Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PUTI Q1 | Other Identifier | Universitas Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is an experimental pre-post-test design involving 12 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.
The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe erectile dysfunction non responsive to Sildenafil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome | Biological | UC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg/ml. The intervention was the administration of 0.5 mL/site of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | A visual analog is used for measuring pain. The patient will be asked to describe the pain on scale 1 to 10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome. | one day and one month |
| Hematomes | Hematomes means blue discoloration. 0 scale means ther is no discoloration and 1 means there is discoloration. | one day and one month |
| Bleeding | Bleeding is one of the outcomes of the research. If there is bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0. | one day and one month |
| Erection Hardness Score | Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 scores. 1 indicate severe erectile dysfunction (worst) and 4 indicates there is optimal erection (good). | One month |
| IIEF-5 | Rapid diagnostic tool to evaluate erectile dysfunction | One month |
| Restrictive Index | one month | |
| PSV | one month | |
| SPL | one month | |
| FPL |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male patients with severe erectile dysfunction non-responsive sildenafil
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univesitas Indonesia Hospital | Depok | West Java | 16424 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2025 | Oct 6, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| one month |
| Penile Circumference | one month |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2025 | Oct 6, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2025 | Oct 6, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided