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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Inflatable Penile Prosthesis

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring penile length, IPP, Erectile dysfunction

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

James A Haley VA
Regional Urology, LLC
University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Titan® IPP

Arm Description

Subjects implanted with Titan® IPP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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?

Full Information

NCT ID

NCT00731666

First Posted

August 7, 2008

Last Updated

September 27, 2013

Sponsor

Coloplast A/S

1. Study Identification

Unique Protocol Identification Number

NCT00731666

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coloplast A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

penile length, IPP, Erectile dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Titan® IPP

Arm Type

Other

Arm Description

Subjects implanted with Titan® IPP

Intervention Type

Device

Intervention Name(s)

Inflatable Penile Prosthesis

Other Intervention Name(s)

Titan

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

12 and 24 months

Title

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

Description

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerard Henry, MD

Organizational Affiliation

Regional Urology, LLC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rafael Carrion, MD

Organizational Affiliation

JAames A Haley VA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Run Wang, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

James A Haley VA

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Regional Urology, LLC

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25872574

Citation

Henry GD, Carrion R, Jennermann C, Wang R. Prospective evaluation of postoperative penile rehabilitation: penile length/girth maintenance 1 year following Coloplast Titan inflatable penile prosthesis. J Sex Med. 2015 May;12(5):1298-304. doi: 10.1111/jsm.12833. Epub 2015 Apr 14.

Results Reference

derived

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

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