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PI changed subspecialties and no longer had access to main study population
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This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.
Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously.
Several attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers several potential advantages in that it is minimally-invasive, does not increase the morbidity of surgery, and has not been shown to result in any long-term side effects.
A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and limited amount of data available, we sought to perform a clinical trial evaluating the effect of PTT on increasing the total length of prosthesis which can be inserted. We additionally sought to determine if PTT resulted in improved post-operative satisfaction on total penile length achieved.
To accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to publish in a scientific journal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Control | Sham Comparator | No treatment will be administered and men will not have to delay their IPP procedure |
|
| Group 2 - PTT 3x daily x 3 months | Experimental | Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RestoreX | Device | Penile traction therapy in the straight position |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Length Assessment of Penile Prosthesis Implanted | The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment) | From baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Compliance | Compare Participant compliance with traction device | From baseline to 3 months |
| Participant Satisfaction With Traction | Compare patient reported satisfaction with use of traction device |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Landon W Trost | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States | ||
| Washington University School of Medicine |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Control | No treatment will be administered and men will not have to delay their IPP procedure Control: No treatment |
| FG001 | Group 2 - PTT 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP RestoreX: Penile traction therapy in the straight position |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Control | No treatment will be administered and men will not have to delay their IPP procedure Control: No treatment |
| BG001 | Group 2 - PTT 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP RestoreX: Penile traction therapy in the straight position |
| 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 | Length Assessment of Penile Prosthesis Implanted | The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment) | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | From baseline to 3 months |
|
Adverse events were collected three months post prosthesis implantation. However, this study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
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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 | Group 1 - Control | No treatment will be administered and men will not have to delay their IPP procedure Control: No treatment |
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Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.
| 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 | Oct 10, 2018 | Nov 8, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Control |
| Other |
No treatment |
|
| From baseline to 3 months |
| Adverse Events With Use of Traction | Evaluate any adverse events with use of RestoreX® for penile lengthening. | From baseline to 3 months |
| Operative Complications | Compare intra- and/or post-operative complication rates. | 3, 6, 12 months post-operative |
| Stretched Penile Length | Compare pre- and post-operative stretched penile lengths | From baseline to 12 months |
| Participant Satisfaction Penile Length | Compare participant satisfaction scores including satisfaction with overall penile length | Baseline to 12 months post-operative |
| St Louis |
| Missouri |
| 63110 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Participant Compliance | Compare Participant compliance with traction device | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | From baseline to 3 months |
|
|
| Secondary | Participant Satisfaction With Traction | Compare patient reported satisfaction with use of traction device | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | From baseline to 3 months |
|
|
| Secondary | Adverse Events With Use of Traction | Evaluate any adverse events with use of RestoreX® for penile lengthening. | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | From baseline to 3 months |
|
|
| Secondary | Operative Complications | Compare intra- and/or post-operative complication rates. | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | 3, 6, 12 months post-operative |
|
|
| Secondary | Stretched Penile Length | Compare pre- and post-operative stretched penile lengths | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | From baseline to 12 months |
|
|
| Secondary | Participant Satisfaction Penile Length | Compare participant satisfaction scores including satisfaction with overall penile length | Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data. | Posted | Baseline to 12 months post-operative |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Group 2 - PTT 3x Daily x 3 Months | Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP RestoreX: Penile traction therapy in the straight position | 0 | 20 | 0 | 20 | 0 | 20 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |