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Completed

NCT Number: NCT00731939

Titan® One Touch Release Inflatable Penile Prosthesis

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.

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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

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St Joseph's Hospital, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant has an estimated life expectancy of more than 5 years
  • Participant has been diagnosed with erectile dysfunction (impotence)
  • participant is willing to have the Titan OTR IPP implanted
  • Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol

Exclusion criteria

  • Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
  • Participant had a previous penile prosthesis or prior penile enlargement surgeries
  • Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
  • Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
  • Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability
  • Participant does not have the manual dexterity or mental ability to operate the pump
  • Participant has chordee or priapism
  • Participant has penile sensory neuropathy
  • Participant has serious bleeding disorder

Treatment and study plan

Inflatable Penile Prosthesis

Device

Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.

Other names: Titan®, Titan® OTR

Primary outcomes

  1. Assess the Ease of Deflation of the Titan® OTR Pump

    Time frame: 6 months

    The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of "satisfactory" or "somewhat satisfactory". Other possible responses were "neither satisfactory nor unsatisfactory", "somewhat unsatisfactory", and "very unsatisfactory".

Secondary outcomes

  1. Evaluate User Acceptance of Titan® OTR - Question 1

    Time frame: 3 months post-surgery

    Subject Satisfaction - overall function

  2. Evaluate User Acceptance of Titan® OTR - Question 1

    Time frame: 6 months post-surgery

    Subject Satisfaction - overall function

  3. Evaluate User Acceptance of Titan® OTR - Question 1

    Time frame: 12 months post-surgery

    Subject Satisfaction - overall function

  4. Evaluate User Acceptance of Titan® OTR - Question 2

    Time frame: 3 months post-surgery

    Subject Satisfaction - soft enough to conceal when deflated

  5. Evaluate User Acceptance of Titan® OTR - Question 2

    Time frame: 6 months post-surgery

    Subject Satisfaction - soft enough to conceal when deflated

  6. Evaluate User Acceptance of Titan® OTR - Question 2

    Time frame: 12 months post-surgery

    Subject Satisfaction - soft enough to conceal when deflated

  7. Evaluate User Acceptance of Titan® OTR - Question 3

    Time frame: 3 months post-surgery

    Subject Satisfaction - ease of locating the deflation touch pads

  8. Evaluate User Acceptance of Titan® OTR - Question 3

    Time frame: 6 months post-surgery

    Subject Satisfaction - ease of locating the deflation touch pads

  9. Evaluate User Acceptance of Titan® OTR - Question 3

    Time frame: 12 months post-surgery

    Subject Satisfaction - ease of locating the deflation touch pads

  10. Evaluate User Acceptance of Titan® OTR - Question 4

    Time frame: 3 months post-surgery

    Subject Satisfaction - ease of inflation

  11. Evaluate User Acceptance of Titan® OTR - Question 4

    Time frame: 6 months post-surgery

    Subject Satisfaction - ease of inflation

  12. Evaluate User Acceptance of Titan® OTR - Question 4

    Time frame: 12 months post-surgery

    Subject Satisfaction - ease of inflation

  13. Evaluate User Acceptance of Titan® OTR - Question 5

    Time frame: 3 months post-surgery

    Subject Satisfaction - ease of deflation

  14. Evaluate User Acceptance of Titan® OTR - Question 5

    Time frame: 6 months post-surgery

    Subject Satisfaction - ease of deflation

  15. Evaluate User Acceptance of Titan® OTR - Question 5

    Time frame: 12 months post-surgery

    Subject Satisfaction - ease of deflation

  16. Evaluate User Acceptance of Titan® OTR - Question 6

    Time frame: 3 months post-surgery

    Subject Satisfaction - hardness of erection when inflated

  17. Evaluate User Acceptance of Titan® OTR - Question 6

    Time frame: 6 months post-surgery

