Health Condition 1: N52- Male erectile dysfunction
Conditions
Interventions
Intervention1: Bovine Pericardial Tissue Patch: Tisgenx’s BPT Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinf
Sponsors
Tisgenx, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with disabling penile curvature 2. Tunical plaques in patients with Peyronie’s disease 3. Willingness to participate and provide informed consent
Exclusion criteria
Exclusion criteria: 1. Patients requiring prostheses 2. Congenital penile curvature 3. Patients with constriction bands, unilateral indentations, and hourglass deformities 4. Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety: Incidence of adverse events related to the use of bovine pericardial patch, including infections, thrombosis, and allergic reactions. • Efficacy: Patency rates of the grafts assessed through clinical photos of erection at specified follow-up intervals.Timepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 months and 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Patients will be examined post-surgery by evaluating the ability to perform successful sexual intercourse, improvements in curvature, and satisfaction with treatment • Patch handling and characteristicsTimepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 months and 1 year. | — |
Countries
India
Contacts
Public ContactDr Pankaj Joshi
Urokul Hospital
Outcome results
None listed