NCT03389854|CompletedResultsFDA Device
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Sponsor study identifier
interventional
110
1 country
1
Study Start
October 2, 2017
Actual (reported)Primary Completion
June 4, 2019
Actual (reported)Study Completion
June 4, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 4, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2017
Actual (reported)October 19, 2017
Actual (reported)January 4, 2018
Actual (reported)June 4, 2019
Actual (reported)June 4, 2019
Actual (reported)August 12, 2020
Actual (reported)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
Change in Penile Length to Corona
3 months, 6 months
Change in Penile Length to Tip
3 months, 6 months
Change in Penile Curvature
3 months, 6 months
Change Erectile Function
3 months, 6 months
Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ)
Baseline, 3 months
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.
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.
Penile traction therapy in the straight and bent positions
Penile traction therapy in the straight and bent positions
Mayo Clinic
Rochester, Minnesota, 55905, United States
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.
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.
Landon Trost, MD
Mayo Clinic
110 participants (actual enrollment reported by the registry).
Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Submitted
October 19, 2017
First Posted
January 4, 2018
Study Start
October 2, 2017
Actual (reported)Primary Completion
June 4, 2019
Actual (reported)Study Completion
June 4, 2019
Actual (reported)Last Updated
August 12, 2020
Results First Posted
August 12, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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