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

September 27, 2013 updated by: Coloplast A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • James A Haley VA
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Titan® IPP
Subjects implanted with Titan® IPP
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.
Other Names:
  • Titan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Study's Primary Objective Will Assess the Change in Penile Length.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.
Time Frame: 12 and 24 months
12 and 24 months
The Rate of Change in Male Stress Urinary Incontinence(SUI).
Time Frame: 12 months

Subject responses to 3 questions were evaluated:

  1. On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?
  2. Overall, how often have you needed to change your daily activities because of urinary incontinence?
  3. Overall, how big of a social problem has urinary incontinence been for you during the past month?
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US001SU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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