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

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00731666
• Collaborator: (none)
• Enrollment: 40
• Locations: 3
• Arm: 1
• Duration (Months): 41
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Device: Inflatable Penile Prosthesis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2007
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Titan® IPP Subjects implanted with Titan® IPP	Device: Inflatable Penile Prosthesis; 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.; Other Names: Titan

Outcome Measures

Primary Outcome Measures

1. The Study's Primary Objective Will Assess the Change in Penile Length. [12 months]

Secondary Outcome Measures

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

2. The Rate of Change in Male Stress Urinary Incontinence(SUI). [12 months]

   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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James A Haley VA	Tampa	Florida	United States	33612
2	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
3	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Gerard Henry, MD, Regional Urology, LLC
• Principal Investigator: Rafael Carrion, MD, JAames A Haley VA
• Principal Investigator: Run Wang, MD, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT00731666
• Other Study ID Numbers: US001SU
• First Posted: Aug 11, 2008
• Last Update Posted: Nov 28, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Coloplast A/S: penile length; IPP; Erectile dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

Participant Flow

Arm/Group Title	Titan® IPP
Arm/Group Description	Subjects implanted with Titan® IPP
Period Title: Overall Study
STARTED	40
COMPLETED	28
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Titan® IPP
Arm/Group Description	Subjects implanted with Titan® IPP
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 42.5%
>=65 years	23 57.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.2 (11.4)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	40 100%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	The Study's Primary Objective Will Assess the Change in Penile Length.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® IPP
Arm/Group Description	Subjects implanted with Titan® IPP
Measure Participants	31
Pubic bone to meatus - erect	1.14 (1.94)
Pubic bone to meatus - flaccid	0.99 (1.64)
Pubic bone to meatus - stretched	1.04 (1.94)
Pubic bone to proximal end of corona - erect	0.94 (1.41)
Pubic bone to proximal end of corona - flaccid	0.69 (1.69)
Pubic bone to proximal end of corona - stretched	0.59 (1.59)
Pubopenile skin junction to meatus - erect	0.93 (1.41)
Pubopenile skin junction to meatus - flaccid	0.71 (1.48)
Pubopenile skin junction to meatus - stretched	0.95 (1.98)
Pubopenile skin junct to prox end of corona-erect	0.93 (1.5)
Pubopenile skin junct to prox end of corona-flacci	0.75 (1.58)
Pubopenile skin junct to prox end of corona-stretc	0.64 (2.00)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects implanted with Titan IPP

Arm/Group Title	Titan® IPP
Arm/Group Description	Subjects implanted with Titan® IPP
Measure Participants	31
At 12 mo: Over past 4 wks, completely satisfied	48.4 121%
At 12 mo: Over past 4 wks, mostly satisfied	16.1 40.3%
At 12 mo: Over past 4 weeks, somewhat dissatisfied	22.6 56.5%
At 12 mo: Over past 4 wks, completely dissatisfied	12.9 32.3%
At 24 mo: Over past 4 wks, completely satisfied	57.1 142.8%
At 24 mo: Over past 4 wks, mostly satisfied	10.7 26.8%
At 24 mo: Neutral	3.6 9%
At 24 mo: Over past 4 weeks, somewhat dissatisfied	7.1 17.8%
At 24 mo: Over past 4 weeks, completely dissatisfi	21.4 53.5%

3. Secondary Outcome

Title	The Rate of Change in Male Stress Urinary Incontinence(SUI).
Description	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?
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® IPP
Arm/Group Description	Subjects implanted with Titan® IPP
Measure Participants	31
Question 1: Improved	16.7 41.8%
Question 1: Unchanged (Satisfactory)	66.7 166.8%
Question 1: Worsened	16.7 41.8%
Question 2: Improved	12.9 32.3%
Question 2: Unchanged (Satisfactory)	61.3 153.3%
Question 2: Worsened	25.8 64.5%
Question 3: Improved	19.4 48.5%
Question 3: Unchanged (Satisfactory)	67.7 169.3%
Question 3: Unchanged (Unsatisfactory)	3.2 8%
Question 3: Worsened	9.7 24.3%

Adverse Events

Time Frame	Adverse events were collected for 24 months.
Arm/Group Title	Titan® IPP
Arm/Group Description	Subjects implanted with Titan® IPP
All Cause Mortality
	Titan® IPP
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Titan® IPP
	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)
Surgical and medical procedures
Infection	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Titan® IPP
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.