Intracavernosal Exosomes vs. Rectal Ozone for Post-RARP Erectile Dysfunction (REHAB-RARP)
11. juli 2026 opdateret af: Ali Ihsan Memmi, Medipol University
Intracavernosal Exosomes Versus Rectal Ozone Therapy for Erectile Dysfunction Following Robotic-Assisted Radical Prostatectomy
This prospective, randomized, controlled trial aims to evaluate and compare the therapeutic efficacy of intracavernosal urine-derived exosomes and systemic rectal ozone therapy in patients experiencing erectile dysfunction (ED) post-robotic-assisted radical prostatectomy (RARP).
Patients will be randomized into two distinct intervention arms.
The primary objective is to assess the functional recovery of the erectile tissue via the International Index of Erectile Function (IIEF-5) over a 6-month follow-up period.
Secondary endpoints include penile hemodynamic alterations and overall health-related quality of life.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
Erectile dysfunction (ED) remains a prevalent and distressing complication following robotic-assisted radical prostatectomy (RARP), primarily manifesting secondary to cavernous nerve neuropraxia, subsequent localized hypoxia, and fibrotic remodeling of the corpus cavernosum.
While standard pharmacotherapies (e.g., PDE5 inhibitors) offer symptomatic relief, they fail to reverse the underlying endothelial and neural detriments.Recent preclinical and clinical data suggest that stem cell-derived therapies, particularly cell-free exosomes, exhibit significant proangiogenic and antifibrotic properties.
Extracellular vesicles containing components of the stem cell secretome, such as microRNAs, facilitate endothelial cell proliferation and tissue repair.
Conversely, systemic ozone therapy has been hypothesized to enhance oxygen delivery, upregulate antioxidant enzymes, and modulate inflammatory cascades, potentially mitigating post-surgical ischemia.
In this trial, eligible post-RARP patients will be randomized (1:1) to receive either a targeted intracavernosal injection of urine-derived exosomes (USC-Exos) or a scheduled regimen of rectal ozone-oxygen mixture insufflation.
Erectile capacity, penile vascular hemodynamics (assessed via pharmacopenile duplex ultrasonography), and general health status will be prospectively monitored at baseline, 3, and 6 months post-intervention.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ali ihsan Memmi
- Telefonnummer: 90 537 999 0941
- E-mail: alimemmi@gmail.com
Studiesteder
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Başakşehir
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Istanbul, Başakşehir, Tyrkiet (Türkiye)
- Başakşehir Çam Sakura City Hospital
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Kontakt:
- Ali ihsan Memmi
- Telefonnummer: 905379220997
- E-mail: alimemmi@gmail.com
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Ledende efterforsker:
- Ali ihsan Memmi, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- History of Robotic-Assisted Radical Prostatectomy (ns-RARP) for localized prostate cancer.
- Normal preoperative erectile function (retrospective IIEF-5 score > 21).
- Presence of a stable, sexually active heterosexual relationship.
- Inadequate response or intolerance to maximum dose, on-demand oral Phosphodiesterase type 5 inhibitors (PDE5i).
Exclusion Criteria:
- History of adjuvant or salvage pelvic radiotherapy / androgen deprivation therapy (ADT).
- Presence of severe anatomical penile deformities (e.g., active phase Peyronie's disease).
- Uncontrolled endocrinological (e.g., HbA1c > 8.5%) or cardiovascular comorbidities.
- History of major cardiovascular events (myocardial infarction, stroke) within the preceding 6 months.
- Current use of systemic anticoagulants (excluding low-dose prophylactic aspirin).
- Concomitant use of any intraurethral alprostadil, vacuum erection devices (VED), or testosterone replacement therapy during the study period.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intracavernosal Urine-Derived Exosomes (USC-Exos)
Participants randomized to this arm will receive targeted intracavernosal injections of cell-free, urine-derived exosomes.
The intervention aims to evaluate the proangiogenic and regenerative effects of the exosome secretome on the cavernous tissue following radical prostatectomy.
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A single (or protocol-specified sequenced) bilateral intracavernosal injection of a sterile, cell-free urine-derived exosome suspension (e.g., 2 cc) into the corpus cavernosum, performed under clinical setting conditions.
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Eksperimentel: Rectal Medical Ozone Therapy
Participants randomized to this arm will receive protocolized systemic rectal medical ozone insufflation.
This arm evaluates the systemic antioxidant, anti-inflammatory, and tissue oxygenation benefits of ozone therapy on post-operative erectile functional recovery.
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Administration of a standardized medical ozone and oxygen gas mixture (e.g., 30-40 µg/mL concentration) via rectal insufflation.
The treatment will be administered for a predetermined number of sessions (e.g., 10 sessions spanning over 5 weeks) using a certified medical ozone generator.
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Aktiv komparator: Standard Penile Rehabilitation
Participants randomized to this arm will receive the current standard of care for post-prostatectomy penile rehabilitation.
This serves as the active control group to benchmark the efficacy of the experimental regenerative therapies.
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Oral administration of a daily low-dose PDE5 inhibitor (e.g., Tadalafil 5 mg once daily) for a continuous duration of 6 months, aligning with standard clinical guidelines for post-operative erectile dysfunction management.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Change in International Index of Erectile Function (IIEF-5) Score
Tidsramme: Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.
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The International Index of Erectile Function (IIEF-5) is a validated self-reporting psychometric instrument utilized to assess erectile function severity.
The total score ranges from a minimum of 5 to a maximum of 25.
Higher scores represent better erectile function (a better outcome), with scores ≤21 indicating varying degrees of erectile dysfunction and 22-25 representing normal erectile function.
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Baseline, 3 Months Post-Intervention, and 6 Months Post-Intervention.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Peak Systolic Velocity (PSV)
Tidsramme: Baseline and 6 Months Post-Intervention.
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Objective measurement of cavernous arterial competence following an intracavernosal injection of a vasoactive agent, assessed via Pharmacopenile Duplex Ultrasonography (PPDU).
Reported in centimeters per second (cm/s).
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Baseline and 6 Months Post-Intervention.
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Change in End-Diastolic Velocity (EDV)
Tidsramme: Baseline and 6 Months Post-Intervention.
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Objective measurement of the cavernous veno-occlusive mechanism following an intracavernosal injection of a vasoactive agent, assessed via Pharmacopenile Duplex Ultrasonography (PPDU).
Reported in centimeters per second (cm/s).
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Baseline and 6 Months Post-Intervention.
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Change in Resistive Index (RI)
Tidsramme: Baseline and 6 Months Post-Intervention.
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Calculated ratio based on the peak systolic and end-diastolic velocities, used to evaluate penile vascular resistance via Pharmacopenile Duplex Ultrasonography (PPDU).
It is reported as a unitless ratio.
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Baseline and 6 Months Post-Intervention.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. januar 2027
Studieafslutning (Anslået)
1. april 2027
Datoer for studieregistrering
Først indsendt
17. maj 2026
Først indsendt, der opfyldte QC-kriterier
11. juli 2026
Først opslået (Faktiske)
16. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1453145315453
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