Erectile DysfunctionNCT07053826
Penile Lengthening Pre-Penile Prosthesis Implantation
A study testing Penile Traction Device and Inflatable Penile Prosthesis Implantation in people with Erectile Dysfunction, run by J. Peter Rubin, MD at 1 site in United States.
Trial summary
The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. 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?
- Penile Traction Device and Inflatable Penile Prosthesis Implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 31 Dec 2027
- 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
- Have a documented diagnosis of erectile dysfunction
- Can provide informed consent
- Are willing and able to comply with study procedures and visit schedules
- Are to be scheduled for a planned standard of care implantation of an inflatable penile prosthesis
Who cannot join
- Prior ischemic priapism
- Prior implantation of a penile prosthesis
- Prior use of any penile traction device
- Any prior penile surgeries other than circumcision
- Prior pelvic radiation
- Current or prior androgen deprivation therapy
- Active genital infection
- History of neophallus creation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Mercy Hospital, Urology
Pittsburgh, Pennsylvania, 15219
Michelle Lucas, MS, 412-624-4708, mcmeansmm2@upmc.edu
Eleanor Shirley, MA, CCRC, shirleye@upmc.edu
About this study
Official title: Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction
The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.
Read the detailed description
Men with erectile dysfunction (ED) refractory to medical therapies are often recommended to undergo placement of an inflatable penile prosthesis (IPP). However, men commonly report a perceived loss of penile length following IPP implantation. This is likely due to one of several factors, including the underlying disease process which resulted in loss of penile length, effects of aging on penile length (loss of elasticity; increased fibrosis), changes in abdominal physiology (development of pre-pubic fat pad that obscures the penis), and recall bias (incorrect recollection of prior penile length).
Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis, including adjunctive surgical maneuvers (excision of suprapubic fat pad, release of suspensory ligament, direct penile extension), use of injectable materials, and pre-operative use of penile traction therapy (PTT). In a small pilot study of 10 men undergoing IPP, Levine and colleagues recommended the use of the Andropenis PTT ≥2 hrs daily for 2-4 months. At 15 months follow-up, patients achieved a +1.6 cm increase compared to pre-traction stretched length, and +0.9 cm increase following prosthesis implantation. Results from a non-validated satisfaction questionnaire demonstrated that no patients reported loss of length following surgery. Unfortunately, the study did not include a control group, thus limiting the conclusions which may be drawn.
Compared to other options, 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. RestoreX is a commercially available PTT device that was developed by the Mayo clinic and has been licensed to PathRight Medical. It has been designated as a Class I device that does not require clinical human trials. The device is currently utilized in 30-minute intervals, with up to 3 sessions performed per day, and has demonstrated efficacy at increasing stretched penile length in patients with postprostatectomy penile shortening and diabetes mellitus.
Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and the limited amount of data that are currently available, we seek to perform a clinical trial evaluating the effect of PTT stretched penile length, size of prosthetic implantation at time of surgery, and patient satisfaction following implantation.
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. In the current study, only the direct traction aspects of the device will be investigated. Men randomized to treatment will be recommended to utilize the device for 30 minutes, 3 times daily for 3 months prior to placement of an IPP, with up to 1.3 additional months to account for variability in surgical timing.
To date, the efficacy of the RestoreX device has been studied in multiple clinical trials, the results of which are briefly outlined below:
- In a randomized, controlled clinical trial, 82 men who underwent prostatectomy for prostate cancer revealed an average increase in stretched penile length of 1.6 cm after 5 months of RestoreX use vs no change for controls (P=0.001). Adverse events were transient and mild, with 87% of men reporting a desire to repeat therapy and 93% of participants reporting that they would recommend it to others.
- In the open-label phase of the study, the benefits of therapy were found to be maintained even after therapy was discontinued.
- In a randomized, single-blind, controlled trial, 110 men with Peyronie's disease were assigned 3:1 to penile traction therapy for three months vs no therapy. At three months, penile traction therapy was associated with a 1.5 cm increase in penile length and 11.7 degree reduction in penile curvature relative to controls. Further, erectile function scores improved 4.3 points relative to a loss of 0.7 points in the control group. The therapy was well tolerated; adverse events were transient and mild.
- Preliminary data also suggest that the RestoreX device can increase penile length on men with diabetes who did not undergo surgery.
Very limited data are available on the efficacy of PTT in men undergoing placement of an IPP. As noted above, a small pilot study of 10 men undergoing IPP demonstrated a +1.6 cm increase in penile length compared to pre-traction stretched length and 0% of men reporting loss of length following surgery.
