Health Condition 1: N51- Disorders of male genital organs in diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Males aged 18 to 65 years. Diagnosed with stable PD with disease duration more than 6 months and stable curvature for at least 3 months. Penile curvature between 30 degree and 60 degree. Adequate erectile function IIEF-5 score more than 12. Ability to provide informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Acute inflammatory phase of PD. Penile calcification or ossified plaques. Use of anticoagulants or bleeding disorders. History of prior intralesional therapy. Active genitourinary infection. Severe erectile dysfunction unresponsive to PDE5 inhibitors. Platelet count less than 100,000 per L at baseline assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Incidence of adverse events and injection tolerability. Timepoint: Baseline assessment Weekly assessments during treatment 1 month and 3 month post treatment evaluations | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: Changes in penile curvature (goniometer), plaque size (ultrasound), erectile function (IIEF-5), and pain scores (VAS). Timepoint: Baseline assessment Weekly assessments during treatment 1-month and 3-month post-treatment evaluations | — |
Countries
India
Contacts
AIIMS Raipur