Clinical trial · Interventional
Penile Length Maintenance Post-Prostatectomy
NCT03500419CI-TRIAL-00054569completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Penile Diseases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No treatment | Other | — | UNRESOLVED |
| RestoreX | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- No treatment will be administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
- interventionNames
- Other: No treatment
- type
- EXPERIMENTAL
- label
- Group AB - PTT 1-2x daily x 5-7 days/week x 5 months
- description
- Men will utilize penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months.
- interventionNames
- Device: RestoreX
Primary outcomes (1)
- measure
- Change in Penile Length
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing robotic prostatectomy * Seen in the post-prostatectomy rehab clinic Exclusion Criteria: • Urethral complications from prostatectomy at the time of baseline visit
References
Publications (0)
Data not yet available
No reference posted for this study.