Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)

Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation

This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.

Inclusion Criteria:

• Has an estimated life expectancy of more than 5 years
• Has been diagnosed with erectile dysfunction
• Is willing to have the Titan IPP implanted
• Is able and willing to complete all follow-up visits and procedures indicated in this protocol
• Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site

Exclusion Criteria:

• Participant has had a previous penile prosthesis or prior penile enlargement surgeries
• Participant has a compromised immune system
• Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
• Participant does not have manual dexterity or mental ability to operate the pump
• Participant has an active urogenital infection or active skin infection in region of surgery
• Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease
• Participant is diagnosed with Chordee
• Participant has neuropathy
• Participant has a serious bleeding disorder or coagulopathy