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OpenTrials
Completed

NCT Number: NCT00731666

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

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.

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Key information

Conditions

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

Age range

25 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

James A Haley VA, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inflatable Penile Prosthesis

Device

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

Primary outcomes

  1. The Study's Primary Objective Will Assess the Change in Penile Length.

    Time frame: 12 months

Secondary outcomes

  1. Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.

    Time frame: 12 and 24 months

  2. The Rate of Change in Male Stress Urinary Incontinence(SUI).

    Time frame: 12 months

    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?

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Aug 11, 2008
Registry last updated
Nov 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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