Peyronie DiseaseNCT05646602
Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction
A study testing Collagenase Clostridium Histolyticum and Duolith SD1 T-TOP in people with Peyronie Disease and Penile Curvature, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie Disease, Penile Curvature, Erectile Dysfunction
- What is being tested?
- Collagenase Clostridium Histolyticum and Duolith SD1 T-TOP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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
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).
- Conditions
- Peyronie Disease, Penile Curvature, Erectile Dysfunction
- Being tested
- Collagenase Clostridium Histolyticum, Duolith SD1 T-TOP
- Medical subject headings
- Penile Induration, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium HistolyticumDrug
Also called Xiaflex
Intralesional injection
Duolith SD1 T-TOPDevice
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 group | Role | What they receive |
|---|---|---|
| Collagenase Clostridium Histolyticum with LiSWT for PD Group | Experimental | Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT). Receives: Drug: Collagenase Clostridium Histolyticum; Device: Duolith SD1 T-TOP |
| Collagenase Clostridium Histolyticum for PD Group | Active comparator | Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection Receives: Drug: Collagenase Clostridium Histolyticum |
| Radial Shockwave Therapy for ED Group | Active comparator | Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy. Receives: Device: Duolith SD1 T-TOP |
| Linear Shockwave Therapy for ED Group | Experimental | Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy Receives: Device: Duolith SD1 T-TOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in penile curvature
Measured with a goniometer after artificial erection reported in degree unit of measurements
Measured: Baseline, 10 weeks
Secondary outcomes (3)
Change in Sexual function
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
Measured: Baseline, 10 weeks
Change in penile length
Measured: Baseline, 10 weeks
Li-SWL related pain at therapy sessions
Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study startMar 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias S. Kohler, MD, MPH, Mayo Clinic
- Investigators
- Tobias Kohler, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646602
- Sponsor's protocol ID
- 22-001663
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05646602
- Acronym / sponsor ID
- 22-001663
- Conditions
- Peyronie Disease, Penile Curvature, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Collagenase Clostridium Histolyticum with LiSWT for PD Group | Experimental | Drug: Collagenase Clostridium Histolyticum, Device: Duolith SD1 T-TOPSubjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT). |
| Collagenase Clostridium Histolyticum for PD Group | Active comparator | Drug: Collagenase Clostridium HistolyticumSubjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection |
| Radial Shockwave Therapy for ED Group | Active comparator | Device: Duolith SD1 T-TOPSubjects being treated for erectile dysfunction (ED) will have radial shockwave therapy. |
| Linear Shockwave Therapy for ED Group | Experimental | Device: Duolith SD1 T-TOPSubjects being treated for erectile dysfunction (ED) will have linear shockwave therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium HistolyticumAlso: XiaflexIntralesional injection | Drug | Collagenase Clostridium Histolyticum for PD Group, Collagenase Clostridium Histolyticum with LiSWT for PD Group |
| Duolith SD1 T-TOPDelivers 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 | Device | Collagenase Clostridium Histolyticum with LiSWT for PD Group, Linear Shockwave Therapy for ED Group, Radial Shockwave Therapy for ED Group |
Primary outcome
Change in penile curvature
Time frame: Baseline, 10 weeks
Measured with a goniometer after artificial erection reported in degree unit of measurements
3 secondary outcomes
Change in Sexual function
Time frame: Baseline, 10 weeks
Change in penile length
Time frame: Baseline, 10 weeks
Li-SWL related pain at therapy sessions
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Kohler, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagenase Clostridium Histolyticum and Duolith SD1 T-TOP in people with Peyronie Disease and Penile Curvature, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in penile curvature (time frame: Baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.