An interventional study of Low intensity shockwave therapy (LiSWT) and Sham in Erectile Dysfunctions, sponsored by San Diego Sexual Medicine. Completed at 1 site in United States. Open to male participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by San Diego Sexual Medicine · Not applicable, Interventional, and Treatment
The primary goal of this single blind, prospective sham-controlled clinical trial is to assess safety and efficacy of low intensity shockwave therapy (LiSWT) to improve erectile function in men 21-80 years of age with erectile dysfunction naive to radial ballistic acoustic wave and LiSWT. The main questions it aims to answer are:
This is a single site sham-controlled clinical trial to be conducted at San Diego Sexual Medicine in San Diego, California. Subjects meeting inclusion and exclusion criteria will be randomized to one of two arms, each 2:1 active to sham, treated in 3-week cycles. Arm 1 consists of 5000 shocks the first week and two weeks off for each of three treatment cycles. Arm 2 is made up of 5000 shocks the first week and 3000 active shocks the second and third weeks followed by three weeks without treatment, and then 5000, 3000 and 3000 shocks again over the next three weeks. Each of these is followed by the first follow-up visit at 20 weeks after the first treatment, when GUS and DUS is repeated and validated instruments completed, at which time treatment will be unblinded. SEP diaries will be completed during sexual activity in the screening period and during the 4 weeks prior to the follow up visit. Those subjects assigned to sham will be crossed over to the opposite arm for active treatment (arm 1 sham goes to arm 2 open label and arm 2 sham to arm 1 open label) and begin active treatment with decreased intervals between shocks and therefore decreased number of shocks needed, with 3500 rather than 5000 shocks and 2000 rather than 3000 shocks at a lower frequency at that visit after completing the follow up procedures. Subjects assigned initially to the active arm will have a second follow up 32 weeks after the first treatment, and complete SEP diaries during the 4 weeks preceding this visit. GUS and DUS is performed and validated instruments completed at the last follow up.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →San Diego Sexual Medicine is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Using the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, week 3, week 6
Device: Sham
Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, week 3, week 6
Device: Low intensity shockwave therapy (LiSWT)
Using the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, 3000 week 1, 3000 week 3, 5000 week 6, 3000 week 7, 3000 week 8
Device: Sham
Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, 3000 week 1, 3000 week 3, 5000 week 6, 3000 week 7, 3000 week 8
Device: Low intensity shockwave therapy (LiSWT)
The Urogold100™ uses electrohydraulic technology to generate low intensity shockwave energies in ranges of 0.1 - 0.18 mJ/mm2 (using 0.9 - 0.12 mJ/mm2 in this study) associated with biologic activities of stimulation of mechanosensors, activation of neo-angiogenesis processes, recruitment and activation of stem cell progenitor cells, improvement of microcirculation, nerve regeneration, remodeling of erectile tissue with increase in the muscle/collagen ratio and reducing inflammatory and cellular stress responses. The device uses the parabolic applicator OP 155 that generates a plasma-driven detonation resulting in a shockwave with a broad and widely-stretched 5 megapascal therapeutic volume. Due to the absence of a concentrated focus, a 14 mm wide shockwave is delivered to the erectile tissue with up to 30 mm penetration. LiSWT is delivered to Active Arms 1 and 2 per protocol. After unblinding at the first follow up visit, participants in Sham Arms 1 and 2 receive active LiSWT treatment
Also known as: SoftWave TRT/UroGold 100MTS, Parabolic applicator OP 155
With the Urogold 100 turned on and with the participant wearing headphones and blinded by a pulled curtain the applicator is applied in a similar manner to when it is active treatment and the sound of shockwave playing in a blue tooth speaker the participant believes he is receiving active treatment but zero energy is delivered.
Grayscale ultrasound (GUS)
Changes from low intensity shockwave treatment using Grayscale ultrasound to assess erectile tissue homogeneity of the corpora cavernosa comparing sham and active treatment groups
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Duplex Doppler ultrasound (DUS)
Changes from low intensity shockwave treatment in peak systolic velocity (PSV) and end diastolic velocity (EDV) using color duplex Doppler ultrasound comparing sham and active treatment groups
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
International Index of Erectile Function (IIEF)
Changes in IIEF, a validated patient reported outcome instrument used to assess sexual function will be compared from baseline to both follow up visit. This has a 4 week recall.
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
IIEF Erectile Function Domain (IIEF-EF)
Changes in the erectile function domain, IIEF-EF, used specifically to assess erectile function, will be compared from baseline to both follow up visit. This is a 4 week recall.
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Sexual Encounter Profile (SEP)
The SEP diary is a standard assessment completed by a participant after each attempt at sexual activity.
Time frame: Completed over the 4 week screening period, and during the 4 weeks prior to each follow up
International Prostate Symptom Score (IPSS)
The IPSS is a validated patient reported outcome instrument to assesses lower urinary tract symptoms, comparing baseline to follow up visits in active and sham groups.
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Plan to share: No — The research is from a small medical practice without the manpower, financial or technical support from a larger institution or industry to enter data into a data repository.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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San Diego Sexual Medicine