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| Name | Class |
|---|---|
| Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials | OTHER |
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The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volus | Experimental | Maxium: 22ml |
|
| Powerfill | Active Comparator | Maxium: 22ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volus/Powerfill | Device | Maximum: 22ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control. | Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention. | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control. | baseline, 4 weeks, 12 weeks, 24 weeks | |
| The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUGEL | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30833149 | Derived | Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2. |
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| baseline, 4 weeks, 12 weeks, 24 weeks |
| The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control. | baseline, 12 weeks, 24 weeks |
| The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control. | † penile length: A length of penile distribution measured from the ventral side of pubo-penile skin junction to the apex of prepuce when relaxed using a tape( or stick)- measure. | baseline, 4 weeks, 12 weeks, 24 weeks |