Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction

Impact of Focused Low-intensity Shockwave Therapy (LiSWT) in Penile Disorders (Peyronie's Disease, Erectile Dysfunction, or Both), With or Without Intralesional Clostridial Collagenase (Xiaflex) Injection, Compared With Radial Shock Wave Therapy or Xiaflex Therapy

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05646602

Enrollment

Registered

2022-12-12

Start date

2023-03-31

Completion date

2024-12-31

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Penile Curvature, Peyronie Disease

Brief summary

The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).

Interventions

DRUGCollagenase Clostridium Histolyticum

Intralesional injection

DEVICEDuolith SD1 T-TOP

Delivers low-intensity shockwave therapy, six sessions (once/week) of 2000 shockwaves per session with a constant energy flux density of 0.29 mJ/mm2 and frequency of 3 Hz

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Following enrollment men will be randomized based on the severity of their penile curvature. Separate randomization tables will be established for men with penile curvature (i) 30 to \< 60 degrees and (ii) 60-90 degrees. Patients will be randomized in a 1:1 ratio to CCH + LiSWT versus CCH alone within each severity cohort, with the intention to enroll a similar number of patients within each severity group

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Peyronie's Disease (PD) at any stage * The presence of penile plaque or pain at erection or curvature * PD therapy with or without simultaneous intralesional Xiaflex injection.

Exclusion criteria

* Prior penile surgery or LiSWT. * Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections. * Unwillingness or inability to provide informed consent. * Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications

Design outcomes

Primary

Measure	Time frame	Description
Change in penile curvature	Baseline, 10 weeks	Measured with a goniometer after artificial erection reported in degree unit of measurements

Secondary

Measure	Time frame	Description
Change in Sexual function	Baseline, 10 weeks	Measured using the Sexual Encounter Profile (SEP) questions 2 and 3 to assess functional outcomes on a scale of 0=no sexual activity/did not attempt intercourse; 1=almost never/never; 2=A few times (much less than half the time); 3=Sometimes (about half the time); 4=Most times (much more than half the time); 5=Almost always/always
Change in penile length	Baseline, 10 weeks	—
Li-SWL related pain at therapy sessions	6 weeks	Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026