Low Intensity Shockwave Therapy for Erectile Dysfunction

NCT04434352 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB-HSR# 190082
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of North America and American Urological Association have put forth guideline statements recommending additional investigation of this treatment modality.2 The current clinical armamentarium only treats the symptoms of erectile dysfunction without improving upon the underlying pathophysiology. LiSWT has been used effectively in musculoskeletal disorders and cardiovascular applications. Animal studies have shown improvements in angiogenesis and stem cell recruitment in other systems (cardiac and musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction since 2010 and is widely used in Europe and throughout the world. It is gaining widespread acceptance in the United States with a relative paucity of data in regards to its effectiveness. While the majority of studies and meta-analyses show improvements in standardized erectile dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In addition, many studies have failed to assess a population of men who have highly prevalent erectile dysfunction, those men undergoing prostate cancer treatment. This is a prospective, randomized, single blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED patients in three distinct patient populations. LiSWT has shown the potential to improve baseline erectile function but requires further study, which is the aim of this investigation.

Conditions

Erectile Dysfunction; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Following Radiation Therapy; Erectile Dysfunction Due to General Medical Condition; Erectile Dysfunction Due to Arterial Insufficiency

Outcome Measures

Primary Outcomes (1)

• Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment

  The primary outcome will be change in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) score from baseline (pre-treatment) to 1 month after the end of treatment. The IIEF/SHIM score is a validated instrument to assess erectile function. Over the past 6 months: 1. How do you rate your confidence that you could keep an erection? 2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)? 3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? 4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? 5. When you attempted sexual intercourse, how often was it satisfactory for you? Each item is scored 1-5, with a higher number indicating better rigidity.

  1 month

Secondary Outcomes (3)

• Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment

  3 and 6 months

• Adverse Event Rates

  1, 3 and 6 months

• Change in Erection Hardness Score at 1, 3, and 6 months

  1, 3, and 6 months

Study Arms (3)

Baseline Erectile Dysfunction

ACTIVE COMPARATOR

The first arm of the study will be those men with erectile dysfunction as defined by IIEF score. These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM score and EHS score. Each questionnaire is described in the trial description with a higher score indicating improved function.

Device: Storz Duolith Low-Intensity Shockwave Therapy

Erectile Dysfunction-Penile Rehabilitation

ACTIVE COMPARATOR

The second population of patients will be those who are planning to undergo treatment for prostate cancer. In a similar manner, men will be randomized to either the Sham or active treatment groups. Men will be treated prior to undergoing definitive treatment for prostate cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to prostate cancer treatment.

Device: Storz Duolith Low-Intensity Shockwave Therapy

Erectile Dysfunction Post-Prostate Cancer Treatment

ACTIVE COMPARATOR

The third population of patients will be those who have undergone treatment for prostate cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone prostatectomy or radiation therapy. Again, there will be a sham and treatment group.

Device: Storz Duolith Low-Intensity Shockwave Therapy

Interventions

Storz Duolith Low-Intensity Shockwave Therapy DEVICE

A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete. B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete.

Also known as: Sham

Baseline Erectile Dysfunction; Erectile Dysfunction Post-Prostate Cancer Treatment; Erectile Dysfunction-Penile Rehabilitation

Eligibility Criteria

• Age: 30 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be willing and able to provide informed consent.
• The patient is a male between \>30 and \<80 years of age.
• PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 2 weeks before baseline IIEF.
• Baseline IIEF-EF score ≥ 8 and ≤21. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF.
• Testosterone level \> 300 ng/dL. This includes patients on therapeutic testosterone therapy.
• If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment.
• Men who have undergone radical prostatectomy ≥ 12 months ago
• Men who have undergone radiation therapy, either brachytherapy or external bean therapy ≥ 12 months ago

You may not qualify if:

• History of extensive pelvic surgery ever.
• Past radiation therapy of the pelvic region within 12 months prior to enrollment.
• Recovering from any non-prostate related cancer within 12 months prior to enrollment.
• Neurological disease which affects erectile function at the discretion of the investigator.
• Anatomical malformation of the penis, including Peyronie's disease.
• Testosterone level \<300 within 3 month prior to enrollment.
• HgbA1C level \> 7.5% within 3 month prior to enrollment.
• History of spinal cord injury.
• Recovering from any non-prostate cancer malignancy within 12 months prior to enrollment.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

• Lange M, Charles D, Kazeem A, Jones M, Sun F, Ghosal S, Krzastek S, Rapp D, Ortiz N, Smith R. Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?-long-term outcomes of a randomized sham-controlled trial. Transl Androl Urol. 2024 Oct 31;13(10):2194-2200. doi: 10.21037/tau-24-329. Epub 2024 Oct 28.

  PMID: 39507860 DERIVED

• Kennady EH, Bryk DJ, Ali MM, Ratcliffe SJ, Mallawaarachchi IV, Ostad BJ, Beano HM, Ballantyne CC, Krzastek SC, Clements MB, Gray ML, Rapp DE, Ortiz NM, Smith RP. Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial. Sex Med. 2023 Nov 11;11(5):qfad053. doi: 10.1093/sexmed/qfad053. eCollection 2023 Oct.

  PMID: 37965376 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized to either the treatment group or sham group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: June 1, 2020
• Primary Completion: December 10, 2024
• Study Completion: January 9, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)