NCT06469775

Brief Summary

The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are:

  1. 1.Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
  2. 2.What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy?

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
64mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Mar 2025Sep 2031

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

April 11, 2025

Status Verified

June 1, 2024

Enrollment Period

4.5 years

First QC Date

June 17, 2024

Last Update Submit

April 8, 2025

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Sexual Health Inventory for Men (SHIM)

    The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction.

    Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)

Secondary Outcomes (1)

  • Erection Hardness Score

    Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)

Study Arms (2)

LiSWT

EXPERIMENTAL

men receiving LiSWT

Device: Low intensity shock wave

Control

ACTIVE COMPARATOR

Standard of care: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, penile implant.

Combination Product: Control

Interventions

Low intensity shock waveDEVICE

6 sessions of low intensity shock wave therapy, applied in 15 minute appointments once weekly.

Also known as: MoreNova
LiSWT
ControlCOMBINATION_PRODUCT

Standard of care treatment: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, and penile implant.

Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male sex presenting with mild to severe erectile dysfunction for at least six months, as defined by SHIM score 1-21 and/or an EHS 0-3
  • Age \>18
  • Ability to make independent decisions (sign own consent)

You may not qualify if:

  • Men reliant on penile injections for erections
  • Men with current penile implant
  • Prisoners
  • Current anticoagulant / anti-platelet therapy
  • Adults who cannot make their own medical decisions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (3)

  • Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.

    PMID: 8254833BACKGROUND

  • Zanaty F, Badawy A, Kotb H, Elsarfy F, Salman B. Efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand tadalafil for erectile dysfunction. Arab J Urol. 2022 Jun 24;20(4):189-194. doi: 10.1080/2090598X.2022.2090134. eCollection 2022.

    PMID: 36353469BACKGROUND

  • 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.

    PMID: 35319291BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Danielle Velez Leitner, MD

    Rutgers Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

March 1, 2025

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2031

Last Updated

April 11, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)