Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, Platelet-Rich Plasma, Tadalafil, Intracavernosal Injection, Penile Duplex Doppler Ultrasound, International Index of Erectile Function, Phosphodiesterase Type 5 Inhibitor Nonresponse
Brief summary
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.
Interventions
DRUGTadalafil
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.
PROCEDUREIntracavernosal Platelet-Rich Plasma Injection
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in a one-to-one ratio to one of two parallel treatment arms. One arm received intracavernosal platelet-rich plasma injections combined with oral tadalafil 5 milligrams once daily, while the other arm received intracavernosal platelet-rich plasma injections alone. Participants remained in their assigned treatment group throughout the study follow-up period.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men aged 18 years or older. * Diagnosis of mild to mild-moderate erectile dysfunction according to the International Index of Erectile Function-5. * Inadequate response to previous phosphodiesterase type 5 inhibitor treatment. * Eligible for intracavernosal platelet-rich plasma injection. * Eligible for oral tadalafil treatment. * Baseline penile duplex Doppler ultrasound assessment available.
Exclusion criteria
* Severe erectile dysfunction. * Peyronie's disease. * Previous major pelvic surgery. * Previous pelvic trauma. * Known bleeding or coagulation disorder. * Contraindication to phosphodiesterase type 5 inhibitors, including nitrate therapy. * Significant cardiac disease contraindicating tadalafil use. * Total testosterone less than 300 nanograms per deciliter. * Refusal or inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Index of Erectile Function-5 Score | Baseline, 1 month, 3 months, and 6 months after treatment initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penile Peak Systolic Velocity | Baseline and 6 months after treatment initiation | 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. |
| Change in Penile End-Diastolic Velocity | Baseline and 6 months after treatment initiation | End-diastolic velocity was measured by penile duplex Doppler ultrasound after pharmacologic stimulation. It was used to assess venous outflow status during erection. |
| Change in Penile Resistive Index | Baseline and 6 months after treatment initiation | 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. |
Countries
Egypt
Outcome results
None listed