Active — Not RecruitingPhase 4

Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's

United States40 participantsStarted 2020-12-30

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Overall satisfaction with treatment

Timeframe: 1 year

Subjective reporting of erectile dysfunction post treatment

Timeframe: 1 year

Subjective reporting of changes in penile sensation post treatment

Timeframe: 1 year

Subjective reporting of changes in penile length post treatment

Timeframe: 1 year

International Index of Erectile Function, Erectile Function Domain (IIEF) Scores

Timeframe: 1 year

Trial details

NCT IDNCT04786106

SponsorCharitable Union for the Research and Education of Peyronie's Disease

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-15

View on ClinicalTrials.gov More Peyronie's Disease trials