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This study is designed to assess the effectiveness of the Coloplast TitanĀ® 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TitanĀ® IPP | Other | Subjects implanted with TitanĀ® IPP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflatable Penile Prosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Study's Primary Objective Will Assess the Change in Penile Length. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Subject responses to 3 questions were evaluated:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A Haley VA | Tampa | Florida | 33612 | United States | ||
| Regional Urology, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25872574 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TitanĀ® IPP | Subjects implanted with TitanĀ® IPP |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TitanĀ® IPP | Subjects implanted with TitanĀ® IPP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Study's Primary Objective Will Assess the Change in Penile Length. | Posted | Mean | Standard Deviation | cm | 12 months |
|
|
Adverse events were collected for 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TitanĀ® IPP | Subjects implanted with TitanĀ® IPP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Surgical and medical procedures | Systematic Assessment | Procedure-related infection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Coloplast Corp | 612-302-4990 | usdibe@coloplast.com |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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|
| 12 months |
| Shreveport |
| Louisiana |
| 71106 |
| United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. | Subjects implanted with Titan IPP | Posted | Number | percentage of participants | 12 and 24 months |
|
|
|
| Secondary | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Subject responses to 3 questions were evaluated:
| Posted | Number | percentage of participants | 12 months |
|
|
|
| 1 |
| 40 |
| 0 |
| 40 |
|
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
|
| At 12 mo: Over past 4 wks, completely dissatisfied |
|
| At 24 mo: Over past 4 wks, completely satisfied |
|
| At 24 mo: Over past 4 wks, mostly satisfied |
|
| At 24 mo: Neutral |
|
| At 24 mo: Over past 4 weeks, somewhat dissatisfied |
|
| At 24 mo: Over past 4 weeks, completely dissatisfi |
|
| Title | Measurements |
|---|---|
|
| Question 2: Improved |
|
| Question 2: Unchanged (Satisfactory) |
|
| Question 2: Worsened |
|
| Question 3: Improved |
|
| Question 3: Unchanged (Satisfactory) |
|
| Question 3: Unchanged (Unsatisfactory) |
|
| Question 3: Worsened |
|