Platelet-rich plasma is being studied as a regenerative treatment option for erectile dysfunction, but it is unclear whether adding daily tadalafil gives additional benefit over platelet-rich plasma alone. This study evaluates adult men with mild to mild-moderate erectile dysfunction who had an inadequate response to previous phosphodiesterase type 5 inhibitor treatment. Participants were randomly assigned to receive either intracavernosal platelet-rich plasma injections combined with oral tadalafil 5 milligrams once daily, or intracavernosal platelet-rich plasma injections alone. The platelet-rich plasma injection protocol consisted of three intracavernosal treatment sessions spaced two weeks apart. Erectile function was assessed using the International Index of Erectile Function-5 questionnaire at baseline and during follow-up at 1, 3, and 6 months. Penile duplex Doppler ultrasound was performed at baseline and after 6 months to assess erectile blood-flow parameters. The study hypothesis is that adding daily tadalafil to intracavernosal platelet-rich plasma may produce greater improvement in patient-reported erectile function compared with platelet-rich plasma alone, while also allowing assessment of whether this improvement is accompanied by measurable changes in penile Doppler parameters. The study included 156 participants in the final analysis, with 78 participants in each treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Tadalafil was administered orally as a 5 milligram tablet once daily in combination with intracavernosal platelet-rich plasma injections. It was used as adjunct pharmacologic therapy to support erectile function during the study follow-up period.
Autologous platelet-rich plasma was prepared from whole blood using a two-step centrifugation technique and activated with calcium chloride before administration. It was injected intracavernosally using a fine-gauge needle after topical local anesthesia. The treatment protocol included three intracavernosal injection sessions spaced two weeks apart.
Benha University Hospital
Banhā, Qalyubia Governorate, Egypt
Change in International Index of Erectile Function-5 Score
Erectile function was assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. Scores were compared over time between the platelet-rich plasma plus tadalafil group and the platelet-rich plasma alone group.
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment initiation
Change in Penile Peak Systolic Velocity
Peak systolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess arterial penile blood flow. Higher values indicate better arterial inflow.
Time frame: Baseline and 6 months after treatment initiation
Change in Penile End-Diastolic Velocity
End-diastolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess venous outflow status during erection.
Time frame: Baseline and 6 months after treatment initiation
Change in Penile Resistive Index
Resistive index was calculated from penile duplex Doppler ultrasound parameters after pharmacologic stimulation. It was used as an additional measure of penile vascular resistance and erectile hemodynamics.
Time frame: Baseline and 6 months after treatment initiation
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