Health Condition 1: N489- Disorder of penis, unspecified
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sexually active men age >=18 years, 2. International Index of erectile Function (IIEF-15 > 16) 3. Stable PD (penile deformity unchanged for 6 months), months associated with a soft nodule or plaque and/or painful erection and/or a recent change in penile curvature. 4. Presence of a palpable plaque, and has a single axis penile curvature (less than 90 degrees) 5. Ultrasound to confirm the presence of a penile plaque
Exclusion criteria
Exclusion criteria: 1. Presence of hinge or lateral indentation or hour-glass deformity, 2. Patients at the chronic or fibrotic stage of PD 3. Previous medical, surgical and EWST treatment for PD 4. Calcified plaques or hourglass deformity as defined at duplex Doppler ultrasonography 5. Significant concomitant Erectile Dysfunction (IIEF-15 score 6. Any medical treatment for ED before or during the study 7. Severe penile curvature incompatible with sexual intercourse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Penile curvature (degree).Timepoint: Baseline After 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of plaque size (mm), measured by ultrasound. 2. International Index of Erectile function questionnaire (IIEF-5) score Timepoint: Baseline After 12 weeks | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Bhopal