A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction (EXSTACY)
11. mai 2026 oppdatert av: University of California, San Francisco
A Single Arm Study of EXtracorporeal Shockwave Therapy for mAnagement of ereCtile dYsfunction (EXSTACY Study)
This is a device study (while the device has been patented and cleared by the FDA, the indication of the use for Erectile Dysfunction has been yet approve).
EXSTACY is a study to collect information on which patients who have trouble getting or keeping an erection rigid enough for sex (sometimes known as Erectile Dysfunction or ED) benefit from light intensity shockwave therapy (LI-SWT).
LI-SWT is a form of energy transfer to the penis that has been shown to help some men with ED in studies over the past decade.
This study will collect information about patients prior to treatment to determine what predicts a good outcome.
The investigators hope that this information will help decide which patients are likely to benefit from LI-SWT and which patients should consider other treatments for ED.
Studieoversikt
Detaljert beskrivelse
Upon signed informed consent, an eligible patient participant with ED is enrolled in the study. Each patient will be asked to complete a series of questionnaires, blood tests, and a non-invasive assessment of blood vessel function using a device called EndoPAT at the initial Baseline Visit. The patients will receive a series of 6 LI-SWT sessions administered to the penis and perineum (the area between the scrotum and anus). A brief survey to assess for any adverse reactions/events will be asked between treatment sessions and follow-up time points at 3, 6, and 12 months from the date of the initial Baseline Visit. Additionally, patients will complete another set of questionnaires at 3, 6, and 12 months from the date of the initial Baseline Visit.
EndoPAT® (Itamar Medical Inc., Atlanta, GA) is an FDA-cleared device designed for the non-invasive assessment of endothelial function and overall arterial health. EndoPAT has been used in prior studies as a way to understand blood flow in men with ED. EndoPAT testing takes about 15-25 minutes and involves assessment of blood flow in the fingers after release of a blood pressure cuff that is tightly applied around the arm.
The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study. UroGold100™ is a patented shockwave generator that has been used in clinical practice at numerous centers around the country. A standardized protocol for SWT using this device has been patented as well. The device is cleared by the FDA for activation of connective tissue, improved blood supply, and temporary relief of pain. LI-SWT using the Urogold100™ protocol takes about 15 minutes and involves application of shockwave energy to the shaft of the penis and the perineum (area between scrotum and anus) on both sides.
Studietype
Intervensjonell
Registrering (Antatt)
157
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Karina Acevedo, Clinical Research Coordinator
- Telefonnummer: 415-353-7615
- E-post: Karina.Acevedo@ucsf.edu
Studer Kontakt Backup
- Navn: Jennette Sison, MPH
- Telefonnummer: 415-885-3692
- E-post: Jennette.Sison@ucsf.edu
Studiesteder
-
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California
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San Francisco, California, Forente stater, 94143
- Rekruttering
- University of California, San Francisco (UCSF)
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Ta kontakt med:
- Alan W. Shindel, MD, MAS
- Telefonnummer: 415-353-2200
- E-post: Alan.Shindel@ucsf.edu
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patient is over the age of 18
- Patient has a natal penis (not a neophallus)
- Patient has ED (defined as IIEF-EF of 25 or less) and EHS < 2 on at least 50% of sexual encounters
- Patient understands and is able to articulate necessary study procedures and tests
- Patient has the mental capacity to provide written and verbal informed consent
- Patient endorses the ability to comply with study procedures throughout the duration of the study
Exclusion Criteria:
- Placement of a penile prosthesis (malleable or inflatable type)
- Have a serious medical condition/illness that makes safety or compliance with study procedures and/or engagement in sexual activity inadvisable in the opinion of the PI
- Untreated severe psychological disease (e.g., psychosis, bipolar disorder)
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 |
|---|---|
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Eksperimentell: Shockwave therapy
Once a week for 6 weeks
|
The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinically noticeable improvement of ED detected by a change of 4 points in the International Index of Erectile Dysfunction - Erectile Function Domain score or IIEF-EFD score
Tidsramme: 3 months post-treatment
|
Compare IIEF-EFD score at Baseline with IIEF-EFD score reported at 3-months (post-treatment) to see if there is a change of 4 points which corresponds to significant improvement in erectile function.
|
3 months post-treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Detect clinically meaningful change in IIEF-EFD score for ED: mild, moderate, and severe; which corresponds to 2, 5, and 7 points change, respectively.
