Diabetes Mellitus, Type 2NCT03756688
Penile Length Restoration in Men With Diabetes Mellitus, Type II
A study testing RestoreX PTT - 6 months and RestoreX PTT - 3 months in people with Diabetes Mellitus, Type 2 and Penile Diseases, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Penile Diseases
- What is being tested?
- RestoreX PTT - 6 months and RestoreX PTT - 3 months
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 18 Mar 2021
- 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 with Diabetes Mellitus, Type II
Who cannot join
- Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
- Loss of fingers / toes.
- CKD Stage IV or greater.
- Retinopathy
- Myocardial infarction.
- Cerebrovascular accident.
- Indwelling penile prosthesis or prior history of penile prosthesis.
- Peyronie's disease at baseline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.
Read the detailed description
Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate compared to men without diabetes. One of these sexual dysfunctions includes diminished penile length. It is currently unknown if the decreased length is due to earlier erectile dysfunction or secondary to diabetes itself. Penile traction therapy is one of several treatments which have been used historically to treat decreased penile length, however, to date, no studies have evaluated the role of traction therapy in men with diabetes. To accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type II will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used with the intent to publish in a scientific journal.
- Conditions
- Diabetes Mellitus, Type 2, Penile Diseases
- Being tested
- RestoreX PTT - 6 months, RestoreX PTT - 3 months
- Medical subject headings
- Diabetes Mellitus, Type 2, Penile Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestoreX PTT - 6 monthsDevice
Penile traction therapy in straight position for all 6 months.
RestoreX PTT - 3 monthsDevice
Penile traction therapy in straight position for first phase (3 months)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control | No intervention | No treatment will be administered for the entirety of the study (6 months) |
| Group 2: Treatment | Experimental | PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months Receives: Device: RestoreX PTT - 3 months |
| Group 3: Treatment | Experimental | PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months Receives: Device: RestoreX PTT - 6 months |
| Group 4: Treatment | Experimental | PTT for 30 min 2x day x 6 months Receives: Device: RestoreX PTT - 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile Length Change Between Baseline and Month 6
Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
Measured: Baseline to 6 months
Secondary outcomes (6)
Patient Compliance With Traction Therapy
Records of use from daily journals
Measured: 6 months
Patient Reported Satisfaction With Traction Therapy at 6 Months.
Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy.
Measured: 6 months
Number of Participants With Adverse Events With Use of RestoreX
Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.
Measured: 3 and 6 months post-prostatectomy
Number of Participants With De-novo Peyronie's Disease Development
Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period
Measured: 6 months
Subjective Comparison of Changes in Penile Length
Subjective questions on patient perceived improvement in length (yes/no, qualitative [large, medium, small, none]); note that some groups add to >100% due to the effects of rounding.
Measured: 6 months
Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
Standardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain [questions 1-5 and 15]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start7 Nov 2018
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
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 Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Factorial
- Model description
- Patients will be randomized into one of four groups: 1. Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months 2. PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months 3. PTT for 30 min 2x/day x 6 months 4. Control (no treatment)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew (Matt) J. Ziegelmann, Mayo Clinic
- Investigators
- Matthew Ziegelmann, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756688
- Sponsor's protocol ID
- 18-006696
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2018
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Length Restoration in Men With Diabetes Mellitus, Type II
- ClinicalTrials.gov ID
- NCT03756688
- Acronym / sponsor ID
- 18-006696
- Conditions
- Diabetes Mellitus, Type 2, Penile Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.
Detailed description
Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate compared to men without diabetes. One of these sexual dysfunctions includes diminished penile length. It is currently unknown if the decreased length is due to earlier erectile dysfunction or secondary to diabetes itself. Penile traction therapy is one of several treatments which have been used historically to treat decreased penile length, however, to date, no studies have evaluated the role of traction therapy in men with diabetes. To accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type II will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used with the intent to publish in a scientific journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be randomized into one of four groups: 1. Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months 2. PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months 3. PTT for 30 min 2x/day x 6 months 4. Control (no treatment)
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control | No intervention | –No treatment will be administered for the entirety of the study (6 months) |
| Group 2: Treatment | Experimental | Device: RestoreX PTT - 3 monthsPTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months |
| Group 3: Treatment | Experimental | Device: RestoreX PTT - 6 monthsPTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months |
| Group 4: Treatment | Experimental | Device: RestoreX PTT - 6 monthsPTT for 30 min 2x day x 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with Diabetes Mellitus, Type II
Key exclusion criteria (8 listed)
- Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
- Loss of fingers / toes.
- CKD Stage IV or greater.
- Retinopathy
- Myocardial infarction.
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 PTT - 6 monthsPenile traction therapy in straight position for all 6 months. | Device | Group 3: Treatment, Group 4: Treatment |
| RestoreX PTT - 3 monthsPenile traction therapy in straight position for first phase (3 months) | Device | Group 2: Treatment |
Primary outcome
Penile Length Change Between Baseline and Month 6
Time frame: Baseline to 6 months
Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
6 secondary outcomes
Patient Compliance With Traction Therapy
Time frame: 6 months
Patient Reported Satisfaction With Traction Therapy at 6 Months.
Time frame: 6 months
Number of Participants With Adverse Events With Use of RestoreX
Time frame: 3 and 6 months post-prostatectomy
Number of Participants With De-novo Peyronie's Disease Development
Time frame: 6 months
Subjective Comparison of Changes in Penile Length
Time frame: 6 months
Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Matthew Ziegelmann, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RestoreX PTT - 6 months and RestoreX PTT - 3 months in people with Diabetes Mellitus, Type 2 and Penile Diseases, run by Mayo Clinic 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 1 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: finished, as of the sponsor's last update on 21 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). 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?
Penile Length Change Between Baseline and Month 6 (time frame: Baseline to 6 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 21 Feb 2023.