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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731666
• Other study ID #: US001SU
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: September 27, 2013
• Start date: December 2007
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Inflatable Penile Prosthesis
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	James A Haley VA	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Study's Primary Objective Will Assess the Change in Penile Length.		12 months	No
Secondary	Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.		12 and 24 months	No
Secondary	The Rate of Change in Male Stress Urinary Incontinence(SUI).	Subject responses to 3 questions were evaluated: On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?; Overall, how often have you needed to change your daily activities because of urinary incontinence?; Overall, how big of a social problem has urinary incontinence been for you during the past month?	12 months	No