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Injections vs. scalpel: which straightens Peyronie's curvature better?

NCT ID NCT04786106

Disease control Sponsor: Charitable Union for the Research and Education of Peyronie's Disease Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial asks whether collagenase injections (Xiaflex) or surgery is the better approach for treating Peyronie's disease, a condition that causes penile curvature and pain. About 40 men with curvature of at least 30 degrees will receive either a full course of eight Xiaflex injections or undergo penile plication or grafting surgery. Researchers will compare satisfaction, erectile function, and complications like changes in sensation or length to help guide treatment choices.

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 (Xiaflex) injections or penile plication/incision-and-grafting surgery
What this could lead to
If this trial succeeds, it could help men with Peyronie's disease choose between injection therapy and surgery based on which offers better satisfaction and fewer side effects.
What could go wrong
The trial is small (40 men) and results may not apply to everyone. Both treatments carry risks, including erectile dysfunction, changes in sensation, or penile length, and the comparison may not show a clear winner.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 PD * \>18 years old * Curvature ≥30 degrees * Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Penile Induration Peyronie disease Surgical Wound

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peyronie's disease

Contacts and locations

Locations

  • The Male Fertility and Peyronie's Clinic

    Orem, Utah, 84057, United States

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