Can a gentler injection schedule straighten the curve in Peyronie's disease?
NCT ID NCT06649539
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial tests a step-wise treatment for Peyronie's disease, a condition causing penile curvature and pain. Men receive up to four series of collagenase injections, with mild in-office modeling, plus daily use of a traction device and sildenafil. If response is inadequate, up to two additional 'salvage' injection series are offered. The study measures changes in penile curvature and length one year after treatment, and also asks sexual partners to complete questionnaires about their support.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Collagenase Clostridium Histolyticum (CCH) injections, RestoreX traction device, and sildenafil
- What this could lead to
- If successful, this step-wise approach could offer a more tolerable and effective treatment option for men with Peyronie's disease, potentially reducing curvature and preserving penile length without surgery.
- What could go wrong
- This is a small, single-arm study comparing against historical data, so results may not be definitive. Risks include injection-related pain, swelling, and rare serious complications like penile fracture or corporal rupture.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men with Peyronie's Disease * Older than 18 years old * Curvature ≥30 degrees * Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors * The patient exhibits a palpable plaque consistent with Peyronie's Disease * For partners, the only inclusion criteria is being willing to complete a questionnaire Exclusion Criteria: * Prior surgical treatment on the penis (other than circumcision) * Prior treatment with CCH injections * Any contraindications to CCH - as determined by the PI
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Male Fertility and Peyronie's Clinic
Orem, Utah, 84057, United States
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