Peyronie's disease
Conditions
Interventions
Experimental group 1: collagenase 150U/ml for injection:At the beginning of each treatment cycle, two injections are administered into penile plaques, with the researchers injecting 0.25ml-0.5ml/plaqu
If the patient has multiple plaques at the same time, the research doctor will determine the plaque that has the greatest impact on penile curvature, and only inject the plaque that has the greatest i
Do not engage in sexual intercourse within 4 weeks after the first treatment of each treatment cycle.
Experimental group 2: collagenase 300U/ml for injection:At the beginning of each treatment cycle, two injections are administered into penile plaques, with the researchers injecting 0.25ml-0.5ml/plaqu
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be included in this trial: 1. Male, >= 18 years old; 2. Prior to the initial administration of the investigational drug, there were symptoms or signs of Peyronie's disease, and ultrasound examination showed Peyronie's disease plaques, which are consistent with the clinical diagnosis of acute or stable Peyronie's disease; 3. At screening, the penile curvature was >=30° and <=90°, and a single plane of maximum curvature must be delineated for evaluation during the study; 4. Have the ability and willingness to complete all assessment scales; 5. Voluntarily sign and date the informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. Penile curvature less than 30° or greater than 90° at the screening visit; 2. Meet any of the following conditions; (1) Presence of hypospadias; (2) Penile arterial and/or venous thrombosis; (3) benign or malignant mass infiltration leading to curvature; (4) Infiltration of infectious agents, such as lymphogranuloma venereum; (5) Presence of active sexually transmitted diseases; (6) Known active hepatitis B or C; (7) Known immunodeficiency disease or human immunodeficiency virus (HIV) positive; (8) Severe cardiopulmonary insufficiency, severe liver and kidney insufficiency; 3. Previous surgery for Peyronie's disease; 4. The investigator judges that there is obvious calcified plaque at the injection site, and the calcified plaque affects the correct injection of the study drug; 5. Presence of hourglass penile deformity; 6. Has received extracorporeal shock wave therapy (ESWT) to correct Peyronie's disease within 6 months prior to screening, or is scheduled to have ESWT at any time during the study; 7. Use of any mechanical device to correct Peyronie's disease within 2 weeks prior to screening, or planned use of any of these devices at any time during the study; 8. Has severe erectile dysfunction that has not responded to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors; 9. Have a known recent history of stroke, bleeding, or other significant medical condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study; 10. Unwilling or unable to cooperate with the requirements of the study, including completing all planned study follow-up visits; 11. Known systemic allergy to collagenase or any other excipients; 12. Known allergy to any concomitant medications required for the protocol; 13. Received anticoagulant drugs or had a definite coagulation disorder within 7 days prior to each study drug administration; 14. Received collagenase for Peyronie's disease at any previous time; 15. Subjects do not agree to continue to take effective contraceptive measures during the study and for at least 6 months after the end of the study; 16. Patients who are judged by the investigator to be unsuitable for participating in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in penile curvature from baseline at week 24 ;Proportion of subjects who did not receive further treatment due to sufficient efficacy during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Peyronie's disease questionnaire (PDQ) scores from baseline at weeks 6, 12, 18, and 24 ;Changes in Erectile Function Index (IIEF-6) scores from baseline at weeks 6, 12, 18, and 24 ;Changes in penile curvature from baseline at weeks 6, 12, and 18 ;Changes in penis length of subjects from baseline at weeks 6, 12, 18, and 24;Changes in plaque size (length, width, diameter) from baseline at weeks 6, 12, 18, and 24;Overall treatment satisfaction of subjects at weeks 6, 12, 18, and 24; | — |
Countries
China
Contacts
Public ContactMujun Lu
Renji Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed