Comparsion of Effect of PRP,PDE5 Inhibitor in Treatment of Erectile Dysfunction
Comparison Between The Effect of Intracavernosal Injection of Platelet-Rich Plasma as a Single Agent vs Daily Oral 5 Phosphodiesterase Inhibitor Intake as a Single Agent Vs Combination In Improving of Erectile Dysfunction
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.Erectile dysfunction (ED) is one of the commonest disorders in adult males and affects 12-19% of men of reproductive age.Erectile dysfunction can be due to vasculogenic, neurogenic, hormonal, veno-occlusive, psychogenic and/or pharmacogenic factors.
PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation. PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) leading to dilatation of the penile arteries leads to a more prolonged erection.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.The prevalence of erectile dysfunction (ED) increases with age, from 5% in men aged 20-39 years to 70% in men aged >70 years.
PDE5Is inhibit the enzyme phosphodiesterase-5 (PDE-5) present in the smooth muscle cells of the vessels. By inhibiting this enzyme, these drugs prevent the degradation of cGMP by PDE-5. GMP can cause activation of protein kinase G, leading to relaxation of the vascular smooth muscle. Prevention of degradation of cGMP by PDE-5 leads to the accumulation of cGMP in the vascular smooth muscle, thereby leading to dilatation of the blood vessels through phosphorylation of different downstream effector molecules. Dilatation of the penile arteries leads to a more prolonged erection. In addition, PDE5Is improve endothelial function and reduce apoptosis of vascular smooth muscle cells in the corpus cavernosum.
PRP is autologous plasma that has a platelet concentration above the concentrations typically found in whole blood and is derived from the patient's own blood (autologous) through a process of centrifugation.PRP has 7 fundamental proteins: platelet derived growth factors (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and adhesive proteins - fibrin, fibronectin and vitronectin.
PDGF is a glycoprotein, which emerges from degranulation of platelets at the site of injection. It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds, which activates the signal proteins to initiate specific activity of target cells. These specific activities include mitogenesis, angiogenesis.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Studienorte
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Abbasia
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Cairo, Abbasia, Ägypten
- Ain Shams University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Agree to attempt sexual intercourse at least 3 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
- Agree to comply with all study related tests/procedures.
- provide written informed consent.
Exclusion Criteria:
- Previous penile surgery of any kind (except circumcision ).
- Previous history of penile fracture or priapism.
- Psychogenic ED as determined by study investigator.
- Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity).
- Patients using Intracavernosal Injection (ICI) for management of ED.
- Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
- Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
- Any history of significant psychiatric disease.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: INTRACAVERNOSAL PRP
About 25 patients suffering from Erectile Function and underwent Intracaveronsal injection of 7-9 ml of PRP for 3 times 4weeks apart
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To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
Andere Namen:
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Aktiver Komparator: 5 phosphodiasterase inhibitor
About 25 patients suffering from Erectile Function and took a daily dose of oral 5 mg tadalafil tablets
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To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
Andere Namen:
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Aktiver Komparator: Prp and 5 phosphodiasterase inhibitor combined
About 25 patients suffering from Erectile Function and underwent combined of both agents which includes daily dose of oral 5mg tadalafil tablets and Intracaveronsal injection of 7-9 ml of PRP for 3 injections 4 weeks apart
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To compare between Intra Cavernous Injection of Platelet Rich Plasma (PRP) as a single agent , 5 PDE inhibitor as a single agent vs combined effect of two agent to achieve an efficient therapy with less cost for the treatment of Erectile Dysfunction.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Treatment of Erectile Dysfunction
Zeitfenster: 6 Months
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Treatment of the patients whom suffering from Erectile Dysfunction by using Intracavernosal Injection of Platelet-Rich Plasma as a single agent and daily oral 5 Phosphodiesterase Inhibitor intake as a single agent and combination of both agents evaluated by International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF).
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6 Months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Hisham Mohamed Fathy Salama El Shawaf, Professor, Professor of Urology, faculty of Medicine, Ain Shams University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Psychische Störungen
- Genitalerkrankungen, männlich
- Männliche Urogenitalerkrankungen
- Sexuelle Dysfunktion, Physiologisch
- Sexuelle Dysfunktionen, Psychisch
- Erektile Dysfunktion
- Pyridinen
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Indolen
- Indolalkaloide
- Heterocyclische Verbindungen, 3-Ring
- Carboline
- Tadalafil
Andere Studien-ID-Nummern
- PRP in Erectile dysfunction
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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