Erectile Dysfunction Following Radical ProstatectomyNCT05244486
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
A study testing RestoreX 1-6 months (randomized phase) and RestoreX 6-9 months (open label phase) in people with Erectile Dysfunction Following Radical Prostatectomy, run by Charitable Union for the Research and Education of Peyronie's Disease at 4 sites in United States.
Trial summary
Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- RestoreX 1-6 months (randomized phase) and RestoreX 6-9 months (open label phase)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Mar 2022to 14 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Undergoing bilateral nerve-sparing prostatectomy
- >18 years old
- Have a regular sexual partner for at least 6 months prior to study enrollment
Who cannot join
- Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
- Baseline severe erectile dysfunction as measured by the IIEF-EFD
- Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Sophia Kallas, BA, 312-694-0633, sophia.kallas@northwestern.edu
Nikki Hubbard, BA, 312-694-0611, nikki.hubbard@northwestern.edu
- Recruiting
University Hospital
Newark, New Jersey, 07103
Evan Kovac, MD, 973-972-7162, ek752@njms.rutgers.edu
Saharsh Patel, MS, 973-561-7047, ssp186@gsbs.rutgers.edu
- Recruiting
The Male Fertility and Peyronie's Clinic
Orem, Utah, 84057
Landon Trost, MD, (888) 655-0015, trost.landon@mfp.clinic
Holli Burgon
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Research Coordinator, 480-574-1782
About this study
Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.
Read the detailed description
Background and Preliminary Data
The treatment of prostate cancer results in several known sexual dysfunctions/risks, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Although all forms of prostate cancer treatment are associated with many of these changes, prostatectomy currently has the most data available on sexual function outcomes. Among the dysfunctions, erectile dysfunction has remained a very challenging adverse effect without effective preventative therapies. Specifically, prior randomized controlled trials evaluating the efficacy of PDE5 inhibitors (vardenafil and tadalafil) have failed to demonstrate improved erectile function preservation post-operatively.
Recently, out team conducted a single-center randomized, controlled trial evaluating the efficacy of a novel penile traction therapy (PTT) device, RestoreX at preventing penile length loss post-prostatectomy. In addition to meeting the primary outcome of achieving improved penile length compared to controls, the study unexpectedly demonstrated improvements in erectile function in the treatment group compared to controls. Results were also consistent with two other prior randomized, controlled trials, one of which demonstrated improved erectile function in men with Peyronie's Disease and the other in men with diabetes mellitus (unpublished).
As these findings represent the first known therapy which resulted in preserved erectile function post-prostatectomy, we sought to perform a larger, multi-center study in an attempt to confirm or refute findings.
Investigational Device
RestoreX is a PTT device developed by PathRight Medical using technology licensed from the Mayo Clinic. The device is classified as class I (orthotic) and does not require clinical trials to prove safety or efficacy. Mayo Clinic has previously performed 3 randomized controlled trials which have confirmed the safety of the device as well as efficacy in improving erectile function and penile length in various cohorts of men.
The device has two functional aspects. The first is the ability to provide direct traction on the penis. The second is the ability to provide counter-bending forces, to treat conditions such as Peyronie's disease (bent penis). In the current study, only the direct traction aspects of the device will be utilized.
Study Rationale
PTT with Restorex has been shown to improve erectile function in several clinical scenarios, including in men with Peyronie's disease, men with diabetes mellitus (unpublished), and post-prostatectomy. As no therapy has ever been shown to improve erectile function or prevent loss of erectile function post-prostatectomy, we felt that there was significant clinical value in performing a large, multi-center, randomized, controlled trial to affirm or refute the efficacy of Restorex PTT in preserving erectile function post-prostatectomy.
Potential Benefits
There are several anticipated benefits to using PTT following prostatectomy. As loss of penile length results in several issues including loss of sexual function, cosmetic concerns, and difficulty in maintaining hygiene (incontinence resulting in yeast infections), the ability to maintain or restore length post-prostatectomy may mitigate these issues. Our team has previously demonstrated that Restorex PTT significantly improved penile length post-prostatectomy. Although this is an anticipated beneficial effect of therapy, we will not be specifically evaluating this outcome in the current study.
In addition to improved penile length, our prior investigations have demonstrated preserved erectile function in men who received PTT with Restorex post-prostatectomy compared to controls. And among all patients in the three prior randomized, controlled trials evaluating Restorex, no significant or long-term adverse events were reported, highlighting the safety of the therapy.
Anticipated Duration of the Clinical Investigation
The overall study will be scheduled for 3 years, to permit adequate time for enrollment and follow-up. The intervention phase will include 5 months of randomized treatment (for the treatment arm), and 3 months of open label treatment (for all arms).
