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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00731666
First received: August 7, 2008
Last updated: September 27, 2013
Last verified: September 2013
History of Changes
  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
Erectile Dysfunction
 Device: Inflatable Penile Prosthesis

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • The Study's Primary Objective Will Assess the Change in Penile Length. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess Participant 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: 12 months ] [ Designated as safety issue: No ]

    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?
Enrollment: 40
Study Start Date: December 2007
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Titan

  Eligibility
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00731666     History of Changes
Other Study ID Numbers: US001SU 
Study First Received: August 7, 2008
Results First Received: September 27, 2013
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Coloplast A/S:
penile length
IPP
Erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016