A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction (EXSTACY)
2026年5月11日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
157
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Karina Acevedo, Clinical Research Coordinator
- 電話番号：415-353-7615
- メール：Karina.Acevedo@ucsf.edu
研究連絡先のバックアップ
- 名前：Jennette Sison, MPH
- 電話番号：415-885-3692
- メール：Jennette.Sison@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- 募集
- University of California, San Francisco (UCSF)
-
コンタクト：
- Alan W. Shindel, MD, MAS
- 電話番号：415-353-2200
- メール：Alan.Shindel@ucsf.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Shockwave therapy
Once a week for 6 weeks
|
The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Detect clinically meaningful change in IIEF-EFD score for ED: mild, moderate, and severe; which corresponds to 2, 5, and 7 points change, respectively.
時間枠：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.
|
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.
時間枠：6-months post treatment; 12-months post treatment
|
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.
|
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?
時間枠：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.
|
3 months; 6 months; and 12 months (post-treatment)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alan W. Shindel, MD, MAS、University of California, San Francisco
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年9月10日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年4月29日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 23-39009
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
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