- Being tested
- RestoreX 1-6 months (randomized phase), RestoreX 6-9 months (open label phase)
- Keywords
- Penile traction therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestoreX 1-6 months (randomized phase)Device
Study participants are recommended utilize the device for 30-60 minutes, 5-7 days a week starting at 1 month post-prostatectomy and continuing until 6 months.
RestoreX 6-9 months (open label phase)Device
Both the treatment and control arms will be allowed to use the therapy from 6-9 months post-prostatectomy (open label phase). Only straight traction will be used (no counterbending).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion. Receives: Device: RestoreX 1-6 months (randomized phase); Device: RestoreX 6-9 months (open label phase) |
| Control | Active comparator | Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy. Receives: Device: RestoreX 6-9 months (open label phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Function Post-Prostatectomy
Compare erectile function between treatment and control cohorts, as assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) at 6-months post-prostatectomy. IIEF-EFD scores 1-30, with higher scores representing better function.
Measured: 6 months
Secondary outcomes (8)
Non-erectile function domains of the International Index of Erectile Function
Compare the non-erectile function domains of the International Index of Erectile Function between cohorts. This represents 4 additional scales, with min/max being 0-10, 0-10, 0-15, and 0-10; higher scores indicated better function.
Measured: 6 months
International Index of Erectile Function from baseline to 6 months
Compare International Index of Erectile Function subdomains within cohorts from baseline to 6 months. Scale 1-30, with higher scores representing better outcomes.
Measured: 6 months
Adverse events at 3 months
Evaluate number of participants reporting adverse events at 3 months.
Measured: 3 months
Adverse events at 6 months
Evaluate number of participants reporting adverse events at 6 months
Measured: 6 months
Adverse events at 9 months
Evaluate number of participants reporting adverse events at 9 months
Measured: 9 months
International Index of Erectile Function from baseline to 9 months
Compare International Index of Erectile Function domains at 9 months compared to baseline. Scale is 1-30 with higher scores indicating better function.
Measured: 9 months
International Index of Erectile Function between groups at 9 months
Compare International Index of Erectile Function domains at 9 months between cohorts (treatment arm, control). Scale is 1-30 with higher scores indicating better function.
Measured: 9 months
Subjective questionnaire at 6 months
Compare subjective questionnaire results between cohorts at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start12 Mar 2022
- Primary completion14 Sep 2028 (estimated)
- Study completion14 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once enrolled, patients will be randomized 2:1 to receive either Restorex or control (no treatment) beginning at 1 month post-op until 6 months. They will then enter an open label phase for 3 additional months.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charitable Union for the Research and Education of Peyronie's Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Landon Trost, Charitable Union for the Research and Education of Peyronie's Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244486
- Sponsor's protocol ID
- CUREPD 104
- Status last verified
- Aug 2026
- First submitted
- 8 Feb 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified study results will be made available to other study investigators.
Publications
Zganjar A, Toussi A, Ziegelmann M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial. BJU Int. 2023 Aug;132(2):217-226. doi: 10.1111/bju.16033. Epub 2023 May 9.
PubMed 37088866
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
- ClinicalTrials.gov ID
- NCT05244486
- Acronym / sponsor ID
- CUREPD 104
- Keywords
- Penile traction therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charitable Union for the Research and Education of Peyronie's DiseaseUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 14 Sep 2028 (estimated)
- Study completion
- 14 Sep 2030 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.
Detailed description
Background and Preliminary Data
The treatment of prostate cancer results in several known sexual dysfunctions/risks, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Although all forms of prostate cancer treatment are associated with many of these changes, prostatectomy currently has the most data available on sexual function outcomes. Among the dysfunctions, erectile dysfunction has remained a very challenging adverse effect without effective preventative therapies. Specifically, prior randomized controlled trials evaluating the efficacy of PDE5 inhibitors (vardenafil and tadalafil) have failed to demonstrate improved erectile function preservation post-operatively.
Recently, out team conducted a single-center randomized, controlled trial evaluating the efficacy of a novel penile traction therapy (PTT) device, RestoreX at preventing penile length loss post-prostatectomy. In addition to meeting the primary outcome of achieving improved penile length compared to controls, the study unexpectedly demonstrated improvements in erectile function in the treatment group compared to controls. Results were also consistent with two other prior randomized, controlled trials, one of which demonstrated improved erectile function in men with Peyronie's Disease and the other in men with diabetes mellitus (unpublished).
As these findings represent the first known therapy which resulted in preserved erectile function post-prostatectomy, we sought to perform a larger, multi-center study in an attempt to confirm or refute findings.
