NCT00731666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 28, 2013

Completed
Last Updated

November 28, 2013

Status Verified

September 1, 2013

Enrollment Period

2.4 years

First QC Date

August 7, 2008

Results QC Date

September 27, 2013

Last Update Submit

September 27, 2013

Conditions

Erectile Dysfunction

Keywords

penile lengthIPPErectile dysfunction

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (2)

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

    12 and 24 months

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

    12 months

Study Arms (1)

Titan® IPP

OTHER

Subjects implanted with Titan® IPP

Device: Inflatable Penile Prosthesis

Interventions

Inflatable Penile ProsthesisDEVICE

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.

Also known as: Titan
Titan® IPP

Eligibility Criteria

Age25 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

James A Haley VA

Tampa, Florida, 33612, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 25872574DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Results Point of Contact

Title
Clinical Trials Manager
Organization
Coloplast Corp
usdibe@coloplast.com
612-302-4990

Study Officials

  • Gerard Henry, MD

    Regional Urology, LLC

    PRINCIPAL INVESTIGATOR

  • Rafael Carrion, MD

    JAames A Haley VA

    PRINCIPAL INVESTIGATOR

  • Run Wang, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

December 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2011

Last Updated

November 28, 2013

Results First Posted

November 28, 2013

Record last verified: 2013-09

Locations

US(3)