Evaluation of the Coloplast Titan IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED) - Full Text View

Sponsored by:	Coloplast A/S
Information provided by:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00731666

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Device: Inflatable Penile Prosthesis	Phase IV

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:

The study's primary objective will assess the participant's penile length. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the rate of satisfaction with the penile length at baseline, 12 and 24 months post implantation via participant questionaire. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
The rate of change in male stress urinary incontinence(SUI). [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
The rate of device or procedure related complications. [ Time Frame: 6 weeks and 6,12,18, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731666

Contacts

Contact: Hang Nguyen

612-287-4199

Locations

United States, Florida
James A Haley VA	Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Rafael Carrion, MD
United States, Louisiana
Regional Urology, LLC	Recruiting
Shreveport, Louisiana, United States, 71106
Principal Investigator: Gerard Henry, MD
United States, Texas
University of Texas Health Science Center at Houston	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Run Wang, MD

Sponsors and Collaborators

Coloplast A/S

Investigators

Principal Investigator:	Gerard Henry, MD	Regional Urology, LLC
Principal Investigator:	Rafael Carrion, MD	JAames A Haley VA
Principal Investigator:	Run Wang, MD	University of Texas

More Information

Responsible Party:	Coloplast ( Clinical Trial Manager Hang Nguyen )
Study ID Numbers:	US001SU
Study First Received:	August 7, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00731666
Health Authority:	United States: Institutional Review Board

Keywords provided by Coloplast A/S:

penile length
IPP
Erectile dysfunction

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009