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

Coloplast

Status

Completed

Conditions

Erectile Dysfunction

Treatments

Device: Inflatable Penile Prosthesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00731666

US001SU

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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