Sham-Controlled Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Penile LiSWT

NCT06600893 | Completed FDA Device

• 1 other identifier: SDSM-2019-02.1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Does homogeneity/inhomogeneity of corporal cavernosal tissue improve using Grayscale ultrasound (GUS) when comparing sham to active treatment groups?
• Do peak systolic velocity (PSV) and end diastolic velocity (EDV) improve using color duplex Doppler ultrasound when comparing sham to active treatment groups?
• Do the International Index of Erectile Function (IIEF), its erectile function domain (IIEF-EF) and question 3 of the Sexual Encounter Profile (SEP) improve comparing sham to active treatment groups?

Conditions

Erectile Dysfunctions

Keywords

low intensity shockwave therapy; erectile dysfunction; grayscale ultrasound; duplex Doppler ultrasound; erectile tissue homogeneity/inhomogeneity

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

Secondary Outcomes (3)

• International Index of Erectile Function (IIEF)

  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)

  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)

  Completed over the 4 week screening period, and during the 4 weeks prior to each follow up

Other Outcomes (1)

• International Prostate Symptom Score (IPSS)

  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

Study Arms (4)

Sham Arm 1-Simulated Low Intensity Shockwave Therapy

SHAM COMPARATOR

Using the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, week 3, week 6

Device: Sham

Active Arm 1- Low Intensity Shockwave Therapy

EXPERIMENTAL

Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, week 3, week 6

Device: Low intensity shockwave therapy (LiSWT)

Sham Arm 2 - Simulated Low Intensity Shockwave Therapy

SHAM COMPARATOR

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

Active Arm 2 - Low Intensity Shockwave Therapy

EXPERIMENTAL

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)

Interventions

Low intensity shockwave therapy (LiSWT) DEVICE

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

Active Arm 1- Low Intensity Shockwave Therapy; Active Arm 2 - Low Intensity Shockwave Therapy

Sham DEVICE

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.

Sham Arm 1-Simulated Low Intensity Shockwave Therapy; Sham Arm 2 - Simulated Low Intensity Shockwave Therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Participants had to be anatomically a male and identity as a male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
• Subject is male;
• Subject is aged 21-80 years;
• Subject is in a relationship with a female partner for at least 3 months;
• Subject has a body mass index (BMI) \< 37 kg/m2;
• Subject has erectile dysfunction;
• Subject has testosterone ≥ 300;
• Subject has a prostate specific antigen (PSA) \< 4.0;
• Subject is willing to attempt sexual activity at least 4 times during the screening period and 4 weeks before each follow-up visit;
• Subject is willing to stop all erectile function aids (e.g. prescription and non-prescription medications, injections, vacuum erection devices, constriction ring) during the screening period and 4 weeks before each follow-up visit;
• Subject agrees to comply with the study procedures and visits.

You may not qualify if:

• Subject has been treated with acoustic wave previously;
• Subject has a pacemaker or implanted defibrillator;
• Subject has clinically significant findings on physical examination;
• Subject has sciatica or severe back pain;
• Subject has uncontrolled hypertension;
• Subject has uncontrolled hypogonadism;
• Subject is unwilling to maintain testosterone replacement therapy if currently using testosterone to treat hypogonadism;
• Subject scores ≥ 26 on the IIEF;
• Subject has homogenous corpora cavernosa on grey scale ultrasound;
• Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes him ineligible for the study;
• Subject has lesions or active infections on the penis or perineum;
• Subject is unwilling to remove piercings from the genital region;
• Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
• Subject has received an investigational drug within 30 days prior to signing consent;
• Subject has received platelet rich plasma (PRP) within 3 months of signing consent;

Sponsors & Collaborators

• San Diego Sexual Medicine: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Related Publications (8)

• Kitrey ND, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y, Gruenwald I. Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last? J Urol. 2018 Jul;200(1):167-170. doi: 10.1016/j.juro.2018.02.070. Epub 2018 Mar 1.

  PMID: 29477719 BACKGROUND

• Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012.

  PMID: 28673433 BACKGROUND

• Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1.

  PMID: 29396020 BACKGROUND

• Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.

  PMID: 30664671 BACKGROUND

• Sokolakis I, Dimitriadis F, Teo P, Hatzichristodoulou G, Hatzichristou D, Giuliano F. The Basic Science Behind Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Scoping Review of Pre-Clinical Studies. J Sex Med. 2019 Feb;16(2):168-194. doi: 10.1016/j.jsxm.2018.12.016.

  PMID: 30770067 BACKGROUND

• Rizk PJ, Krieger JR, Kohn TP, Pastuszak AW. Low-Intensity Shockwave Therapy for Erectile Dysfunction. Sex Med Rev. 2018 Oct;6(4):624-630. doi: 10.1016/j.sxmr.2018.01.002. Epub 2018 Mar 22.

  PMID: 29576441 BACKGROUND

• Ruffo A, Capece M, Prezioso D, Romeo G, Illiano E, Romis L, Di Lauro G, Iacono F. Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction. Int Braz J Urol. 2015 Sep-Oct;41(5):967-74. doi: 10.1590/S1677-5538.IBJU.2014.0386.

  PMID: 26689523 BACKGROUND

• Goldstein SW, Kim NN, Goldstein I. Randomized trial of low intensity shockwave therapy for erectile dysfunction utilizing grayscale ultrasound for analysis of erectile tissue homogeneity/inhomogeneity. Transl Androl Urol. 2024 Oct 31;13(10):2246-2267. doi: 10.21037/tau-24-338. Epub 2024 Oct 28.

  PMID: 39507857 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Irwin Goldstein, MD

  San Diego Sexual Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant is placed behind a screen wearing headphones so they cannot see if the noise of shocking is coming from the shockwave device or from the recording playing on a bluetooth speaker as applicator is placed on the various locations for treatment with energy or simulated sham treatment without energy. Outcomes are assessed without identification of whether the assessment is after active or sham treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sham group crosses over to active treatment while active group does a second follow up assessment without additional treatment intervention

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: August 5, 2019
• Primary Completion: June 22, 2022
• Study Completion: April 7, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)