Peyronie's DiseasePhase 4iSCRIPNCT04786106
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
A Phase 4 study testing Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH), Penile Plication Surgery and Incision and Grafting (I&G) Surgery in people with Peyronie's Disease, run by Charitable Union for the Research and Education of Peyronie's Disease at 1 site in United States.
Trial summary
The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH), Penile Plication Surgery and Incision and Grafting (I&G) Surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 15 Feb 2027
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men with PD
- >18 years old
- Curvature ≥30 degrees
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
Who cannot join
- Prior treatment with CCH or surgery
- Moderate (shadowing) or severe (>1 cm) penile calcification
- Any contraindications to CCH, PTT, or surgery - as determined by the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
The Male Fertility and Peyronie's Clinic
Orem, Utah, 84057
About this study
Official title: Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial
The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.
Read the detailed description
After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.
- Conditions
- Peyronie's Disease
- Being tested
- Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH), Penile Plication Surgery, Incision and Grafting (I&G) Surgery, RestoreX Penile Traction Device
- Keywords
- collagenase clostridium histolyticum, RestoreX, plication, incision and grafting, surgery
- Medical subject headings
- Penile Induration, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)Drug
Also called Xiaflex
Men in this cohort would receive the full series of 8 Xiaflex injections: 2 injections separated by 1-3 days, repeated 3 additional times with 6 week breaks between treatments.
Penile Plication SurgeryProcedure or surgery
Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures <70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment.
Incision and Grafting (I&G) SurgeryProcedure or surgery
Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures <70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment.
RestoreX Penile Traction DeviceDevice
RestoreX is a Class I PTT device developed by PathRight Medical, is registered with the FDA, and has randomized controlled data demonstrating efficacy when used for the treatment of PD.
| Study group | Role | What they receive |
|---|---|---|
| CCH+PTT | Active comparator | Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit. Receives: Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH); Device: RestoreX Penile Traction Device |
| Surgery+PTT | Active comparator | Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit. Receives: Procedure: Penile Plication Surgery; Procedure: Incision and Grafting (I&G) Surgery; Device: RestoreX Penile Traction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction with treatment
Answer to SAPS question #1 (How satisfied are you with the effect of your treatment?) to determine overall satisfaction at all time points
Measured: 1 year
Subjective reporting of erectile dysfunction post treatment
Comparison of erectile dysfunction complication rates
Measured: 1 year
Subjective reporting of changes in penile sensation post treatment
Comparison of changes in penile sensation complication rates
Measured: 1 year
Subjective reporting of changes in penile length post treatment
Comparison of perceived changes in penile length complication rates
Measured: 1 year
International Index of Erectile Function, Erectile Function Domain (IIEF) Scores
Comparison of IIEF erectile function domain score (Q1-5, 15; min/max 1-30; higher is better)
Measured: 1 year
Secondary outcomes (8)
Peyronie's Disease Questionnaire (PDQ) Scores
Comparison of PDQ questionnaire scores; Subdomains - psychological and physical (Q1-6; min/max 0-24; lower is better), penile pain (Q7-9; min/max 0-30; lower is better), symptom bother (Q10-15; min/max 0-16; lower is better)
Measured: 1 year
International Index of Erectile Function (IIEF) Scores
Comparison of IIEF questionnaire scores-all domains except erectile function (which is a primary endpoint); subdomains: orgasmic function (Q9-10; min/max 0-10; higher is better), sexual desire (Q11-12; min/max 2-10; higher is better), intercourse satisfaction (Q6-8; min/max 0-15; higher is better), overall satisfaction (Q13-14; min/max 2-10; higher is better)
Measured: 1 year
Beck's Depression Inventory (BDI) Scores
Comparison of BDI questionnaire scores on depression. 21 items (min/max 0-63, lower is better)
Measured: 1 year
Penile Curvature
Comparison of changes in penile curvature
Measured: 1 year
Objective measurements of penile length post treatment (compared to pre-treatment)
Comparison of changes in penile length
Measured: 1 year
Interventions required
Comparison of subsequent interventions required - surgery or CCH injections
Measured: 1 year
Hospitalizations
Number of hospitalizations or ER visits resulting from treatment
Measured: 1 year
Non-standardized questionnaire
Comparison of non-standardized questionnaire responses
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Dec 2020
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charitable Union for the Research and Education of Peyronie's Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786106
- Sponsor's protocol ID
- CUREPD101
- Acronym
- iSCRIP
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04786106
- Acronym / sponsor ID
- iSCRIP / CUREPD101
- Conditions
- Peyronie's Disease
- Keywords
- collagenase clostridium histolyticum, RestoreX, plication, incision and grafting, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charitable Union for the Research and Education of Peyronie's DiseaseUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 8 Mar 2021 (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 study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.
Detailed description
After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCH+PTT | Active comparator | Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH), Device: RestoreX Penile Traction DeviceMen will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit. |
| Surgery+PTT | Active comparator | Procedure: Penile Plication Surgery, Procedure: Incision and Grafting (I&G) Surgery, Device: RestoreX Penile Traction DeviceMen will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men with PD
- >18 years old
- Curvature ≥30 degrees
- Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
Key exclusion criteria (3 listed)
- Prior treatment with CCH or surgery
- Moderate (shadowing) or severe (>1 cm) penile calcification
- Any contraindications to CCH, PTT, or surgery - as determined by the PI
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 Histolyticum 0.9 MG [Xiaflex] (CCH)Also: XiaflexMen in this cohort would receive the full series of 8 Xiaflex injections: 2 injections separated by 1-3 days, repeated 3 additional times with 6 week breaks between treatments. | Drug | CCH+PTT |
| Penile Plication SurgeryMen in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures <70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment. | Procedure or surgery | Surgery+PTT |
| Incision and Grafting (I&G) SurgeryMen in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures <70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment. | Procedure or surgery | Surgery+PTT |
| RestoreX Penile Traction DeviceRestoreX is a Class I PTT device developed by PathRight Medical, is registered with the FDA, and has randomized controlled data demonstrating efficacy when used for the treatment of PD. | Device | CCH+PTT, Surgery+PTT |
Primary outcome
Overall satisfaction with treatment
Time frame: 1 year
Answer to SAPS question #1 (How satisfied are you with the effect of your treatment?) to determine overall satisfaction at all time points
Subjective reporting of erectile dysfunction post treatment
Time frame: 1 year
Comparison of erectile dysfunction complication rates
Subjective reporting of changes in penile sensation post treatment
Time frame: 1 year
Comparison of changes in penile sensation complication rates
Subjective reporting of changes in penile length post treatment
Time frame: 1 year
Comparison of perceived changes in penile length complication rates
International Index of Erectile Function, Erectile Function Domain (IIEF) Scores
Time frame: 1 year
Comparison of IIEF erectile function domain score (Q1-5, 15; min/max 1-30; higher is better)
8 secondary outcomes
Peyronie's Disease Questionnaire (PDQ) Scores
Time frame: 1 year
International Index of Erectile Function (IIEF) Scores
Time frame: 1 year
Beck's Depression Inventory (BDI) Scores
Time frame: 1 year
Penile Curvature
Time frame: 1 year
Objective measurements of penile length post treatment (compared to pre-treatment)
Time frame: 1 year
Interventions required
Time frame: 1 year
Hospitalizations
Time frame: 1 year
Non-standardized questionnaire
Time frame: 1 year
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 26 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH), Penile Plication Surgery and Incision and Grafting (I&G) Surgery in people with Peyronie's Disease, run by Charitable Union for the Research and Education of Peyronie's Disease 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Overall satisfaction with treatment (time frame: 1 year). 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 26 Aug 2026.