Diabetes Mellitus Type 2, Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, non responsive to sildenafil, secretome, Umbilical Cord Mesenchymal Stem Cell
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALIntracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome
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.
Sponsors
Indonesia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo. * Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7 * History of undergoing treatment with sildenafil 100 mg for four sessions. * Evaluation of IIEF-5 score \< 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4 * Type II Diabetes Melitus with an HbA1c test result of \< 7%. * Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits. * Patients with undergoing treatment with antidepressant.
Exclusion criteria
* Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin. * Active and significant systemic or local infection. * History of bleeding or blood clotting disorder therapy. * History of systemic autoimmune disorders and immunosuppressive treatment * History of prostate surgery, history of malignancy, or a PSA level \> 4 ng/mL. * Untreated hypogonadism or low serum total testosterone (\<200 ng/dL). * Uncontrolled hypertension or hypotension (systolic blood pressure \>170 or \<90 mmHg, and diastolic blood pressure \>100 or \<50 mmHg). * Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | one day and one month | 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. |
| Hematomes | one day and one month | Hematomes means blue discoloration. 0 scale means ther is no discoloration and 1 means there is discoloration. |
| Bleeding | one day and one month | 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. |
| Erection Hardness Score | One month | 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). |
| IIEF-5 | One month | Rapid diagnostic tool to evaluate erectile dysfunction |
| Restrictive Index | one month | — |
| PSV | one month | — |
| SPL | one month | — |
| FPL | one month | — |
| Penile Circumference | one month | — |
Countries
Indonesia
Outcome results
None listed