- Conditions
- Erectile Dysfunction
- Being tested
- Penile Traction Device, Inflatable Penile Prosthesis Implantation
- Keywords
- Erectile Dysfunction, Inflatable Penile Prosthesis, Penile Traction Therapy, RestoreX, Penile Enlargement
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile Traction DeviceDevice
Also called RestoreX, PTT
Patients will be randomized into one of two groups: penile traction therapy 30 min 3x/day x 3 months, or control (no treatment). Preoperative erectile function surveys will be recorded in the EMR per standard of care. Following randomization, patients allocated to the treatment arm will be instructed how to use the device properly. Patients in the treatment arm will record a daily journal of use of the device (Appendix 1). After a minimum of 3 months, patients in the treatment arm will return for their scheduled procedure. Control arm patients will be scheduled directly for an OR date.
Inflatable Penile Prosthesis ImplantationProcedure or surgery
Implantation of a three-component inflatable penile prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Penile Prosthesis Implantation | Active comparator | Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the no intervention arm will proceed directly to implantation of a standard-of-care inflatable penile prosthesis at the next available surgical appointment. They will not use the RestoreX penile traction device. They will complete standardized assessments of sexual function and satisfaction before and after placement. Receives: Procedure: Inflatable Penile Prosthesis Implantation |
| RestoreX and Penile Prosthesis Implantation | Experimental | Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the intervention arm will be provided with a RestoreX penile traction device, which they will utilize for three months prior to implantation of a standard-of-care inflatable penile prosthesis. They will complete standardized assessments of sexual function and satisfaction before and after placement, as well as a device use diary. Receives: Device: Penile Traction Device; Procedure: Inflatable Penile Prosthesis Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile Length
Change in stretched penile length measured at time of enrollment and intraoperatively at the time of IPP implantation, measured in cm.
Measured: At screening to approximately three months after enrollment at the time of penile prosthesis implantation
Prosthesis size
Size of inflatable penile prosthesis cylinders placed
Measured: 0-4 months after enrollment at the time of penile prosthesis implantation
Sexual Satisfaction
Change in patient-reported satisfaction with their sexual function from enrollment to final postoperative follow up using the validated IIEF-15 (International Index of Erectile function - 15 item) questionnaire, which has a minimum score of 6 and maximum score of 75 with a larger number indicating improved sexual satisfaction. The change seen in participants assigned to the RestoreX device arm will be compared to the change seen in patients assigned to the control arm.
Measured: At enrollment and at three-month postoperative follow up.
Incidence of Satisfaction with Penile Length
A comparison of the incidence of participants reporting satisfaction with their penile length, expressed as a percentage or all participants within each group, based on participant reporting to an investigator during their surgical follow up.
Measured: 3-8 months postoperatively
Secondary outcomes (4)
Compliance with Therapy
Patient compliance with traction device regimen using a device use diary will be assessed. Compliance will be reported as a percentage of recommended use sessions completed.
Measured: 0-4 months after enrollment, intervention arm only
Incidence of adverse events
The incidence of all adverse events arising from penile traction therapy device use or inflatable penile prosthesis placement will be monitored throughout the study during in-person encounters and via chart review at the conclusion of the study.
Measured: 0-16 months
Patient Satisfaction with Prosthesis Use
Patient satisfaction with their penile prosthesis will be assessed postoperatively using the validated Quality of Life and Sexuality after Penile Prosthesis (QoLSPP) survey, a 16-item survey with a maximum score of 80 and minimum score of 0, where a higher score corresponds to increased satisfaction. Scores of patients undergoing prosthesis placement alone will be compared to those of patients undergoing RestoreX therapy prior to prosthesis placement.
Measured: 3-7 months
Patient Satisfaction with Prosthesis Use
Patients randomized to RestoreX device use prior to prosthesis placement will be asked if they would use a penile traction device again, and how satisfied they were, on surveys administered immediately prior to, and three months following, prosthesis placement using Likert-style questions.
Measured: 3-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start26 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-armed, controlled, open-label randomized trial assessing the above outcomes in the presence or absence of preoperative penile traction device (RestoreX) use.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J. Peter Rubin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Pathright Medical
- Responsible party
- Sponsor-investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053826
- Sponsor's protocol ID
- STUDY24110037
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of the patients involved in the study, we do not plan to share IDP.
Publications
Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L. Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 2019 Sep;202(3):599-610. doi: 10.1097/JU.0000000000000245. Epub 2019 Aug 8.
PubMed 30916626Zganjar 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 37088866Toussi A, Ziegelmann M, Yang D, Manka M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial. J Urol. 2021 Aug;206(2):416-426. doi: 10.1097/JU.0000000000001792. Epub 2021 Jun 1.
