Efficacy of Penile Traction Therapy Using a Novel Device

Penile Diseases Clinical Trial

Official title:

Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389854
• Other study ID #: 17-001283
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: June 4, 2019

Study information

• Verified date: August 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Peyronie's disease

• Current 30 degree curvature in a single plane (i.e. 20 degrees up, 15 degrees left would not be a candidate)

• Not undergoing other therapies for PD currently

Exclusion Criteria:

• Stretched penile length <7 cm

• Prisoners

• Erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies

• Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)

Related Conditions & MeSH terms

• Penile Diseases

Intervention

Device:
• RestoreX PTT - randomized and open label
Penile traction therapy in the straight and bent positions
• RestoreX PTT - open label phase only
Penile traction therapy in the straight and bent positions

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline
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	3 months
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	6 months
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	9 months
Secondary	Change in Penile Length to Corona	Stretched penile length measured in centimeters from pubic symphysis to glanular corona	3 months, 6 months
Secondary	Change in Penile Length to Tip	Stretched penile length measured in centimeters from pubic symphysis to penile tip	3 months, 6 months
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.	3 months, 6 months
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.	3 months, 6 months
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.	Baseline, 3 months
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.	Baseline, 3 months
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.	Baseline, 3 month
Secondary	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
Secondary	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
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	3 months
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%.	3 months
Secondary	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

External Links

•   Mayo Clinic Clinical Trials