Heterografts
Conditions
Interventions
This is a prospective, open-label, two-arm parallel randomized controlled clinical trial. The study will include a total of 36 participants: 18 in Group A and 18 in Group B. All participants are patie
once this occurs, subsequent participants will be automatically assigned to the group that has not yet reached 18 participants, ensuring a final composition of 18 participants per group.
The study is
the Vivendi UR graft will be used in a size equivalent to the defect created by plaque incision. Graft fixation will be performed with 4-0 Prolene, a nonabsorbable monofilament polypropylene suture, a
Sponsors
Fundação do ABC
Labcor
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients presenting with Peyronie's Disease in the chronic phase; with curvature greater than 60 degrees preferably uniplanar (patients with biplanar curvature will be accepted if secondary curvature is less than 20 degrees); without penile deformities with significant volume loss; patients must report adequate erectile function (erectile function questionnaire score greater than 22, reflecting adequate erection for vaginal penetration if penile curvature were absent); patients will undergo Penile Doppler Ultrasound with pharmacologically-induced erection to confirm normal penile hemodynamic status; heterosexual patient with sexual partner (patients with exclusive vaginal penetration); ability to complete questionnaires; able to read; be over 18 years old
Exclusion criteria
Exclusion criteria: Prior treatment for Peyronie's disease within the last three months; clinical contraindication for corrective surgery; lack of rigidity for penetration; patients undergoing treatment for malignant diseases; patients who do not sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the performance of Vivendi as a graft for corporoplasty compared to bovine pericardial graft treated with glutaraldehyde in a non-inferiority study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate patient satisfaction with Vivendi corporoplasty compared to bovine pericardial grafting treated with glutaraldehyde in a non-inferiority study.;To evaluate the correction of penile curvature and restoration of penile length in patients undergoing corporoplasty with Vivendi compared to bovine pericardial graft with glutaraldehyde treatment in a non-inferiority study.;To evaluate the incidence of complications in patients undergoing corporoplasty with Vivendi compared to bovine pericardial graft with glutaraldehyde treatment in a non-inferiority study.;To evaluate the occurrence of adverse effects in patients undergoing corporoplasty with Vivendi compared to bovine pericardial graft with glutaraldehyde treatment in a non-inferiority study.;Questionnaires: Index of Erectile Function (IIEF-5); Penile Curvature Index (ICI); Peyronie's Disease Questionnaire (PDQ); Quality of life questionnaire, related to assessing the impact of Peyronie's Disease. | — |
Countries
BR
Contacts
Public ContactLeonardo Lopes
Centro Universitário FMABC
Outcome results
None listed