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This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.
Peyronie's disease (PD) is a fibrotic condition of the penis, affecting 1-13% of the US male population. The disease results in penile curvature and significant psychosocial bother. Current preferred therapies for PD include repeated penile injections with bacterial enzymes and surgery. However, these therapies are expensive and in some cases result in permanent reductions in penile length and sensation. Penile traction therapy (PTT) is a relatively newer treatment which has been proposed as a treatment for PD with preliminary data suggesting a potential role. However, currently available PTT devices are primarily designed for penile lengthening and have many significant limitations including a requirement of use for 9 hours daily and significant difficulties in personal application. Given these limitations, a new penile traction device (RestoreX® ) was created and funded through Mayo Ventures and was specifically designed to treat men with PD. The primary objective of the current study is to evaluate safety of the device using various dosing schedules, with secondary endpoints designed to assess efficacy and subjective outcomes. To accomplish the study, a population of men from Mayo Clinic with PD will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 3, 6, and 9 months, and results are to be used with the intent to publish in a scientific journal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Control | Sham Comparator | No treatment will be administered for the initial 3 months. This are is necessary as Peyronie's disease may result in changes in length and curvature as a function of the disease process. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired. |
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| Group 2 - PTT 1x daily x 3 months | Experimental | Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
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| Group 3 - PTT 2x daily x 3 months | Experimental | Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
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| Group 4 - PTT 3x daily x 3 months | Experimental | Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RestoreX PTT - randomized and open label | Device | Penile traction therapy in the straight and bent positions |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events at Baseline | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | Baseline |
| Adverse Events at 3 Months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | 3 months |
| Adverse Events at 6 Months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | 6 months |
| Adverse Events at 9 Months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Penile Length to Corona | Stretched penile length measured in centimeters from pubic symphysis to glanular corona | 3 months, 6 months |
| Change in Penile Length to Tip | Stretched penile length measured in centimeters from pubic symphysis to penile tip |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Landon Trost, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33223425 | Derived | Joseph J, Ziegelmann MJ, Alom M, Savage J, Kohler TS, Trost L. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex Med. 2020 Dec;17(12):2462-2471. doi: 10.1016/j.jsxm.2020.10.003. Epub 2020 Nov 20. | |
| 30916626 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | No treatment will be administered for the initial 3 months. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired. |
| FG001 | Penile Traction Therapy Group 1x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| FG002 | Penile Traction Therapy Group 2x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| FG003 | Penile Traction Therapy Group 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | No treatment will be administered for the initial 3 months. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired. |
| BG001 | Penile Traction Therapy Group 1x Daily x 3 Months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events at Baseline | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | Posted | Number | percentage of participants | Baseline |
|
Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Penile Traction Therapy Group 1x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Penile erythema or discoloration, transient | Reproductive system and breast disorders | Systematic Assessment | 3 month outcomes among men in PTT group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Landon Trost | Mayo Clinic | 507-284-3728 | Trost.Landon@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2018 | Apr 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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Men will be randomized into one of four groups: no traction therapy, penile traction 30 minutes once daily, penile traction 30 minutes twice daily, and penile traction 30 minutes three times daily. This treatment will continue for 3 months, after which men will enter an open label phase for 3 months. Primary and secondary outcomes will be evaluated at the completion of the 3 month and 6 month time points. Additional AEs will be assessed at 9 months after study initiation.
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Objective outcomes including penile length and curvature will be masked for the investigator and outcome assessor by obtaining photographs of the penis in the lateral and dorsal planes. Curvatures will also be assessed by a clinician in the case where photographs are not able to be obtained or if the participant refuses photographs. These will be assessed without any knowledge as to which grouping the patient is located by two independent reviewers. If there are differences >5 degrees (curvature), or 0.5 cm (length), a 3rd individual will mediate the difference.
