A Study to compare the additive advantage of Platelet rich Plasma in Erectile Dysfucntion.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Platelet rich Plasma to be given intracavernosally in penis.: 30 ml venous blood drawn into TSC vacutainer using an 18‐gauge hypodermic needle. Double‐spin centrifugation method to obtain PRP (soft spin 1500 RPM for 5 min followed by hard spin 2500 RPM for 15 min) 3ml PRP injected intracavernosally (bilateral corpora cavernosa) after application of ice for 1 2 min to decrease pain perception, with a tourniquet for 20 min along with gentle penile massage, followed by compression dressing (till 4 hours post injection). Injections at baseline, 14th day and 28th day . Follow up will be at 1 month after final treatment. Standard treatment to be comprised of Tab Tadalafil 5 mg. Control Intervention1: Standard treatment with PDE 5 inhibitor: Each patient enrolled in study will receive Standard treatment in the form of 5mg PDE 5 inhibitor at bedtime od dose. CONDITION: Health Condition 1: N529‐ Male erectile dysfunction, unspecified PRIMARY OUTCOME: To study the mean change in IIEF‐5 score after PRP injection at 1month after final ; treatment. ; To study the Proportion of patient attaining MCID in the IIEF‐5 score at 1 month after ; final treatment. ; To study the Improvement in EHS score at 1 month after final treatment.Timepoint: Baseline before treatment and 1 month after completion of final treatment. SECONDARY OUTCOME: NILTimepoint: NIL INCLUSION CRITERIA: Inclusion Criteria Adult men aged more than 18 years diagnosed with mild ED IIEF 5 score 17 to 21 and mild to moderate ED IIEF 5 score 12 to 16 Exclusion Criteria Adult men with IIEF 5 score less than 11 severe ED. Patient with history of Penile surgery or significant trauma. Patients with significant Psychological disorders
Epistemonikos ID: 1f4678176e368ca299dc1eb8f3040866eebb5398
First added on: Aug 08, 2026