N/A
N=110
Efficacy of Penile Traction Therapy Using a Novel Device
Penile Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03389854 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Adverse Events at Baseline — 2; 2; 1; 7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RestoreX PTT - randomized and open label (Device); RestoreX PTT - open label phase only (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events at Baseline |
2; 2; 1; 7; 10; 7 | — |
| PRIMARY Adverse Events at 3 Months |
43; 41; 37; 10; 14; 16 | — |
| PRIMARY Adverse Events at 6 Months |
35; 5; 27 | — |
| PRIMARY Adverse Events at 9 Months |
4; 4 | — |
| SECONDARY Change in Penile Length to Corona |
0.3; 1.3; 2.0; 2.3 | 0.001 sig |
| SECONDARY Change in Penile Length to Tip |
0.0; 1.5; 1.6; 1.9 | 0.001 sig |
| SECONDARY Change in Penile Curvature |
1.3; -11.7; -12.5; -14.9 | 0.01 sig |
| SECONDARY Change Erectile Function |
-1.3; 2.5; 1.8; 4.4 | 0.06 |
| SECONDARY Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) |
-0.6; -2.3 | 0.09 |
| SECONDARY Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) |
-0.8; -1.4 | 0.26 |
| SECONDARY Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) |
-0.9; -2.4 | 0.07 |
| SECONDARY Overall Treatment Satisfaction |
25.4; 41.3; 30.2; 3.2; 0 | — |
| SECONDARY Ability to Achieve Sexual Intercourse |
0; 4 | — |
| SECONDARY Satisfaction With the RestoreX® Device to Alternative Forms of PTT |
86.7; 13.3; 0; 0; 0 | — |
| SECONDARY Satisfaction With the RestoreX® Device to Alternative PD Therapies |
74.1; 23.6; 14.8; 5.6; 1.8; 1.8 | — |
| SECONDARY Ability to Achieve Sexual Intercourse |
0; 4 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03389854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.