Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysf… (NCT00731666) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
United States40 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range25 Years – 75 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The Study's Primary Objective Will Assess the Change in Penile Length.