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Trial record 11 of 494 for:    penis

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

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ClinicalTrials.gov Identifier: NCT00731666
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Intervention Device: Inflatable Penile Prosthesis
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Titan® IPP
Hide Arm/Group Description Subjects implanted with Titan® IPP
Period Title: Overall Study
Started 40
Completed 28
Not Completed 12
Reason Not Completed
Adverse Event             2
Lost to Follow-up             8
Withdrawal by Subject             2
Arm/Group Title Titan® IPP
Hide Arm/Group Description Subjects implanted with Titan® IPP
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  42.5%
>=65 years
23
  57.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
66.2  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
0
   0.0%
Male
40
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title The Study's Primary Objective Will Assess the Change in Penile Length.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® IPP
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Subjects implanted with Titan® IPP
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: cm
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.
Hide Description [Not Specified]
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects implanted with Titan IPP
Arm/Group Title Titan® IPP
Hide Arm/Group Description:
Subjects implanted with Titan® IPP
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
At 12 mo: Over past 4 wks, completely satisfied 48.4
At 12 mo: Over past 4 wks, mostly satisfied 16.1
At 12 mo: Over past 4 weeks, somewhat dissatisfied 22.6
At 12 mo: Over past 4 wks, completely dissatisfied 12.9
At 24 mo: Over past 4 wks, completely satisfied 57.1
At 24 mo: Over past 4 wks, mostly satisfied 10.7
At 24 mo: Neutral 3.6
At 24 mo: Over past 4 weeks, somewhat dissatisfied 7.1
At 24 mo: Over past 4 weeks, completely dissatisfi 21.4
3.Secondary Outcome
Title The Rate of Change in Male Stress Urinary Incontinence(SUI).
Hide Description

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?
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® IPP
Hide Arm/Group Description:
Subjects implanted with Titan® IPP
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
Question 1: Improved 16.7
Question 1: Unchanged (Satisfactory) 66.7
Question 1: Worsened 16.7
Question 2: Improved 12.9
Question 2: Unchanged (Satisfactory) 61.3
Question 2: Worsened 25.8
Question 3: Improved 19.4
Question 3: Unchanged (Satisfactory) 67.7
Question 3: Unchanged (Unsatisfactory) 3.2
Question 3: Worsened 9.7
Time Frame Adverse events were collected for 24 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Titan® IPP
Hide Arm/Group Description Subjects implanted with Titan® IPP
All-Cause Mortality
Titan® IPP
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Titan® IPP
Affected / at Risk (%) # Events
Total   1/40 (2.50%)    
Surgical and medical procedures   
Infection  [1]  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
[1]
Procedure-related infection.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Titan® IPP
Affected / at Risk (%) # Events
Total   0/40 (0.00%)    
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Manager
Organization: Coloplast Corp
Phone: 612-302-4990
EMail: usdibe@coloplast.com
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00731666     History of Changes
Other Study ID Numbers: US001SU
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: September 27, 2013
Results First Posted: November 28, 2013
Last Update Posted: November 28, 2013