Erectile DysfunctionNCT03500406
Penile Lengthening Pre-Penile Prosthesis Implantation
A study testing RestoreX in people with Erectile Dysfunction, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- RestoreX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior ischemic priapism
- Any prior penile prosthesis surgeries
- Any prior penile surgeries other than circumcision
- Undergoing malleable penile prosthesis or Ambicor device
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- RestoreX, Control
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestoreXDevice
Penile traction therapy in the straight position
ControlOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control | Sham comparator | No treatment will be administered and men will not have to delay their IPP procedure Receives: Other: Control |
| Group 2 - PTT 3x daily x 3 months | Experimental | Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP Receives: Device: RestoreX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From baseline to 3 months
Secondary outcomes (6)
Participant Compliance
Compare Participant compliance with traction device
Measured: From baseline to 3 months
Participant Satisfaction With Traction
Compare patient reported satisfaction with use of traction device
Measured: From baseline to 3 months
Adverse Events With Use of Traction
Evaluate any adverse events with use of RestoreX® for penile lengthening.
Measured: From baseline to 3 months
Operative Complications
Compare intra- and/or post-operative complication rates.
Measured: 3, 6, 12 months post-operative
Stretched Penile Length
Compare pre- and post-operative stretched penile lengths
Measured: From baseline to 12 months
Participant Satisfaction Penile Length
Compare participant satisfaction scores including satisfaction with overall penile length
Measured: Baseline to 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start23 Mar 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: PI changed subspecialties and no longer had access to main study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Landon W. Trost, Mayo Clinic
- Investigators
- Landon W Trost, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500406
- Sponsor's protocol ID
- 17-011052
- Status last verified
- Jan 2020
- First submitted
- 9 Apr 2018
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Lengthening Pre-Penile Prosthesis Implantation
- ClinicalTrials.gov ID
- NCT03500406
- Acronym / sponsor ID
- 17-011052
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed subspecialties and no longer had access to main study population
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Control | Sham comparator | Other: ControlNo treatment will be administered and men will not have to delay their IPP procedure |
| Group 2 - PTT 3x daily x 3 months | Experimental | Device: RestoreXMen will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Prior ischemic priapism
- Any prior penile prosthesis surgeries
- Any prior penile surgeries other than circumcision
- Undergoing malleable penile prosthesis or Ambicor device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RestoreXPenile traction therapy in the straight position | Device | Group 2 - PTT 3x daily x 3 months |
| ControlNo treatment | Other | Group 1 - Control |
Primary outcome
Length Assessment of Penile Prosthesis Implanted
Time frame: 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)
6 secondary outcomes
Participant Compliance
Time frame: From baseline to 3 months
Participant Satisfaction With Traction
Time frame: From baseline to 3 months
Adverse Events With Use of Traction
Time frame: From baseline to 3 months
Operative Complications
Time frame: 3, 6, 12 months post-operative
Stretched Penile Length
Time frame: From baseline to 12 months
Participant Satisfaction Penile Length
Time frame: Baseline to 12 months post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Landon W Trost principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RestoreX in people with Erectile Dysfunction, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length Assessment of Penile Prosthesis Implanted (time frame: From baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.