Evaluation of the Coloplast Titan IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
Summary
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Erectile Dysfunction
Intervention
Inflatable Penile Prosthesis
Location
James A Haley VA
Tampa
Florida
United States
33612
Status
Active, not recruiting
Source
Coloplast A/S
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00731666
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Penile Prosthesis
Rigid, semi-rigid, or inflatable cylindric hydraulic devices, with either combined or separate reservoir and pumping systems, implanted for the surgical treatment of organic ERECTILE DYSFUNCTION.
Erectile Dysfunction
The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.
Penile Implantation
Surgical insertion of cylindric hydraulic devices for the treatment of organic ERECTILE DYSFUNCTION.
Impotence, Vasculogenic
Inability to achieve and maintain an erection (ERECTILE DYSFUNCTION) due to defects in the arterial blood flow to the PENIS, defect in venous occlusive function allowing blood drainage (leakage) from the erectile tissue (corpus cavernosum penis), or both.
Penile Induration
A condition characterized by hardening of the PENIS due to the formation of fibrous plaques on the dorsolateral aspect of the PENIS, usually involving the membrane (tunica albuginea) surrounding the erectile tissue (corpus cavernosum penis). This may eventually cause a painful deformity of the shaft or constriction of the urethra, or both.
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PubMed Articles
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