A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction

NCT07592533 | Recruiting FDA Device

• 1 other identifier: 23-39009
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; Shockwave therapy; Single-arm study

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (3)

• Detect clinically meaningful change in IIEF-EFD score for ED: mild, moderate, and severe; which corresponds to 2, 5, and 7 points change, respectively.

  3 months post-treatment

• 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.

  6-months post treatment; 12-months post treatment

• 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?

  3 months; 6 months; and 12 months (post-treatment)

Study Arms (1)

Shockwave therapy

EXPERIMENTAL

Once a week for 6 weeks

Device: Shockwave therapy

Interventions

Shockwave therapy DEVICE

The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.

Shockwave therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 35319291 BACKGROUND

• 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.

  PMID: 20451317 BACKGROUND

• 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.

  PMID: 30120384 BACKGROUND

• 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.

  PMID: 23253086 BACKGROUND

• 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.

  PMID: 15740982 BACKGROUND

• 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.

  PMID: 23698784 BACKGROUND

• 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.

  PMID: 28258952 BACKGROUND

• 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.

  PMID: 26755082 BACKGROUND

• 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.

  PMID: 26383610 BACKGROUND

• 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.

  PMID: 19614917 BACKGROUND

• 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.

  PMID: 26522972 BACKGROUND

• 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.

  PMID: 29414942 BACKGROUND

• 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.

  PMID: 22575596 BACKGROUND

• 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.

  PMID: 27986492 BACKGROUND

• 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.

  PMID: 25274132 BACKGROUND

• 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.

  PMID: 17145991 BACKGROUND

• 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.

  PMID: 30956690 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Alan W. Shindel, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Acevedo, Clinical Research Coordinator

CONTACT

415-353-7615; Karina.Acevedo@ucsf.edu

Jennette Sison, MPH

CONTACT

415-885-3692; Jennette.Sison@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm study where all eligible patients will receive the treatment.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 18, 2026
• Study Start: September 10, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)