Trial Outcomes & Findings for Botulinum Toxin for Erectile Dysfunction (NCT NCT03102762)
NCT ID: NCT03102762
Last Updated: 2020-01-07
Results Overview
Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
Baseline
Results posted on
2020-01-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Botulinum Toxin for Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
54.26 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
55.13 years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Egyptian
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineBaseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment
PSV R
|
34.52 cm/sec
Standard Deviation 12.15
|
30.85 cm/sec
Standard Deviation 15.26
|
|
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment
PSV L
|
34.33 cm/sec
Standard Deviation 11.21
|
31.73 cm/sec
Standard Deviation 15.97
|
PRIMARY outcome
Timeframe: 2 weeksCavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment
PSV R
|
45.68 cm/sec
Standard Deviation 13.27
|
31.67 cm/sec
Standard Deviation 15.67
|
|
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment
PSV L
|
46.015 cm/sec
Standard Deviation 13.03
|
32.09 cm/sec
Standard Deviation 16.47
|
SECONDARY outcome
Timeframe: BaselineAssessment 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.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
SHIM Score Before Treatment
|
5.4 score on a scale
Standard Deviation 1.67
|
5.69 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 2 weeks after injection.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.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
SHIM Score After Treatment
|
6.66 score on a scale
Standard Deviation 2.17
|
6.11 score on a scale
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 6 and 12 weeks after injection.Population: One patient was dropped out after 2 weeks of injection from the BTX-A Group
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.
Outcome measures
| Measure |
BTX-A Group
n=34 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
SHIM Score After Treatment
6 weeks after injection
|
9.97 score on a scale
Standard Deviation 5.92
|
5.77 score on a scale
Standard Deviation 1.82
|
|
SHIM Score After Treatment
12 weeks after injection
|
8.26 score on a scale
Standard Deviation 4.07
|
5.57 score on a scale
Standard Deviation 1.399
|
SECONDARY outcome
Timeframe: BaselineMeasurement of penile length before treatment: Flaccid, stretched and erect penile length.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Penile Size Before Treatment
Flaccid penile length
|
10.17 cm
Standard Deviation 1.73
|
10.99 cm
Standard Deviation 2.49
|
|
Penile Size Before Treatment
Stretched penile length
|
13.36 cm
Standard Deviation 1.8
|
13.4 cm
Standard Deviation 2.58
|
|
Penile Size Before Treatment
Erect penile length
|
14.17 cm
Standard Deviation 1.72
|
14.01 cm
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: 2 weeks after injection.Measurement of penile length after treatment.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Penile Size After Treatment
After 2 weeks flaccid
|
10.46 cm
Standard Deviation 1.8
|
11.01 cm
Standard Deviation 2.52
|
|
Penile Size After Treatment
After 2 weeks stretched
|
13.41 cm
Standard Deviation 1.78
|
13.4 cm
Standard Deviation 2.58
|
|
Penile Size After Treatment
After 2 weeks erect
|
14.26 cm
Standard Deviation 1.66
|
14.03 cm
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: 6 and 12 weeks after injection.Population: One patient was dropped out from the treatment group after 2 weeks injection.
Measurement of penile length after treatment.
Outcome measures
| Measure |
BTX-A Group
n=34 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Penile Size After Treatment
After 6 weeks flaccid
|
10.54 cm
Standard Deviation 1.83
|
10.99 cm
Standard Deviation 2.49
|
|
Penile Size After Treatment
After 6 weeks stretched
|
13.46 cm
Standard Deviation 1.81
|
13.4 cm
Standard Deviation 2.58
|
|
Penile Size After Treatment
After 12 weeks flaccid
|
10.46 cm
Standard Deviation 1.74
|
10.99 cm
Standard Deviation 2.49
|
|
Penile Size After Treatment
After 12 weeks stretched
|
13.44 cm
Standard Deviation 1.79
|
13.4 cm
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: BaselineMeasurement of the duration of intercourse from intromission to ejaculation before treatment.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Intra-vaginal Latency Time Before Treatment
IVLT less than 1 minutes
|
12 Participants
|
9 Participants
|
|
Intra-vaginal Latency Time Before Treatment
IVLT from 1 to 3 minutes
|
13 Participants
|
18 Participants
|
|
Intra-vaginal Latency Time Before Treatment
IVLT more than 3 minutes
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after injection.Measurement of the duration of intercourse from intromission to ejaculation after treatment.
Outcome measures
| Measure |
BTX-A Group
n=35 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Intra-vaginal Latency Time After Treatment
After 2 weeks IVLT less than 1 minute
|
12 Participants
|
8 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 2 weeks IVLT between 1 to 3 minutes
|
13 Participants
|
18 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 2 weeks IVLT more than 3 minutes
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 weeks after injection.Population: One patient was dropped out from the treatment group after 2 weeks injection.
Measurement of the duration of intercourse from intromission to ejaculation after treatment.
Outcome measures
| Measure |
BTX-A Group
n=34 Participants
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.
|
Placebo Group
n=35 Participants
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.
|
|---|---|---|
|
Intra-vaginal Latency Time After Treatment
After 6 weeks IVLT less than 1 minute
|
9 Participants
|
8 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 6 weeks IVLT between 1 to 3 minutes
|
15 Participants
|
19 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 6 weeks IVLT more than 3 minutes
|
10 Participants
|
8 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 12 weeks IVLT less than 1 minute
|
9 Participants
|
8 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 12 weeks IVLT between 1 to 3 minutes
|
14 Participants
|
19 Participants
|
|
Intra-vaginal Latency Time After Treatment
After 12 weeks IVLT more than 3 minutes
|
11 Participants
|
8 Participants
|
Adverse Events
BTX-A Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hussein Ghanem, Directer of this clinical trial
Cairo University
Phone: 01001176111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place