Erectile Dysfunction
Conditions
Brief summary
This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.
Detailed description
Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously. Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers several potential advantages in that it is minimally-invasive, does not increase the morbidity of surgery, and has not been shown to result in any long-term side effects. A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and limited amount of data available, we sought to perform a clinical trial evaluating the effect of PTT on increasing the total length of prosthesis which can be inserted. We additionally sought to determine if PTT resulted in improved post-operative satisfaction on total penile length achieved. To accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to publish in a scientific journal.
Interventions
DEVICERestoreX
Penile traction therapy in the straight position
OTHERControl
No treatment
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men undergoing placement of a penile prosthesis * Must be the first time a penile prosthesis is implanted * Undergoing implantation of a 3-piece inflatable penile prosthesis
Exclusion criteria
* Prior ischemic priapism * Any prior penile prosthesis surgeries * Any prior penile surgeries other than circumcision * Undergoing malleable penile prosthesis or Ambicor device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length Assessment of Penile Prosthesis Implanted | From baseline to 3 months | The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Traction | From baseline to 3 months | Compare patient reported satisfaction with use of traction device |
| Adverse Events With Use of Traction | From baseline to 3 months | Evaluate any adverse events with use of RestoreX® for penile lengthening. |
| Participant Compliance | From baseline to 3 months | Compare Participant compliance with traction device |
| Stretched Penile Length | From baseline to 12 months | Compare pre- and post-operative stretched penile lengths |
| Participant Satisfaction Penile Length | Baseline to 12 months post-operative | Compare participant satisfaction scores including satisfaction with overall penile length |
| Operative Complications | 3, 6, 12 months post-operative | Compare intra- and/or post-operative complication rates. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Control No treatment will be administered and men will not have to delay their IPP procedure
Control: No treatment | 4 |
| Group 2 - PTT 3x Daily x 3 Months Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP
RestoreX: Penile traction therapy in the straight position | 20 |
| Total | 24 |
Baseline characteristics
| Characteristic | Group 2 - PTT 3x Daily x 3 Months | Total | Group 1 - Control |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 9.1 | 63.8 years STANDARD_DEVIATION 9 | 64.5 years STANDARD_DEVIATION 8.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 24 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 24 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 20 |
| other Total, other adverse events | 0 / 4 | 0 / 20 |
| serious Total, serious adverse events | 0 / 4 | 0 / 20 |
Outcome results
Primary
Length Assessment of Penile Prosthesis Implanted
The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)
Time frame: From baseline to 3 months
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
Secondary
Adverse Events With Use of Traction
Evaluate any adverse events with use of RestoreX® for penile lengthening.
Time frame: From baseline to 3 months
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
Secondary
Operative Complications
Compare intra- and/or post-operative complication rates.
Time frame: 3, 6, 12 months post-operative
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
Secondary
Participant Compliance
Compare Participant compliance with traction device
Time frame: From baseline to 3 months
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
Secondary
Participant Satisfaction Penile Length
Compare participant satisfaction scores including satisfaction with overall penile length
Time frame: Baseline to 12 months post-operative
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
Secondary
Participant Satisfaction With Traction
Compare patient reported satisfaction with use of traction device
Time frame: From baseline to 3 months
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
Secondary
Stretched Penile Length
Compare pre- and post-operative stretched penile lengths
Time frame: From baseline to 12 months
Population: Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.