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

NCT ID: NCT05646602

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Peyronie Disease Penile Curvature Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Collagenase Clostridium Histolyticum with LiSWT for PD Group

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).

Group Type EXPERIMENTAL

Collagenase Clostridium Histolyticum

Intervention Type DRUG

Intralesional injection

Duolith SD1 T-TOP

Intervention Type DEVICE

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

Collagenase Clostridium Histolyticum for PD Group

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection

Group Type ACTIVE_COMPARATOR

Collagenase Clostridium Histolyticum

Intervention Type DRUG

Intralesional injection

Radial Shockwave Therapy for ED Group

Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.

Group Type ACTIVE_COMPARATOR

Duolith SD1 T-TOP

Intervention Type DEVICE

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

Linear Shockwave Therapy for ED Group

Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy

Group Type EXPERIMENTAL

Duolith SD1 T-TOP

Intervention Type DEVICE

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

Interventions

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Collagenase Clostridium Histolyticum

Intralesional injection

Intervention Type DRUG

Duolith 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

Intervention Type DEVICE

Other Intervention Names

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Xiaflex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Tobias S. Kohler, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tobias Kohler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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22-001663

Identifier Type: -

Identifier Source: org_study_id

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