Investigational Device
RestoreX is a PTT device developed by PathRight Medical using technology licensed from the Mayo Clinic. The device is classified as class I (orthotic) and does not require clinical trials to prove safety or efficacy. Mayo Clinic has previously performed 3 randomized controlled trials which have confirmed the safety of the device as well as efficacy in improving erectile function and penile length in various cohorts of men.
The device has two functional aspects. The first is the ability to provide direct traction on the penis. The second is the ability to provide counter-bending forces, to treat conditions such as Peyronie's disease (bent penis). In the current study, only the direct traction aspects of the device will be utilized.
Study Rationale
PTT with Restorex has been shown to improve erectile function in several clinical scenarios, including in men with Peyronie's disease, men with diabetes mellitus (unpublished), and post-prostatectomy. As no therapy has ever been shown to improve erectile function or prevent loss of erectile function post-prostatectomy, we felt that there was significant clinical value in performing a large, multi-center, randomized, controlled trial to affirm or refute the efficacy of Restorex PTT in preserving erectile function post-prostatectomy.
Potential Benefits
There are several anticipated benefits to using PTT following prostatectomy. As loss of penile length results in several issues including loss of sexual function, cosmetic concerns, and difficulty in maintaining hygiene (incontinence resulting in yeast infections), the ability to maintain or restore length post-prostatectomy may mitigate these issues. Our team has previously demonstrated that Restorex PTT significantly improved penile length post-prostatectomy. Although this is an anticipated beneficial effect of therapy, we will not be specifically evaluating this outcome in the current study.
In addition to improved penile length, our prior investigations have demonstrated preserved erectile function in men who received PTT with Restorex post-prostatectomy compared to controls. And among all patients in the three prior randomized, controlled trials evaluating Restorex, no significant or long-term adverse events were reported, highlighting the safety of the therapy.
Anticipated Duration of the Clinical Investigation
The overall study will be scheduled for 3 years, to permit adequate time for enrollment and follow-up. The intervention phase will include 5 months of randomized treatment (for the treatment arm), and 3 months of open label treatment (for all arms).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once enrolled, patients will be randomized 2:1 to receive either Restorex or control (no treatment) beginning at 1 month post-op until 6 months. They will then enter an open label phase for 3 additional months.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: RestoreX 1-6 months (randomized phase), Device: RestoreX 6-9 months (open label phase)Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion. |
| Control | Active comparator | Device: RestoreX 6-9 months (open label phase)Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy. |
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)
- Undergoing bilateral nerve-sparing prostatectomy
- >18 years old
- Have a regular sexual partner for at least 6 months prior to study enrollment
Key exclusion criteria (3 listed)
- Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
- Baseline severe erectile dysfunction as measured by the IIEF-EFD
- Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively
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 |
|---|---|---|
| RestoreX 1-6 months (randomized phase)Study participants are recommended utilize the device for 30-60 minutes, 5-7 days a week starting at 1 month post-prostatectomy and continuing until 6 months. | Device | Treatment Arm |
| RestoreX 6-9 months (open label phase)Both the treatment and control arms will be allowed to use the therapy from 6-9 months post-prostatectomy (open label phase). Only straight traction will be used (no counterbending). | Device | Control, Treatment Arm |
Primary outcome
Erectile Function Post-Prostatectomy
Time frame: 6 months
Compare erectile function between treatment and control cohorts, as assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) at 6-months post-prostatectomy. IIEF-EFD scores 1-30, with higher scores representing better function.
8 secondary outcomes
Non-erectile function domains of the International Index of Erectile Function
Time frame: 6 months
International Index of Erectile Function from baseline to 6 months
Time frame: 6 months
Adverse events at 3 months
Time frame: 3 months
Adverse events at 6 months
Time frame: 6 months
Adverse events at 9 months
Time frame: 9 months
International Index of Erectile Function from baseline to 9 months
Time frame: 9 months
International Index of Erectile Function between groups at 9 months
Time frame: 9 months
Subjective questionnaire at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 37088866Zganjar A, Toussi A, Ziegelmann M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial. BJU Int. 2023 Aug;132(2):217-226. doi: 10.1111/bju.16033. Epub 2023 May 9.
- Individual participant dataSharing planned: Yes. De-identified study results will be made available to other study investigators.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RestoreX 1-6 months (randomized phase) and RestoreX 6-9 months (open label phase) in people with Erectile Dysfunction Following Radical Prostatectomy, run by Charitable Union for the Research and Education of Peyronie's Disease at 4 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 3 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Landon Trost, MD (801-655-0015, landontrost@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Function Post-Prostatectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244486, which also lists 1 linked publication.
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 26 Aug 2026.