Tidsramme: 3 months post-treatment
|
Compare IIEF-EFD score at Baseline with IIEF-EFD score reported at 3-months (post-treatment) to detect a change in the severity of ED.
The IIEF-EFD is divded into severity scores, with 25+ (normal); 18-24 (mild); 11-17 (moderate), and <10 (severe).
A clinically significant improvement for each category will be 2 points for mild; 5 points for moderate; and 7 points for severe ED when comparing IIEF-EFD scores at 3-months post treatment with Baseline scores.
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3 months post-treatment
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Review IIEF-EFD scores at later time-points to check if the change in score remains consistent. This may indicate a durability (lasting effect) of ED improvement over time.
Tidsramme: 6-months post treatment; 12-months post treatment
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Compare IIEF-EFD score at Baseline with IIEF-EFD score reported at 6-months and 12-months post treatment to detect if the change in points remains consistent; with a 4-point change indicating significant improvement of ED over time.
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6-months post treatment; 12-months post treatment
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Is there clinically noticeable ED improvement detected by a change of 4 points in the IIEF-EFD score between men who had radical prostatectomy (RP) or radiation therapy versus men who did not receive RP or radiation therapy?
Tidsramme: 3 months; 6 months; and 12 months (post-treatment)
|
Compare the IIEF-EFD scores at Baseline and time-points: 3-mo, 6-mo, and 12-mo in men who received RP or radiation therapy to see if there is a change of 4 points at the three later time-points.
Calculate the IIEF-EFD in men who did not receive RP or radiation therapy at the same time-points to see if there is a difference.
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3 months; 6 months; and 12 months (post-treatment)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Alan W. Shindel, MD, MAS, University of California, San Francisco
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
- Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
- Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.
- Aicher A, Heeschen C, Sasaki K, Urbich C, Zeiher AM, Dimmeler S. Low-energy shock wave for enhancing recruitment of endothelial progenitor cells: a new modality to increase efficacy of cell therapy in chronic hind limb ischemia. Circulation. 2006 Dec 19;114(25):2823-30. doi: 10.1161/CIRCULATIONAHA.106.628623. Epub 2006 Dec 4.
- Sokolakis I, Dimitriadis F, Psalla D, Karakiulakis G, Kalyvianakis D, Hatzichristou D. Effects of low-intensity shock wave therapy (LiST) on the erectile tissue of naturally aged rats. Int J Impot Res. 2019 May;31(3):162-169. doi: 10.1038/s41443-018-0064-0. Epub 2018 Aug 17.
- Lin G, Reed-Maldonado AB, Wang B, Lee YC, Zhou J, Lu Z, Wang G, Banie L, Lue TF. In Situ Activation of Penile Progenitor Cells With Low-Intensity Extracorporeal Shockwave Therapy. J Sex Med. 2017 Apr;14(4):493-501. doi: 10.1016/j.jsxm.2017.02.004. Epub 2017 Mar 1.
- Mariotto S, Cavalieri E, Amelio E, Ciampa AR, de Prati AC, Marlinghaus E, Russo S, Suzuki H. Extracorporeal shock waves: from lithotripsy to anti-inflammatory action by NO production. Nitric Oxide. 2005 Mar;12(2):89-96. doi: 10.1016/j.niox.2004.12.005.
- Liu J, Zhou F, Li GY, Wang L, Li HX, Bai GY, Guan RL, Xu YD, Gao ZZ, Tian WJ, Xin ZC. Evaluation of the effect of different doses of low energy shock wave therapy on the erectile function of streptozotocin (STZ)-induced diabetic rats. Int J Mol Sci. 2013 May 21;14(5):10661-73. doi: 10.3390/ijms140510661.
