Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Treatment of Erectile Dysfunction After Radical Prostatectomy With Platelet-Rich Plasma Injections: a Randomized Controlled Trial
This study will test whether injections of platelet-rich plasma (PRP) can improve erectile function in men with persistent erectile dysfunction (ED) at least 12 months after nerve-sparing radical prostatectomy for prostate cancer. Participants will be randomly assigned to receive either two PRP injections or two saline (placebo) injections into the penis, administered one month apart in a double-blind fashion. Erectile function will be assessed using the International Index of Erectile Function (IIEF) questionnaire at baseline and at 1, 3, 6, and 12 months after the last injection. The primary objective is to determine whether PRP improves the erectile function domain of the IIEF more than saline at one month after the last injection
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Erectile dysfunction is common after nerve-sparing radical prostatectomy and may persist despite recovery from the initial nerve injury. Platelet-rich plasma (PRP) is prepared from autologous blood and contains growth factors that may promote angiogenesis and tissue regeneration. Preclinical studies suggest that PRP may improve erectile function after cavernous nerve injury, but PRP remains an experimental treatment, and no published study has specifically evaluated its effect in men with erectile dysfunction following radical prostatectomy.
The hypothesis is that intracavernosal PRP injections improve erectile function more than saline injections in men with erectile dysfunction persisting 1-3 years after nerve-sparing radical prostatectomy.
Eligible participants will be stratified according to unilateral or bilateral nerve-sparing surgery and randomized 1:1 to receive two intracavernosal injections of either autologous PRP or saline, administered one month apart. An unblinded team member who has no direct interaction with participants will prepare the injections. The participant and the physician administering the injection will remain blinded to treatment allocation. Syringes will be covered with opaque material to maintain blinding.
Blood will be collected before each injection in all participants. For participants assigned to PRP, the blood will be used to prepare the treatment. For the first 10 participants assigned to saline, PRP will also be prepared and analysed to verify the platelet concentration achieved with the preparation procedure. Blood collected from the remaining participants assigned to saline will be discarded.
Participants must discontinue other treatments for erectile dysfunction for four weeks before baseline and until the assessment one month after the last injection. Thereafter, other treatments for erectile dysfunction will be permitted and recorded.
Erectile function and other study outcomes will be assessed at baseline and at 1, 3, 6, and 12 months after the last injection. The primary outcome is the between-group difference in change from baseline in the erectile function domain of the International Index of Erectile Function at one month after the last injection.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Frederikke Bay Toft, MD
- Telefonnummer: +4538689927
- E-mail: frederikke.bay.toft.01@regionh.dk
Studiesteder
-
-
-
Herlev, Danmark, 2730
- Department of Urology, Herlev and Gentofte Hospital
-
Kontakt:
- Mette LK Schmidt, PDH
- Telefonnummer: +4538681100
- E-mail: Mette.Ladefoged.Kopp.Schmidt@regionh.dk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age 40-75 years
- Underwent unilateral or bilateral nerve-sparing radical prostatectomy between 1 and 3 years prior to the study
- Good erectile function prior to surgery (IIEF-EF score ≥ 22)
- Erectile dysfunction at inclusion with an IIEF-EF score < 22 without aids
- Acceptance of a pause in other treatments for erectile dysfunction from 4 weeks before baseline (wash-out) until the 1-month follow-up after the last injection
- In a stable relationship lasting at least 6 months with a desire for sexual activity
- Able to understand and accept the study protocol
Exclusion Criteria:
- Known psychiatric, neurological and/or endocrinological disease requiring medication (including hypogonadism with total testosterone <12 nmol/l).
- Severe urinary incontinence preventing sexual activity (assessed by a physician at inclusion)
- Clinical or biochemical recurrence of prostate cancer
- Other surgery or radiation therapy in the pelvic region
- Severe cardiac disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or severe symptomatic and/or significant valvular disease
- Use of anti-androgen medication
- Peyronie's disease and/or previous episodes of priapism
- Excessive alcohol consumption (more than 21 units per week)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Platelet Rich Plasma (PRP)
A volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections |
A volume of 5 mL PRP will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections
Andre navne:
|
|
Andet: Saline Solution (Placebo)
A volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections. |
A volume of 5 mL saline solution will be administered in corpus cavernosum on two occasions, with a 1-month interval between injections.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in IIEF-EF score from baseline to 1 month after the final treatment session
Tidsramme: From baseline to 1 month post the last intervention
|
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using an intention-to-treat analysis. |
From baseline to 1 month post the last intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in IIEF-EF score at 1 month after the final treatment session - per-protocol analysis
Tidsramme: From baseline to 1 month post the last intervention
|
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 1 month after the final treatment session. The change in IIEF-EF score will be compared between the PRP and saline groups using a per-protocol analysis. |
From baseline to 1 month post the last intervention
|
|
Change in IIEF-EF score at 3, 6, and 12 months after the final treatment session
Tidsramme: From baseline to 12 months post the last intervention
|
Change in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) from baseline to 3, 6, and 12 months after the final treatment session. Analyses will be performed using both intention-to-treat and per-protocol populations, comparing the PRP and saline groups. |
From baseline to 12 months post the last intervention
|
|
Analyses of participants achieving a clinically significant improvement in IIEF-EF score at 1, 3, 6, and 12 months
Tidsramme: From baseline to 12 months post the last intervention
|
Intention-to-treat and per-protocol analyses of the proportion of participants achieving clinically significant improvements in IIEF-EF at 1, 3, 6, and 12 months following the final treatment session with PRP or saline. Clinically significant improvement is defined according to Rosen et al. as an increase of 2 points for mild ED, 5 points for moderate ED, and 7 points for severe ED |
From baseline to 12 months post the last intervention
|
|
Change in IIEF domain scores at 1, 3, 6, and 12 months
Tidsramme: From baseline to 12 months post the last intervention
|
Changes in the remaining domains of the International Index of Erectile Function (IIEF): orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. As no minimum clinically important difference has been established for these domains, changes in domain scores will be analysed as continuous variables and compared between the PRP and saline groups. |
From baseline to 12 months post the last intervention
|
|
Participant satisfaction after treatment
Tidsramme: From baseline to 12 months post last intervention
|
Subjective participant satisfaction following treatment, assessed using the Global Satisfaction Question. This analysis will be performed according to the intention-to-treat principle. |
From baseline to 12 months post last intervention
|
|
Use of additional treatments for erectile dysfunction
Tidsramme: Until 12 months post last intervention.
|
Use of additional treatments for erectile dysfunction during the study period, including oral medication, intraurethral treatment, intracavernosal injections, vacuum erection devices, and penile implants. The use of additional treatments will be compared between the PRP and saline groups. |
Until 12 months post last intervention.
|
|
Treatment effect according to baseline severity of erectile dysfunction, evaluated by the International Index of Erectile Function-Erectile Function (IIEF-EF)
Tidsramme: From baseline to 12 months post last intervention
|
Subgroup analyses of treatment effects according to severity of erectile dysfunction at baseline (International Index of Erectile Function-Erectile Function (IIEF-EF), recorded just before the first injection). These analyses will be considered exploratory and hypothesis-generating. |
From baseline to 12 months post last intervention
|
|
Adverse events following treatment
Tidsramme: From baseline to 12 months post last intervention
|
Incidence and type of adverse events following PRP and saline injections during the study period. All adverse events will be recorded and described in the final study manuscript. |
From baseline to 12 months post last intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mikkel Fode, MD, PhD, Herlev and Gentofte Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-25034065
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .