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Titan® One Touch Release Inflatable Penile Prosthesis

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Inflatable Penile Prosthesis
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Penile implant, Titan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Healthcare
  • Rush Presbyterian
  • Boston Medical Center
  • Michigan Urology Center
  • Carolina Urologic Research Center
  • Urology San Antonio
  • St Joseph's Hospital
  • University College London Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Titan® OTR IPP

Arm Description

Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
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?
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?
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?
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?
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?
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?
Assess the Ease of Implant of the Titan® OTR Question 1
Titan OTR pre-implant product preparation was straightforward/simple?
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?
Assess the Ease of Implant of the Titan® OTR - Question 3
The subject was easily able to accommodate the OTR pump?
Assess the Ease of Training for Titan® OTR - Question 1
It was easy for the subject to find the inflation bulb?
Assess the Ease of Training for Titan® OTR - Question 2
It was easy for the subject to find the deflation touch pads?
Assess the Ease of Training for Titan® OTR - Question 3
It was easy for the subject to inflate the device?
Assess the Ease of Training for Titan® OTR - Question 4
It was easy for the subject to compress the deflation touch pads?
Assess the Ease of Training for Titan® OTR - Question 5
Subject training with OTR pump was easier than with previous pump?
Assess the Ease of Training for Titan® OTR - Question 6
The OTR pump was easy to use at 1st cycling?
Assess the Ease of Training for Titan® OTR - Question 7
The subject likes the OTR pump?
Assess the Ease of Training for Titan® OTR - Question 8
How easy was it for the subject to learn?
Assess the Ease of Training for Titan® OTR - Question 9
How likely the subject will need continued training or retraining?
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.
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.

Full Information

First Posted
August 7, 2008
Last Updated
March 7, 2014
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00731939
Brief Title
Titan® One Touch Release Inflatable Penile Prosthesis
Official Title
Titan® One Touch Release Inflatable Penile Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, Penile implant, Titan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Titan® OTR IPP
Arm Type
Other
Arm Description
Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Intervention Type
Device
Intervention Name(s)
Inflatable Penile Prosthesis
Other Intervention Name(s)
Titan®, Titan® OTR
Intervention Description
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
Primary Outcome Measure Information:
Title
Assess the Ease of Deflation of the Titan® OTR Pump
Description
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".
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluate User Acceptance of Titan® OTR - Question 1
Description
Subject Satisfaction - overall function
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 1
Description
Subject Satisfaction - overall function
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 1
Description
Subject Satisfaction - overall function
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 2
Description
Subject Satisfaction - soft enough to conceal when deflated
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 2
Description
Subject Satisfaction - soft enough to conceal when deflated
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 2
Description
Subject Satisfaction - soft enough to conceal when deflated
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 3
Description
Subject Satisfaction - ease of locating the deflation touch pads
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 3
Description
Subject Satisfaction - ease of locating the deflation touch pads
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 3
Description
Subject Satisfaction - ease of locating the deflation touch pads
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 4
Description
Subject Satisfaction - ease of inflation
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 4
Description
Subject Satisfaction - ease of inflation
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 4
Description
Subject Satisfaction - ease of inflation
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 5
Description
Subject Satisfaction - ease of deflation
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 5
Description
Subject Satisfaction - ease of deflation
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 5
Description
Subject Satisfaction - ease of deflation
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 6
Description
Subject Satisfaction - hardness of erection when inflated
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 6
Description
Subject Satisfaction - hardness of erection when inflated
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 6
Description
Subject Satisfaction - hardness of erection when inflated
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 7
Description
Subject Satisfaction - width when inflated
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 7
Description
Subject Satisfaction - width when inflated
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 7
Description
Subject Satisfaction - width when inflated
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 8
Description
Subject Satisfaction - length when inflated
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 8
Description
Subject Satisfaction - length when inflated
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 8
Description
Subject Satisfaction - length when inflated
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 9
Description
Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 9
Description
Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 9
Description
Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Time Frame
12 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 10
Description
Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Time Frame
3 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 10
Description
Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Time Frame
6 months post-surgery
Title
Evaluate User Acceptance of Titan® OTR - Question 10
Description
Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Time Frame
12 months post-surgery
Title
Assess the Ease of Implant of the Titan® OTR Question 1
Description
Titan OTR pre-implant product preparation was straightforward/simple?
Time Frame
At implant
Title
Assess the Ease of Implant of the Titan® OTR - Question 2
Description
Titan OTR pre-implant product preparation was easier than your usual pump of choice?
Time Frame
At implant
Title
Assess the Ease of Implant of the Titan® OTR - Question 3
Description
The subject was easily able to accommodate the OTR pump?
Time Frame
At implant
Title
Assess the Ease of Training for Titan® OTR - Question 1
Description
It was easy for the subject to find the inflation bulb?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 2
Description
It was easy for the subject to find the deflation touch pads?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 3
Description
It was easy for the subject to inflate the device?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 4
Description
It was easy for the subject to compress the deflation touch pads?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 5
Description
Subject training with OTR pump was easier than with previous pump?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 6
Description
The OTR pump was easy to use at 1st cycling?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 7
Description
The subject likes the OTR pump?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 8
Description
How easy was it for the subject to learn?
Time Frame
6 weeks
Title
Assess the Ease of Training for Titan® OTR - Question 9
Description
How likely the subject will need continued training or retraining?
Time Frame
6 weeks
Title
Assess Partner Satisfaction (Where Applicable)
Description
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.
Time Frame
Baseline
Title
Assess Partner Satisfaction (Where Applicable)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Brock, MD
Organizational Affiliation
St Joseph's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo Munarriz, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Levine, MD
Organizational Affiliation
Rush Presbyterian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chad Ritenour, MD
Organizational Affiliation
Emory Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LeRoy Jones, MD
Organizational Affiliation
Urology San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Bogache, MD
Organizational Affiliation
Carolina Urologic Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Ohl, MD
Organizational Affiliation
Michigan Urology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Ralph, MD
Organizational Affiliation
University College London Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Healthcare
City
Altanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush Presbyterian
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Michigan Urology Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
St Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
University College London Hospital
City
London
State/Province
UK
ZIP/Postal Code
W1G 6BJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22759540
Citation
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 Sex Med. 2012 Sep;9(9):2467-74. doi: 10.1111/j.1743-6109.2012.02819.x. Epub 2012 Jul 3.
Results Reference
result

Learn more about this trial

Titan® One Touch Release Inflatable Penile Prosthesis

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