Trial Outcomes & Findings for Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED) (NCT NCT00731666)

NCT ID: NCT00731666

Last Updated: 2013-11-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2013-11-28

Participant Flow

Participant milestones

Measure	Titan® IPP Subjects implanted with Titan® IPP
Overall Study STARTED	40
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Titan® IPP Subjects implanted with Titan® IPP
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Titan® IPP n=40 Participants Subjects implanted with Titan® IPP
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Age Continuous	66.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Titan® IPP n=31 Participants Subjects implanted with Titan® IPP
The Study's Primary Objective Will Assess the Change in Penile Length. Pubic bone to meatus - erect	1.14 cm Standard Deviation 1.94
The Study's Primary Objective Will Assess the Change in Penile Length. Pubic bone to meatus - flaccid	0.99 cm Standard Deviation 1.64
The Study's Primary Objective Will Assess the Change in Penile Length. Pubic bone to meatus - stretched	1.04 cm Standard Deviation 1.94
The Study's Primary Objective Will Assess the Change in Penile Length. Pubic bone to proximal end of corona - erect	0.94 cm Standard Deviation 1.41
The Study's Primary Objective Will Assess the Change in Penile Length. Pubic bone to proximal end of corona - flaccid	0.69 cm Standard Deviation 1.69
The Study's Primary Objective Will Assess the Change in Penile Length. Pubic bone to proximal end of corona - stretched	0.59 cm Standard Deviation 1.59
The Study's Primary Objective Will Assess the Change in Penile Length. Pubopenile skin junction to meatus - erect	0.93 cm Standard Deviation 1.41
The Study's Primary Objective Will Assess the Change in Penile Length. Pubopenile skin junction to meatus - flaccid	0.71 cm Standard Deviation 1.48
The Study's Primary Objective Will Assess the Change in Penile Length. Pubopenile skin junction to meatus - stretched	0.95 cm Standard Deviation 1.98
The Study's Primary Objective Will Assess the Change in Penile Length. Pubopenile skin junct to prox end of corona-erect	0.93 cm Standard Deviation 1.5
The Study's Primary Objective Will Assess the Change in Penile Length. Pubopenile skin junct to prox end of corona-flacci	0.75 cm Standard Deviation 1.58
The Study's Primary Objective Will Assess the Change in Penile Length. Pubopenile skin junct to prox end of corona-stretc	0.64 cm Standard Deviation 2.00

SECONDARY outcome

Timeframe: 12 and 24 months

Population: Subjects implanted with Titan IPP

Outcome measures

Measure	Titan® IPP n=31 Participants Subjects implanted with Titan® IPP
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 12 mo: Over past 4 wks, completely satisfied	48.4 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 12 mo: Over past 4 wks, mostly satisfied	16.1 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 12 mo: Over past 4 weeks, somewhat dissatisfied	22.6 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 12 mo: Over past 4 wks, completely dissatisfied	12.9 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 24 mo: Over past 4 wks, completely satisfied	57.1 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 24 mo: Over past 4 wks, mostly satisfied	10.7 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 24 mo: Neutral	3.6 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 24 mo: Over past 4 weeks, somewhat dissatisfied	7.1 percentage of participants
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. At 24 mo: Over past 4 weeks, completely dissatisfi	21.4 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Subject responses to 3 questions were evaluated:

1. On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?

2. Overall, how often have you needed to change your daily activities because of urinary incontinence?

3. Overall, how big of a social problem has urinary incontinence been for you during the past month?

Outcome measures

Measure	Titan® IPP n=31 Participants Subjects implanted with Titan® IPP
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 1: Improved	16.7 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 1: Unchanged (Satisfactory)	66.7 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 1: Worsened	16.7 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 2: Improved	12.9 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 2: Unchanged (Satisfactory)	61.3 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 2: Worsened	25.8 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 3: Improved	19.4 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 3: Unchanged (Satisfactory)	67.7 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 3: Unchanged (Unsatisfactory)	3.2 percentage of participants
The Rate of Change in Male Stress Urinary Incontinence(SUI). Question 3: Worsened	9.7 percentage of participants

Adverse Events

Titan® IPP

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Titan® IPP n=40 participants at risk Subjects implanted with Titan® IPP
Surgical and medical procedures Infection	2.5% 1/40 • Number of events 1 • Adverse events were collected for 24 months.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Manager

Coloplast Corp

Phone: 612-302-4990

Email: usdibe@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place