PubMed 34060339Trost LW, Munarriz R, Wang R, Morey A, Levine L. External Mechanical Devices and Vascular Surgery for Erectile Dysfunction. J Sex Med. 2016 Nov;13(11):1579-1617. doi: 10.1016/j.jsxm.2016.09.008.
PubMed 27770853Levine LA, Rybak J. Traction therapy for men with shortened penis prior to penile prosthesis implantation: a pilot study. J Sex Med. 2011 Jul;8(7):2112-7. doi: 10.1111/j.1743-6109.2011.02285.x. Epub 2011 Apr 14.
PubMed 21492409
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07053826
- Acronym / sponsor ID
- STUDY24110037
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Inflatable Penile Prosthesis, Penile Traction Therapy, RestoreX, Penile Enlargement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- J. Peter Rubin, MDUniversity, hospital or other
- Collaborators
- Pathright Medical
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jul 2025 (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.
The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.
Detailed description
Men with erectile dysfunction (ED) refractory to medical therapies are often recommended to undergo placement of an inflatable penile prosthesis (IPP). However, men commonly report a perceived loss of penile length following IPP implantation. This is likely due to one of several factors, including the underlying disease process which resulted in loss of penile length, effects of aging on penile length (loss of elasticity; increased fibrosis), changes in abdominal physiology (development of pre-pubic fat pad that obscures the penis), and recall bias (incorrect recollection of prior penile length).
Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis, including adjunctive surgical maneuvers (excision of suprapubic fat pad, release of suspensory ligament, direct penile extension), use of injectable materials, and pre-operative use of penile traction therapy (PTT). In a small pilot study of 10 men undergoing IPP, Levine and colleagues recommended the use of the Andropenis PTT ≥2 hrs daily for 2-4 months. At 15 months follow-up, patients achieved a +1.6 cm increase compared to pre-traction stretched length, and +0.9 cm increase following prosthesis implantation. Results from a non-validated satisfaction questionnaire demonstrated that no patients reported loss of length following surgery. Unfortunately, the study did not include a control group, thus limiting the conclusions which may be drawn.
Compared to other options, 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. RestoreX is a commercially available PTT device that was developed by the Mayo clinic and has been licensed to PathRight Medical. It has been designated as a Class I device that does not require clinical human trials. The device is currently utilized in 30-minute intervals, with up to 3 sessions performed per day, and has demonstrated efficacy at increasing stretched penile length in patients with postprostatectomy penile shortening and diabetes mellitus.
Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and the limited amount of data that are currently available, we seek to perform a clinical trial evaluating the effect of PTT stretched penile length, size of prosthetic implantation at time of surgery, and patient satisfaction following implantation.
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. In the current study, only the direct traction aspects of the device will be investigated. Men randomized to treatment will be recommended to utilize the device for 30 minutes, 3 times daily for 3 months prior to placement of an IPP, with up to 1.3 additional months to account for variability in surgical timing.
To date, the efficacy of the RestoreX device has been studied in multiple clinical trials, the results of which are briefly outlined below:
- In a randomized, controlled clinical trial, 82 men who underwent prostatectomy for prostate cancer revealed an average increase in stretched penile length of 1.6 cm after 5 months of RestoreX use vs no change for controls (P=0.001). Adverse events were transient and mild, with 87% of men reporting a desire to repeat therapy and 93% of participants reporting that they would recommend it to others.
- In the open-label phase of the study, the benefits of therapy were found to be maintained even after therapy was discontinued.
- In a randomized, single-blind, controlled trial, 110 men with Peyronie's disease were assigned 3:1 to penile traction therapy for three months vs no therapy. At three months, penile traction therapy was associated with a 1.5 cm increase in penile length and 11.7 degree reduction in penile curvature relative to controls. Further, erectile function scores improved 4.3 points relative to a loss of 0.7 points in the control group. The therapy was well tolerated; adverse events were transient and mild.
- Preliminary data also suggest that the RestoreX device can increase penile length on men with diabetes who did not undergo surgery.
Very limited data are available on the efficacy of PTT in men undergoing placement of an IPP. As noted above, a small pilot study of 10 men undergoing IPP demonstrated a +1.6 cm increase in penile length compared to pre-traction stretched length and 0% of men reporting loss of length following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a double-armed, controlled, open-label randomized trial assessing the above outcomes in the presence or absence of preoperative penile traction device (RestoreX) use.
