RECRUITING

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

Official Title

Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial

Quick Facts

Study Start:2024-01-19

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06065436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Prior intralesional injections or surgery for PD. * Severe baseline penile pain. * Moderate or severe baseline ED based on IIEF-EF domain. * History of low intensity shockwave therapy for sexual dysfunction (ED or PD). * Ventral (downward) or ventrolateral penile curvature. * Moderate or severe (grade 2/3) plaque calcification as determined by PDDU. * Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Prior intralesional injections or surgery for PD.
* Severe baseline penile pain.
* Moderate or severe baseline ED based on IIEF-EF domain.
* History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
* Ventral (downward) or ventrolateral penile curvature.
* Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
* Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.

Contacts and Locations

Study Contact

Wyatt H Anians, CCRP

CONTACT

507-538-6151

Anians.Wyatt@mayo.edu

Principal Investigator

Tobias Kohler, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Tobias Kohler, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-19

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-01-19

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Peyronie Disease
Erectile Dysfunction