    Subject Satisfaction - hardness of erection when inflated

  18. Evaluate User Acceptance of Titan® OTR - Question 6

    Time frame: 12 months post-surgery

    Subject Satisfaction - hardness of erection when inflated

  19. Evaluate User Acceptance of Titan® OTR - Question 7

    Time frame: 3 months post-surgery

    Subject Satisfaction - width when inflated

  20. Evaluate User Acceptance of Titan® OTR - Question 7

    Time frame: 6 months post-surgery

    Subject Satisfaction - width when inflated

  21. Evaluate User Acceptance of Titan® OTR - Question 7

    Time frame: 12 months post-surgery

    Subject Satisfaction - width when inflated

  22. Evaluate User Acceptance of Titan® OTR - Question 8

    Time frame: 3 months post-surgery

    Subject Satisfaction - length when inflated

  23. Evaluate User Acceptance of Titan® OTR - Question 8

    Time frame: 6 months post-surgery

    Subject Satisfaction - length when inflated

  24. Evaluate User Acceptance of Titan® OTR - Question 8

    Time frame: 12 months post-surgery

    Subject Satisfaction - length when inflated

  25. Evaluate User Acceptance of Titan® OTR - Question 9

    Time frame: 3 months post-surgery

    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?

  26. Evaluate User Acceptance of Titan® OTR - Question 9

    Time frame: 6 months post-surgery

    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?

  27. Evaluate User Acceptance of Titan® OTR - Question 9

    Time frame: 12 months post-surgery

    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?

  28. Evaluate User Acceptance of Titan® OTR - Question 10

    Time frame: 3 months post-surgery

    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?

  29. Evaluate User Acceptance of Titan® OTR - Question 10

    Time frame: 6 months post-surgery

    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?

  30. Evaluate User Acceptance of Titan® OTR - Question 10

    Time frame: 12 months post-surgery

    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?

  31. Assess the Ease of Implant of the Titan® OTR Question 1

    Time frame: At implant

    Titan OTR pre-implant product preparation was straightforward/simple?

  32. Assess the Ease of Implant of the Titan® OTR - Question 2

    Time frame: At implant

    Titan OTR pre-implant product preparation was easier than your usual pump of choice?

  33. Assess the Ease of Implant of the Titan® OTR - Question 3

    Time frame: At implant

    The subject was easily able to accommodate the OTR pump?

  34. Assess the Ease of Training for Titan® OTR - Question 1

    Time frame: 6 weeks

    It was easy for the subject to find the inflation bulb?

  35. Assess the Ease of Training for Titan® OTR - Question 2

    Time frame: 6 weeks

    It was easy for the subject to find the deflation touch pads?

  36. Assess the Ease of Training for Titan® OTR - Question 3

    Time frame: 6 weeks

    It was easy for the subject to inflate the device?

  37. Assess the Ease of Training for Titan® OTR - Question 4

    Time frame: 6 weeks

    It was easy for the subject to compress the deflation touch pads?

  38. Assess the Ease of Training for Titan® OTR - Question 5

    Time frame: 6 weeks

    Subject training with OTR pump was easier than with previous pump?

  39. Assess the Ease of Training for Titan® OTR - Question 6

    Time frame: 6 weeks

    The OTR pump was easy to use at 1st cycling?

  40. Assess the Ease of Training for Titan® OTR - Question 7

    Time frame: 6 weeks

    The subject likes the OTR pump?

  41. Assess the Ease of Training for Titan® OTR - Question 8

    Time frame: 6 weeks

    How easy was it for the subject to learn?

  42. Assess the Ease of Training for Titan® OTR - Question 9

    Time frame: 6 weeks

    How likely the subject will need continued training or retraining?

  43. Assess Partner Satisfaction (Where Applicable)

    Time frame: Baseline

    The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.

  44. Assess Partner Satisfaction (Where Applicable)

    Time frame: 6 months

    The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 11, 2008
Registry last updated
Apr 14, 2014

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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