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Investigating the efficacy of intracavernosal injection of platelet-rich plasma (PRP) in the treatment of erectile dysfunction in diabetic patients with oral treatments-resistent to

Investigating the efficacy of intracavernosal injection of platelet-rich plasma (PRP) in the treatment of erectile dysfunction in diabetic patients resistent to phosphodiesterase type 5 (PDE-5) inhibitors: a randomized controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100817004582N9
Enrollment
58
Registered
2024-07-05
Start date
2024-07-22
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Erectile dysfunction. N52.9

Interventions

Intervention 1: Intervention group: Taking 30 ml of blood from the patient to receive platelet-rich plasma by centrifugation through a standard device, injecting 6 cc of platelet-rich plasma received

Sponsors

Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Non-responder to PDE5Is Having score at least 21 in IIEF questionnair More than 6 months have passed since erectile dysfunction Have at least 10 years of diabets history Having persistent sex in last 3 months

Exclusion criteria

Exclusion criteria: History of using PDE5Is in the last month History of psychological disorders and use of related drugs for its treatment History ofusing energy therapy for erectile dysfunction in the last month History of radiation or penile surgery or having penile prosthesis History of trauma, fracture and pelvic surgery History of priapism, penile fracture and Peyronie's History of using anti-androgen and selective serotonin reuptake inhibitors (SSRIs) Presence of active infection evidence in the injected area Abnormal morning testosterone levels (lower than 200 and above 1197)

Design outcomes

Primary

MeasureTime frame
Erectile function. Timepoint: Before intervention, 1, 3 and 6 months after last injection. Method of measurement: The International Index of Erectile Dysfunction (IIEF) questionnaire.;Erection quality. Timepoint: Before intervention, 1, 3 and 6 months after last injection. Method of measurement: Erectile Hardness Score (EHS) index.

Secondary

MeasureTime frame
Patient satisfaction score of treatment. Timepoint: 1, 3 and 6 months after last injection. Method of measurement: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hossein Shahabi

Urology Research Center, Guilan University of Medical Sciences

urc1384@yahoo.com+98 13 3352 5259

Outcome results

None listed

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