before treatment.

SEP-Q3 Question Before Treatment

Number of patients answering "Yes" to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) after treatment.
This analysis compares the number of patients who were able to maintain their erection long enough to complete sexual intercourse after treatment in the (BTX) A group versus the Saline group.

SEP-Q3 Question After Treatment

The treatment group, 12 patients will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.

Study Group

Control Group

Overall Study

Prof. Dr. Hussein Ghanem, Chairman of Andrology Department

Vasculogenic Erectile Dysfunction

The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.

Botulinum Toxin Type A

The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.

Normal Saline

Cairo University Hospitals

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction Not Responding to Oral and Intracavernous Therapy

papaverine/obesity

Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction

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