Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder
10 september 2026 uppdaterad av: HUNG PUI LONG WILSON, The University of Hong Kong
Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder: A Randomized-Controlled Trial
The goal of this clinical trial is to assess the efficacy and safety of linear piezoelectric Li-SWT for erectile dysfunction patients who have poor treatment respond from PDE5i oral treatment. Participants will be randomised to either receive 4 cycles, once per week, of Li-SWT treatment on the penis or the Sham group, where the treatment appears to be identical but the shockwave machine is deactivated. Investigators will compare the before and after treatment erectile function using the IIEF questionnaire of the two groups 1 month after treatment to assess the treatment outcome. After that, the Sham group patient would be offered to receive compensatory Li-SWT treatment and their post treatment response will be assessed.
All the patients completing the Li-SWT treatment will be followed up at 6 and 12 months to assess the efficacy and adverse events.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Dr Hung, MBBS
- Telefonnummer: 852-22554852
- E-post: hpl826@ha.org.hk
Studieorter
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-
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Hong Kong, Hong Kong
- Rekrytering
- Queen Mary Hospital
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Kontakt:
- Dr Hung, MBBS
- Telefonnummer: 852-22554852
- E-post: hpl826@ha.org.hk
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Huvudutredare:
- Pui Long Wilson Hung, MBBS
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Male
- Age 30-80 years
- ED for at least 6 months, defined by IIEF-EF score 8-21 (moderate - mild)
- Sexually active in a stable, heterosexual relationship of more than 3 months duration.
- Agree to comply with all study related tests/procedures
- Morning serum testosterone >12nmol/L
- Inadequate response after at least 4 attempts using highest tolerated PDE5i
Exclusion Criteria:
- Previous penile surgery (e.g. penile lengthening, penile cancer surgery, penile plication, grafting, penile implant).
- Previous history of priapism or penile fracture
- Morning serum testosterone level <12nmol/L
- Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded
- Psychogenic ED as determined by study investigator
- Anatomical (Peyronie's Disease or penile curvature) abnormality
- Neurological disease (Parkinson's, spinal cord injury)
- Anti-coagulation therapy and/or INR >1.5 (Patients on aspirin are eligible) 7
- Current or prior history of sexually transmitted disease
- Tumor tissue/Treatment for cancer in the penile or pelvic region in past 5 years
- Electronic devices implanted in the body (e.g. cardiac pacemaker, deep brain stimulator, spinal cord neurostimulator etc.)
- Any other medical conditions or medical history that are deemed unsafe or high risk for the study treatment per investigator's discretion
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: LiSWT
LiSWT with 8Hz, 0.16 mJ/mm2, wave focus penetration depth 10-15mm at corpora cavernosa (2000 shock), crus of the penis (2000 shock), Once per week for 4 weeks
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LiSWT with 8Hz, 0.16 mJ/mm2, wave focus penetration depth 10-15mm at corpora cavernosa (2000 shock), crus of the penis (2000 shock), Once per week for 4 weeks
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Sham Comparator: Sham
Sham comparator with the device deactivated
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Sham low-intensity shockwave therapy with device deactivated
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of men with improvement in International Index of Erectile Function (IIEF) score at 1 month after traetment
Tidsram: 1 month after Sham/LiSWT
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Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction.
This outcome measure reports the proportion of participants achieving an improvement in IIEF score compared to baseline.
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1 month after Sham/LiSWT
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function (IIEF) score
Tidsram: 1 month
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The International Index of Erectile Function (IIEF) is a self-administered questionnaire used to assess erectile function.Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction.
This outcome measure reports the proportion of participants achieving a minimal clinically important difference (MCID) in the IIEF-5 score compared to baseline.
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1 month
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Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 and 12 months after treatment
Tidsram: 6 and 12 months after treatment
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IIEF is a self-administered questionnaire used to assess erectile function.
Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction.
This outcome measure reports the proportion of participants achieving a minimal clinically important difference (MCID) in the IIEF-5 score compared to baseline.
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6 and 12 months after treatment
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Erectile hardness score (EHS) at 1,6, 12 months after treatment
Tidsram: 1, 6, 12 months after LiSWT treatment
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vertical score assessing penile hardness on a 4-point single-item scale ranging from 1 to 4, where 1 indicates "penis is larger, but not hard" and 4 indicates "penis is completely hard and fully rigid."
Higher scores indicate better erectile function/rigidity.
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1, 6, 12 months after LiSWT treatment
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Side effects and safety profile
Tidsram: From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment
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e.g.
tolerability, pain using the visual analogue scale, bleeding, bruising, penile plaque, penile deformity Safety and tolerability will be evaluated by recording the incidence, severity, and type of all treatment-related adverse events.
Pain will be assessed using a Visual Analogue Scale (VAS), a single-item numeric scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain intensity.
Specific adverse events evaluated include penile pain, bleeding, bruising, formation of penile plaque, and penile deformity.
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From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
7 januari 2026
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 mars 2027
Studieregistreringsdatum
Först inskickad
24 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 september 2026
Första postat (Faktisk)
15 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LiSWTED
Plan för individuella deltagardata (IPD)
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