Erectile Dysfunction
Conditions
Keywords
penile length, IPP, Erectile dysfunction
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.
Interventions
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.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Study's Primary Objective Will Assess the Change in Penile Length. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Titan® IPP Subjects implanted with Titan® IPP | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Titan® IPP |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age Continuous | 66.2 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 1 / 40 |
Outcome results
Primary
The Study's Primary Objective Will Assess the Change in Penile Length.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Titan® IPP | The Study's Primary Objective Will Assess the Change in Penile Length. | Pubic bone to meatus - flaccid | 0.99 cm | Standard Deviation 1.64 |
| Titan® IPP | The Study's Primary Objective Will Assess the Change in Penile Length. | Pubic bone to meatus - stretched | 1.04 cm | Standard Deviation 1.94 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
Secondary
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.
Time frame: 12 and 24 months
Population: Subjects implanted with Titan IPP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® IPP | 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 |
| 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 |
| 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, mostly satisfied | 16.1 percentage of participants |
| 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 weeks, somewhat dissatisfied | 22.6 percentage of participants |
| 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 dissatisfied | 12.9 percentage of participants |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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 |
| Titan® IPP | 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
The Rate of Change in Male Stress Urinary Incontinence(SUI).
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 1: Improved | 16.7 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 1: Unchanged (Satisfactory) | 66.7 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 1: Worsened | 16.7 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 2: Improved | 12.9 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 2: Unchanged (Satisfactory) | 61.3 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 2: Worsened | 25.8 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 3: Improved | 19.4 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 3: Unchanged (Satisfactory) | 67.7 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 3: Unchanged (Unsatisfactory) | 3.2 percentage of participants |
| Titan® IPP | The Rate of Change in Male Stress Urinary Incontinence(SUI). | Question 3: Worsened | 9.7 percentage of participants |