- Kuo YR, Wang CT, Wang FS, Chiang YC, Wang CJ. Extracorporeal shock-wave therapy enhanced wound healing via increasing topical blood perfusion and tissue regeneration in a rat model of STZ-induced diabetes. Wound Repair Regen. 2009 Jul-Aug;17(4):522-30. doi: 10.1111/j.1524-475X.2009.00504.x.
- Yao H, Wang X, Liu H, Sun F, Tang G, Bao X, Wu J, Zhou Z, Ma J. Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction. Am J Mens Health. 2022 Mar-Apr;16(2):15579883221087532. doi: 10.1177/15579883221087532.
- Qiu X, Lin G, Xin Z, Ferretti L, Zhang H, Lue TF, Lin CS. Effects of low-energy shockwave therapy on the erectile function and tissue of a diabetic rat model. J Sex Med. 2013 Mar;10(3):738-46. doi: 10.1111/jsm.12024. Epub 2012 Dec 17.
- Li H, Matheu MP, Sun F, Wang L, Sanford MT, Ning H, Banie L, Lee YC, Xin Z, Guo Y, Lin G, Lue TF. Low-energy Shock Wave Therapy Ameliorates Erectile Dysfunction in a Pelvic Neurovascular Injuries Rat Model. J Sex Med. 2016 Jan;13(1):22-32. doi: 10.1016/j.jsxm.2015.11.008.
- Lei H, Xin H, Guan R, Xu Y, Li H, Tian W, Wang L, Gao Z, Guo Y, Lue TF, Lin G, Xin Z. Low-intensity Pulsed Ultrasound Improves Erectile Function in Streptozotocin-induced Type I Diabetic Rats. Urology. 2015 Dec;86(6):1241.e11-8. doi: 10.1016/j.urology.2015.07.026. Epub 2015 Sep 14.
- Jeon SH, Shrestha KR, Kim RY, Jung AR, Park YH, Kwon O, Kim GE, Kim SH, Kim KH, Lee JY. Combination Therapy Using Human Adipose-derived Stem Cells on the Cavernous Nerve and Low-energy Shockwaves on the Corpus Cavernosum in a Rat Model of Post-prostatectomy Erectile Dysfunction. Urology. 2016 Feb;88:226.e1-9. doi: 10.1016/j.urology.2015.10.021. Epub 2015 Oct 29.
- He L, Si G, Huang J, Samuel ADT, Perrimon N. Mechanical regulation of stem-cell differentiation by the stretch-activated Piezo channel. Nature. 2018 Mar 1;555(7694):103-106. doi: 10.1038/nature25744. Epub 2018 Feb 7.
- Hausner T, Pajer K, Halat G, Hopf R, Schmidhammer R, Redl H, Nogradi A. Improved rate of peripheral nerve regeneration induced by extracorporeal shock wave treatment in the rat. Exp Neurol. 2012 Aug;236(2):363-70. doi: 10.1016/j.expneurol.2012.04.019. Epub 2012 May 1.
- Abe Y, Ito K, Hao K, Shindo T, Ogata T, Kagaya Y, Kurosawa R, Nishimiya K, Satoh K, Miyata S, Kawakami K, Shimokawa H. Extracorporeal low-energy shock-wave therapy exerts anti-inflammatory effects in a rat model of acute myocardial infarction. Circ J. 2014;78(12):2915-25. doi: 10.1253/circj.cj-14-0230. Epub 2014 Oct 2.
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 (Faktiske)
10. september 2024
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
29. april 2026
Først innsendt som oppfylte QC-kriteriene
11. mai 2026
Først lagt ut (Faktiske)
18. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Psykiske lidelser
- Kjønnssykdommer, mannlige
- Mannlige urogenitale sykdommer
- Seksuell dysfunksjon, fysiologisk
- Seksuelle dysfunksjoner, psykologiske
- Erektil dysfunksjon
- Terapeutikk
- Fysioterapi -modaliteter
- Rehabilitering
- Ultrasonisk terapi
- Diatermi
- Hypertermi, indusert
- Ekstrakorporeal sjokkwaveterapi
Andre studie-ID-numre
- 23-39009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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