Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment

25. juli 2012 oppdatert av: Rambam Health Care Campus

Efficacy and Safety of a Second Series of Low Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.

Studieoversikt

Detaljert beskrivelse

The patients will be selected out of the patients with Erectile Dysfunction who received Low intensity shock waves and Were Partial Responders to the treatment.

At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form. The patient's general medical condition and any problems related to sexual dysfunction are already known from the previous study he was participating. Also the patient's sexual function is already known by sexual function questionnaires that were filled out in previous study. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. Then shall the patient obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), if he did not do so of some reason after ending the previous study, then it would be the first visit (Visit 1). At visit 1 The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of visit 1 the patient will begin Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). Four weeks after the treatment series ends the patient will come for another visit and will be asked to fill in questionnaires and perform the FMD and/or Doppler ultrasound test again. The patient's ED condition will be followed up for a long term after the end of his participation in the study.

Studietype

Intervensjonell

Registrering (Forventet)

300

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Haifa, Israel
        • Rambam Health Care Campus

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  1. Incomplete response to active treatment (not placebo) on first round but patient is still unsatisfied.
  2. Recurring ED (had improved on first round of shock wave therapy but after a certain period of time became clinically worse again) after shock wave therapy.
  3. A minimum of two sexual attempts per month.
  4. An IIEF-ED domain score ≤ 25 post screening, with or without PDE5i intake according to assessment on final visit of Shockwave previous treatment.
  5. A stable heterosexual relationship with the same partner for more than three months

Exclusion Criteria:

  1. Subjects that did not respond at all to the first round as well as those that did not respond sufficiently.
  2. Any pelvic surgery during the period after the first round.
  3. Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities arising during this period .
  4. cardiovascular conditions that prevent sexual activity.
  5. Recent Use of anti-androgens, or oral or injectable androgens
  6. Recent hormonal, neurologic, or psychological pathology

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Åpen etikett
We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.
Andre navn:
  • Cardiospec 1000

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
IIEF-ED Domain score
Tidsramme: 3 months
Severe ED (6≤IIEF-ED Domain score≤10): an increase of 7 points and above; Moderate ED (11≤IIEF-ED Domain score≤16): an increase of 5 points and above; Mild ED (17≤IIEF-ED Domain score≤25): an increase of 2 points and above.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rigidity Score Questionaire
Tidsramme: 3 months
An increase of at least 1 point is considered as a treatment success.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ilan Gruenwald, MD, Rambam Health Care Campus
  • Studieleder: Yoram Vardi, Prof. MD, Rambam Health Care Campus

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2012

Primær fullføring (Forventet)

1. juli 2014

Studiet fullført (Forventet)

1. januar 2015

Datoer for studieregistrering

Først innsendt

15. mai 2012

Først innsendt som oppfylte QC-kriteriene

16. mai 2012

Først lagt ut (Anslag)

17. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 0179-12-RMB

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Erektil dysfunksjon

Abonnere