Intracavernosal injection of platelet rich plasma for treatment of erectile dysfunction

Use of intracavernosal injection of autologous platelet rich plasma for the treatment of mild to moderate erectile dysfunction: A placebo controlled, parallel group, double blind randomized clinical trail - nil

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058110

Enrollment

Registered

2023-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N529- Male erectile dysfunction, unspecified

Interventions

Intervention1: autologous platelet rich plasma: intracavernosal injection of autologous platelet rich plasma Two injections one month apart, followup of 3 month. total study duration one year. Control

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients aged 21-75 years 2. Patients with well-established chronic ED for at least 3 months 3. IIEF-EF score 11-25 at screening (even if taking a single PDE5I) 4. sexually active in a heterosexual stable partnership for at least 3 months will be considered for study 5. Patients must be willing to comply with the key requests of the trial, namely to maintain regular sexual activities during the entire course of the trial with a mean frequency of sexual activities of at least once per week and comply with study related tests and procedures 6. must give up any other EF enhancing treatment, including hormonal (T) replacement therapy with study entrance.

Exclusion criteria

Exclusion criteria: 1. Previous surgery of penile fracture/ hypospadias/penile reconstructive surgery. 2. history of significant psychiatric disease/BPD 3. untreated hypogonadism 4. uncontrolled DM (HBA1c > 9%) 5. patients using intra-cavernosal injection of vasoactive substances for ED 6. developing priapism during before or during study period

Design outcomes

Primary

Measure	Time frame
The achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function - Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment.Timepoint: The achievement of minimal clinically important difference (MCID) in the International Index of Erectile Function Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment.	—

Secondary

Measure	Time frame
Sexual Encounter Profile SEP Questions 2 & 3, EHS (erectile hardness score) increase of one point at 3 & 6 month followup. Change in doppler ultrasound parameters ( Time Frame: Baseline, Up to 29 weeks ) as well as safety of PRP injections (Incidence of adverse events ( Time Frame: 24 weeks ), were also evaluated.Timepoint: exual Encounter Profile SEP Questions 2 & 3, EHS (erectile hardness score) increase of one point at 3 & 6 month followup. Change in doppler ultrasound parameters ( Time Frame: Baseline, Up to 29 weeks ) as well as safety of PRP injections (Incidence of adverse events ( Time Frame: 24 weeks ), were also evaluated.	—

Measure

Time frame

Sexual Encounter Profile SEP Questions 2 & 3, EHS (erectile hardness score) increase of one point at 3 & 6 month followup. Change in doppler ultrasound parameters ( Time Frame: Baseline, Up to 29 weeks ) as well as safety of PRP injections (Incidence of adverse events ( Time Frame: 24 weeks ), were also evaluated.Timepoint: exual Encounter Profile SEP Questions 2 & 3, EHS (erectile hardness score) increase of one point at 3 & 6 month followup. Change in doppler ultrasound parameters ( Time Frame: Baseline, Up to 29 weeks ) as well as safety of PRP injections (Incidence of adverse events ( Time Frame: 24 weeks ), were also evaluated.

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Countries

India

Contacts

Public Contactsatyadeo sharma

AIIMS RAIPUR

satyadeo2004@gmail.com7772967744

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026