| Arm | Type | Receives |
|---|---|---|
| Penile Prosthesis Implantation | Active comparator | Procedure: Inflatable Penile Prosthesis ImplantationPatients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the no intervention arm will proceed directly to implantation of a standard-of-care inflatable penile prosthesis at the next available surgical appointment. They will not use the RestoreX penile traction device. They will complete standardized assessments of sexual function and satisfaction before and after placement. |
| RestoreX and Penile Prosthesis Implantation | Experimental | Device: Penile Traction Device, Procedure: Inflatable Penile Prosthesis ImplantationPatients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the intervention arm will be provided with a RestoreX penile traction device, which they will utilize for three months prior to implantation of a standard-of-care inflatable penile prosthesis. They will complete standardized assessments of sexual function and satisfaction before and after placement, as well as a device use diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a documented diagnosis of erectile dysfunction
- Can provide informed consent
- Are willing and able to comply with study procedures and visit schedules
- Are to be scheduled for a planned standard of care implantation of an inflatable penile prosthesis
Key exclusion criteria (8 listed)
- Prior ischemic priapism
- Prior implantation of a penile prosthesis
- Prior use of any penile traction device
- Any prior penile surgeries other than circumcision
- Prior pelvic radiation
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 |
|---|---|---|
| Penile Traction DeviceAlso: RestoreX, PTTPatients will be randomized into one of two groups: penile traction therapy 30 min 3x/day x 3 months, or control (no treatment). Preoperative erectile function surveys will be recorded in the EMR per standard of care. Following randomization, patients allocated to the treatment arm will be instructed how to use the device properly. Patients in the treatment arm will record a daily journal of use of the device (Appendix 1). After a minimum of 3 months, patients in the treatment arm will return for their scheduled procedure. Control arm patients will be scheduled directly for an OR date. | Device | RestoreX and Penile Prosthesis Implantation |
| Inflatable Penile Prosthesis ImplantationImplantation of a three-component inflatable penile prosthesis. | Procedure or surgery | Penile Prosthesis Implantation, RestoreX and Penile Prosthesis Implantation |
Primary outcome
Penile Length
Time frame: At screening to approximately three months after enrollment at the time of penile prosthesis implantation
Change in stretched penile length measured at time of enrollment and intraoperatively at the time of IPP implantation, measured in cm.
Prosthesis size
Time frame: 0-4 months after enrollment at the time of penile prosthesis implantation
Size of inflatable penile prosthesis cylinders placed
Sexual Satisfaction
Time frame: At enrollment and at three-month postoperative follow up.
Change in patient-reported satisfaction with their sexual function from enrollment to final postoperative follow up using the validated IIEF-15 (International Index of Erectile function - 15 item) questionnaire, which has a minimum score of 6 and maximum score of 75 with a larger number indicating improved sexual satisfaction. The change seen in participants assigned to the RestoreX device arm will be compared to the change seen in patients assigned to the control arm.
Incidence of Satisfaction with Penile Length
Time frame: 3-8 months postoperatively
A comparison of the incidence of participants reporting satisfaction with their penile length, expressed as a percentage or all participants within each group, based on participant reporting to an investigator during their surgical follow up.
4 secondary outcomes
Compliance with Therapy
Time frame: 0-4 months after enrollment, intervention arm only
Incidence of adverse events
Time frame: 0-16 months
Patient Satisfaction with Prosthesis Use
Time frame: 3-7 months
Patient Satisfaction with Prosthesis Use
Time frame: 3-8 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 3 Sep 2026.
- Background: PubMed 30916626Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L. Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 2019 Sep;202(3):599-610. doi: 10.1097/JU.0000000000000245. Epub 2019 Aug 8.
- Background: 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.
- Background: PubMed 34060339Toussi A, Ziegelmann M, Yang D, Manka M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial. J Urol. 2021 Aug;206(2):416-426. doi: 10.1097/JU.0000000000001792. Epub 2021 Jun 1.
- Background: PubMed 27770853Trost LW, Munarriz R, Wang R, Morey A, Levine L. External Mechanical Devices and Vascular Surgery for Erectile Dysfunction. J Sex Med. 2016 Nov;13(11):1579-1617. doi: 10.1016/j.jsxm.2016.09.008.
- Background: PubMed 21492409Levine LA, Rybak J. Traction therapy for men with shortened penis prior to penile prosthesis implantation: a pilot study. J Sex Med. 2011 Jul;8(7):2112-7. doi: 10.1111/j.1743-6109.2011.02285.x. Epub 2011 Apr 14.
- Individual participant dataSharing planned: No. To protect the privacy of the patients involved in the study, we do not plan to share IDP.
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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.
J. Peter Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penile Traction Device and Inflatable Penile Prosthesis Implantation in people with Erectile Dysfunction, run by J. Peter Rubin, MD at 1 site 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 4 inclusion and 8 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Roger D Klein, MD, PhD (800-533-8762, urologyresearch@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile Length (time frame: At screening to approximately three months after enrollment at the time of penile prosthesis implantation). The study lists 4 primary outcomes in all. 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 NCT07053826, which also lists 5 linked publications.
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 3 Sep 2026.