N/A
N=82
Penile Length Maintenance Post-Prostatectomy
Prostate Cancer · Penile Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03500419 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Change in Penile Length — 0.3; 1.6 centimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RestoreX (Device); No treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Penile Length |
0.3; 1.6 | — |
| SECONDARY Erectogenic Therapy Use |
94; 86 | — |
| SECONDARY Intracavernosal Injections |
50; 19 | — |
| SECONDARY Change in Erectile Function Domain of International Index of Erectile Function (IIEF) |
-6.5; 0 | — |
| SECONDARY Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF) |
-3.5; 1 | — |
| SECONDARY Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF) |
-3; 0 | — |
Summary
The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.
Eligibility Criteria
Inclusion Criteria
- Undergoing robotic prostatectomy
- Seen in the post-prostatectomy rehab clinic
Exclusion Criteria
- Urethral complications from prostatectomy at the time of baseline visit
Data sourced from ClinicalTrials.gov (NCT03500419). 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.