N/A
N=110
Penile Length Restoration in Men With Diabetes Mellitus, Type II
Diabetes Mellitus, Type 2 · Penile Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03756688 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Penile Length Change Between Baseline and Month 6 — 0; 0.5; 0.5; 0.8 Median change from baseline (cm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RestoreX PTT - 6 months (Device); RestoreX PTT - 3 months (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Penile Length Change Between Baseline and Month 6 |
0; 0.5; 0.5; 0.8 | — |
| SECONDARY Patient Compliance With Traction Therapy |
93.5; 91.5; 85.2 | — |
| SECONDARY Patient Reported Satisfaction With Traction Therapy at 6 Months. |
7.5; 8; 8 | — |
| SECONDARY Number of Participants With Adverse Events With Use of RestoreX |
2; 2; 2; 1; 0; 1 | — |
| SECONDARY Number of Participants With De-novo Peyronie's Disease Development |
1; 2; 1; 1 | — |
| SECONDARY Subjective Comparison of Changes in Penile Length |
0; 36; 63; 65; 0; 36 | — |
| SECONDARY Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months. |
0; 1.1; 4.2; 4.3 | — |
Summary
The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- Men with Diabetes Mellitus, Type II
Exclusion Criteria
- Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
- Loss of fingers / toes.
- CKD Stage IV or greater.
- Retinopathy
- Myocardial infarction.
- Cerebrovascular accident.
- Indwelling penile prosthesis or prior history of penile prosthesis.
- Peyronie's disease at baseline.
Data sourced from ClinicalTrials.gov (NCT03756688). 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.