Sikkerhet og effektivitet av VERTICA® RF-enheten for behandling av ED
Sikkerhet og effektivitetsvurdering av VERTICA® - en radiofrekvensenhet for behandling av erektil dysfunksjon
Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Newport Beach, California, Forente stater, 92660
- University of California, Irvine Medical Center
-
San Diego, California, Forente stater, 92120
- San Diego Sexual Medicine
-
-
Florida
-
Aventura, Florida, Forente stater, 33180
- Optimal Health Miami
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20814
- Rachel Rubin MD
-
-
Ohio
-
Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adult, heterosexual, males between 22 and 85 years of age
- Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).
- Subjects with an IIEF-EF score between 11-21
- Steady relationship for at least 3 months
- Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month
- Subject is willing to sign informed consent and follow study protocol procedures
- Subject has a smartphone
Exclusion Criteria:
- Castrate and late onset hypogonadism
- History of Priapism or Peyronie's Disease
- Surgery or radiotherapy of the pelvic region
- Anatomic penile deformations or penile prosthesis
- Treatment with antiandrogens
- Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)
- History of urothelial or colorectal cancer
- Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy
- Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days
- Subjects who are taking anticoagulation or anti-platelet therapy
- History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
- Subjects who are incarcerated
- Subjects who are cognitively challenged
- Serious heart or lung disease
- Pregnant partner
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Aktiv
|
VERTICA device with a therapeutic RF energy level |
|
Sham-komparator: Sham
|
VERTICA device with a low, non-therapeutic RF energy level |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
A significant difference in the mean change from baseline in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, between the treatment groups.
Tidsramme: 12 weeks
|
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning. |
12 weeks
|
|
A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.
Tidsramme: 12 weeks
|
The IIEF-EF total score ranges between 6 to 30. A higher total score indicates relatively better erectile functioning. |
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- URN-2022
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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