Platelet-Rich Plasma With or Without Tadalafil for Erectile Dysfunction

Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized Study

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 Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Tadalafil; Procedure: Intracavernosal Platelet-Rich Plasma Injection

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13511
      • Benha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-Rich Plasma Plus Tadalafil; Participants received intracavernosal platelet-rich plasma injections combined with oral tadalafil. Tadalafil was given as 5 milligrams tablet by mouth once daily. Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia. The injection protocol consisted of three treatment sessions spaced two weeks apart.	Drug: Tadalafil; 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.; Procedure: Intracavernosal 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.
Active Comparator: Platelet-Rich Plasma Alone; Participants received intracavernosal platelet-rich plasma injections alone without adjunct oral tadalafil. Platelet-rich plasma was prepared from autologous whole blood using a two-step centrifugation method, activated with calcium chloride, and injected intracavernosally using a fine-gauge needle after topical local anesthesia. The injection protocol consisted of three treatment sessions spaced two weeks apart.	Procedure: Intracavernosal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 month, 3 months, and 6 months after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 6 months after treatment initiation

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 16, 2025

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Tadalafil; Platelet-Rich Plasma; Intracavernosal Injection; Penile Duplex Doppler Ultrasound; International Index of Erectile Function; Phosphodiesterase Type 5 Inhibitor Nonresponse
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indole Alkaloids; Heterocyclic Compounds, 3-Ring; Carbolines; Tadalafil
• Other Study ID Numbers: MD 5-10-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, International Index of Erectile Function-5 scores, and penile duplex Doppler ultrasound parameters. No directly identifying participant information will be shared.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
• IPD Sharing Access Criteria: Data will be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the study investigators. Data will be provided only after approval of the request and, when required, completion of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No