| RestoreX PTT - open label phase only | Device | Penile traction therapy in the straight and bent positions |
|
| 3 months, 6 months |
| Change in Penile Curvature | Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature. | 3 months, 6 months |
| Change Erectile Function | Self reported International Index of Erectile Function (IIEF) questionnaire for erectile dysfunction (ED) scored on a scale of <11 severe ED, 11-16 moderate ED, 17-25 mild ED, 26-30 no ED. Questionnaires were given to participants at baseline, 3 months and 6 months. Change in the score was reported for 3 months and 6 months. | 3 months, 6 months |
| Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) | Self reported Peyronie's Disease questionnaire (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions with a total score range 0 to 24. Negative denotes improvement. | Baseline, 3 months |
| Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) | Self reported Peyronie's Disease questionnaire penile pain scale range 0 (no pain) and 10 (extreme pain) on 3 questions with a total score range 0 to 30. Negative denotes improvement. | Baseline, 3 months |
| Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | Self reported Peyronie's Disease questionnaire bother score range 0 (no issue or not at all bothered) and 4 (extremely bothered) on 4 questions with a total score range 0 to 16. Negative denotes improvement. | Baseline, 3 month |
| Overall Treatment Satisfaction | Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied | 3 months |
| Ability to Achieve Sexual Intercourse | Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate" | 3 months |
| Satisfaction With the RestoreX® Device to Alternative Forms of PTT | Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse | 3 months |
| Satisfaction With the RestoreX® Device to Alternative PD Therapies | Subjects being treated for PD the first time were asked which therapies they would choose. Respondents could select more than 1 option so values equal greater than 100%. | 3 months |
| Ability to Achieve Sexual Intercourse | Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate" | 6 months |
Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| BG002 | Penile Traction Therapy Group 2x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| BG003 | Penile Traction Therapy Group 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | Penile Traction Therapy Group 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. |
|
|
| Primary | Adverse Events at 3 Months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | Posted | Number | percentage of participants | 3 months |
|
|
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| Primary | Adverse Events at 6 Months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | Posted | Number | percentage of participants | 6 months |
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| Primary | Adverse Events at 9 Months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other | Posted | Number | percentage of participants | 9 months |
|
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| Secondary | Change in Penile Length to Corona | Stretched penile length measured in centimeters from pubic symphysis to glanular corona | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Data for 27 subjects control group and 62 subjects PTT group available for analysis at 3 mo. Data for 14 subjects original control group and 37 subjects original PTT group available for analysis at 6 mo. | Posted | Mean | Standard Deviation | Centimeters | 3 months, 6 months |
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| Secondary | Change in Penile Length to Tip | Stretched penile length measured in centimeters from pubic symphysis to penile tip | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Data for 27 subjects control group and 62 subjects PTT group available for analysis at 3 mo. Data for 14 subjects original control group and 37 subjects original PTT group available for analysis at 6 mo. | Posted | Mean | Standard Deviation | Centimeters | 3 months, 6 months |
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| Secondary | Change in Penile Curvature | Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature. | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Data for 27 subjects control group and 62 subjects PTT group available for analysis at 3 mo. Data for 14 subjects original control group and 37 subjects original PTT group available for analysis at 6 mo. | Posted | Mean | Standard Deviation | degrees | 3 months, 6 months |
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| Secondary | Change Erectile Function | Self reported International Index of Erectile Function (IIEF) questionnaire for erectile dysfunction (ED) scored on a scale of <11 severe ED, 11-16 moderate ED, 17-25 mild ED, 26-30 no ED. Questionnaires were given to participants at baseline, 3 months and 6 months. Change in the score was reported for 3 months and 6 months. | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Questionnaire 26 subjects control group and 59 subjects PTT group available for analysis 3 mo. Questionnaire 14 subjects original control group and 37 subjects original PTT group available for analysis 6 mo. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months |
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| Secondary | Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) | Self reported Peyronie's Disease questionnaire (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions with a total score range 0 to 24. Negative denotes improvement. | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
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| Secondary | Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) | Self reported Peyronie's Disease questionnaire penile pain scale range 0 (no pain) and 10 (extreme pain) on 3 questions with a total score range 0 to 30. Negative denotes improvement. | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
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| Secondary | Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | Self reported Peyronie's Disease questionnaire bother score range 0 (no issue or not at all bothered) and 4 (extremely bothered) on 4 questions with a total score range 0 to 16. Negative denotes improvement. | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 month |
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| Secondary | Overall Treatment Satisfaction | Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Number | percentage of participants | 3 months |
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| Secondary | Ability to Achieve Sexual Intercourse | Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate" | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Number | percentage of participants | 3 months |
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| Secondary | Satisfaction With the RestoreX® Device to Alternative Forms of PTT | Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Number | percentage of participants | 3 months |
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| Secondary | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Subjects being treated for PD the first time were asked which therapies they would choose. Respondents could select more than 1 option so values equal greater than 100%. | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Number | percentage of participants | 3 months |
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| Secondary | Ability to Achieve Sexual Intercourse | Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate" | It was pre-specified to combine Penile Traction Therapy Groups for this analysis. | Posted | Number | percentage of participants | 6 months |
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| 0 |
| 27 |
| 0 |
| 27 |
| 16 |
| 27 |
| EG001 | Penile Traction Therapy Group 2x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. | 0 | 28 | 0 | 28 | 15 | 28 |
| EG002 | Penile Traction Therapy Group 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. | 0 | 27 | 0 | 27 | 13 | 27 |
| EG003 | Open Label Period Penile Traction Therapy | After the initial 3 month study period subjects from both the control group and the penile traction therapy group will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. | 0 | 63 | 0 | 63 | 28 | 63 |
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| Loss or abnormal penile sensation, transient (new onset for 6-, 9-month cohorts) | Reproductive system and breast disorders | Systematic Assessment | Total includes men who either had symptom at 6 or 9 months |
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| New penile pain, transient (mild) | Reproductive system and breast disorders | Systematic Assessment | At 3 month time point (among men treated with traction) |
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| Male |
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| Transient Discomfort |
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| Title | Measurements |
|---|---|
|
| 6 month |
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| 0.90 |
| Superiority |
| 6 months |
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| 0.40 |
| Superiority |
| 6 months |
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| 0.64 |
| Superiority |
| 6 months |
|
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| 0.66 |
| Superiority |
| Title | Measurements |
|---|---|
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| % Somewhat dissatisfied |
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| % Very dissatisfied |
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| Title | Measurements |
|---|---|
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| % RestoreX is somewhat worse |
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| % RestoreX is much worse |
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| Title | Measurements |
|---|---|
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| Vacuum erection device |
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| Surgery |
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| Other therapy |
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| Other traction device |
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