Titan® One Touch Release Inflatable Penile Prosthesis

Erectile Dysfunction Clinical Trial

Official title:

Titan® One Touch Release Inflatable Penile Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731939
• Other study ID #: DK057CC
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: March 7, 2014
• Start date: November 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Inflatable Penile Prosthesis
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.

Locations

Country	Name	City	State
Canada	St Joseph's Hospital	London	Ontario
United Kingdom	University College London Hospital	London	UK
United States	Emory Healthcare	Altanta	Georgia
United States	Michigan Urology Center	Ann Arbor	Michigan
United States	Boston Medical Center	Boston	Massachusetts
United States	Rush Presbyterian	Chicago	Illinois
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

References & Publications (1)

Ohl DA, Brock G, Ralph D, Bogache W, Jones L, Munarriz R, Levine L, Ritenour C. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast titan one touch release three-piece inflatable penile prosthesis. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Ease of Deflation of the Titan® OTR Pump	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".	6 months	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 1	Subject Satisfaction - overall function	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 1	Subject Satisfaction - overall function	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 1	Subject Satisfaction - overall function	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 2	Subject Satisfaction - soft enough to conceal when deflated	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 2	Subject Satisfaction - soft enough to conceal when deflated	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 2	Subject Satisfaction - soft enough to conceal when deflated	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 3	Subject Satisfaction - ease of locating the deflation touch pads	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 3	Subject Satisfaction - ease of locating the deflation touch pads	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 3	Subject Satisfaction - ease of locating the deflation touch pads	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 4	Subject Satisfaction - ease of inflation	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 4	Subject Satisfaction - ease of inflation	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 4	Subject Satisfaction - ease of inflation	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 5	Subject Satisfaction - ease of deflation	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 5	Subject Satisfaction - ease of deflation	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 5	Subject Satisfaction - ease of deflation	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 6	Subject Satisfaction - hardness of erection when inflated	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 6	Subject Satisfaction - hardness of erection when inflated	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 6	Subject Satisfaction - hardness of erection when inflated	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 7	Subject Satisfaction - width when inflated	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 7	Subject Satisfaction - width when inflated	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 7	Subject Satisfaction - width when inflated	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 8	Subject Satisfaction - length when inflated	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 8	Subject Satisfaction - length when inflated	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 8	Subject Satisfaction - length when inflated	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 9	Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 9	Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 9	Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?	12 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 10	Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?	3 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 10	Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?	6 months post-surgery	No
Secondary	Evaluate User Acceptance of Titan® OTR - Question 10	Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?	12 months post-surgery	No
Secondary	Assess the Ease of Implant of the Titan® OTR Question 1	Titan OTR pre-implant product preparation was straightforward/simple?	At implant	No
Secondary	Assess the Ease of Implant of the Titan® OTR - Question 2	Titan OTR pre-implant product preparation was easier than your usual pump of choice?	At implant	No
Secondary	Assess the Ease of Implant of the Titan® OTR - Question 3	The subject was easily able to accommodate the OTR pump?	At implant	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 1	It was easy for the subject to find the inflation bulb?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 2	It was easy for the subject to find the deflation touch pads?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 3	It was easy for the subject to inflate the device?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 4	It was easy for the subject to compress the deflation touch pads?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 5	Subject training with OTR pump was easier than with previous pump?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 6	The OTR pump was easy to use at 1st cycling?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 7	The subject likes the OTR pump?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 8	How easy was it for the subject to learn?	6 weeks	No
Secondary	Assess the Ease of Training for Titan® OTR - Question 9	How likely the subject will need continued training or retraining?	6 weeks	No
Secondary	Assess Partner Satisfaction (Where Applicable)	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.	Baseline	No
Secondary	Assess Partner Satisfaction (Where Applicable)	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.	6 months	No