Peyronie DiseaseNCT06065436
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
A study testing Collagenase Clostridium Histolyticum and Storz Duolith LiSWT in people with Peyronie Disease and Erectile Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie Disease, Erectile Dysfunction
- What is being tested?
- Collagenase Clostridium Histolyticum and Storz Duolith LiSWT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with PD
- Palpable penile plaque
- Dorsal, lateral, or dorsolateral penile curvature
- Penile curvature > 30 degrees and < 90 degrees as measured using goniometer during objective curvature assessment
- Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
- "Stable PD symptoms' defined as PD symptom duration > 6-months or stable symptoms > 3-months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Carter Day, 507-422-5076, Day.Carter@mayo.edu
About this study
Official title: Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
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.
- Conditions
- Peyronie Disease, Erectile Dysfunction
- Being tested
- Collagenase Clostridium Histolyticum, Storz Duolith LiSWT
- 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
Total of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart.
Storz Duolith LiSWTDevice
Single low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks/minute and using a power setting of 0.09 mJ/mm2. These treatments will occur four separate times, before each of the four separate CCH injection series.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy | Experimental | Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT). Receives: Drug: Collagenase Clostridium Histolyticum; Device: Storz Duolith LiSWT |
| Collagenase Clostridium Histolyticum | Active comparator | Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care. Receives: Drug: Collagenase Clostridium Histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom bother
Measured using the validated Peyronie's Disease Questionnaire (PDQ) subdomain symptom bother. Four questions to evaluate pain or discomfort during vaginal intercourse: responses include "not at all bothered", "a little bit bothered" , "moderately bothered", "very bothered", "extremely bothered"
Measured: Baseline, 6 weeks
Change in penetrative sexual intercourse
Measured using self-reported question: "Over the past 4 weeks: When you attempted intercourse, how often were you able to penetrate (enter) your partner?" Responses include "no sexual activity", "almost never or never" , "a few times (less than half the time)", "sometimes (about half the time)", "Most times (more than half the time)", "almost always or always.
Measured: Baseline, 6 weeks
Surgical straightening intervention
Number of subjects to require surgical straightening
Measured: 6 weeks
Change in erectile function
Measured using the International Index of erectile Function
Measured: Baseline, 6 weeks
Change in Erectile Function Domain (IIEF-EF)
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start19 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065436
- Sponsor's protocol ID
- 23-002478
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2023
- Last updated
- 16 Oct 2026
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06065436
- Acronym / sponsor ID
- 23-002478
- Conditions
- Peyronie Disease, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Oct 2023 (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 whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy | Experimental | Drug: Collagenase Clostridium Histolyticum, Device: Storz Duolith LiSWTSubjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT). |
| Collagenase Clostridium Histolyticum | Active comparator | Drug: Collagenase Clostridium HistolyticumSubjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with PD
- Palpable penile plaque
- Dorsal, lateral, or dorsolateral penile curvature
- Penile curvature > 30 degrees and < 90 degrees as measured using goniometer during objective curvature assessment
- Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
Key exclusion criteria (7 listed)
- 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.
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: XiaflexTotal of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart. | Drug | Collagenase Clostridium Histolyticum, Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy |
| Storz Duolith LiSWTSingle low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks/minute and using a power setting of 0.09 mJ/mm2. These treatments will occur four separate times, before each of the four separate CCH injection series. | Device | Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy |
Primary outcome
Change in symptom bother
Time frame: Baseline, 6 weeks
Measured using the validated Peyronie's Disease Questionnaire (PDQ) subdomain symptom bother. Four questions to evaluate pain or discomfort during vaginal intercourse: responses include "not at all bothered", "a little bit bothered" , "moderately bothered", "very bothered", "extremely bothered"
Change in penetrative sexual intercourse
Time frame: Baseline, 6 weeks
Measured using self-reported question: "Over the past 4 weeks: When you attempted intercourse, how often were you able to penetrate (enter) your partner?" Responses include "no sexual activity", "almost never or never" , "a few times (less than half the time)", "sometimes (about half the time)", "Most times (more than half the time)", "almost always or always.
Surgical straightening intervention
Time frame: 6 weeks
Number of subjects to require surgical straightening
Change in erectile function
Time frame: Baseline, 6 weeks
Measured using the International Index of erectile Function
Change in Erectile Function Domain (IIEF-EF)
Time frame: Baseline, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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.
Tobias Kohler, MD 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 Storz Duolith LiSWT in people with Peyronie Disease and Erectile Dysfunction, 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carter Day (507-422-5076, Day.Carter@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom bother (time frame: Baseline, 6 weeks). The study lists 5 primary outcomes in all. 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 16 Oct 2026.