Umbilical Cord Mesenchymal Stem Cell Secretome Administration in Severe Erectile Dysfunction Non-… (NCT07245875) | Clinical Trial Compass
CompletedNot Applicable
Umbilical Cord Mesenchymal Stem Cell Secretome Administration in Severe Erectile Dysfunction Non-responsive to Sildenafil
Indonesia12 participantsStarted 2024-04-12
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexMALE
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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 c…