The study is an experimental pre-post-test design involving 10 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.
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
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
Single group
uc-msc secretome intra cavernous injection
Combination productUC-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.
Visual analog scale
A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Hematomes
Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
Bleeding
Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Erection hardness score
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)
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