Clinical trial · Interventional
Efficacy of the Pelvic Clock® Device for Functional Recovery After Robotic-Assisted Radical Prostatectomy
Efficacy of the Pelvic Clock® Device on Functional Recovery After Robotic-Assisted Radical Prostatectomy: A Randomized Controlled Trial
- 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)
This randomized controlled trial evaluates the efficacy of the Pelvic Clock® device, a proprioceptive neuromuscular facilitation tool, in accelerating functional recovery following Robotic-Assisted Radical Prostatectomy (RARP). The study compares the device intervention against standard Pelvic Floor Muscle Training (PFMT) instructions. The primary goal is to assess the "Trifecta" achievement rate (cancer control, urinary continence, and potency) at 6 months post-surgery.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic Clock® | Device | — | UNRESOLVED |
| Standard Pelvic Floor Muscle Training (PFMT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Pelvic Clock Group
- description
- Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen.
- interventionNames
- Device: Pelvic Clock®
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Control Group
- description
- Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT).
- interventionNames
- Behavioral: Standard Pelvic Floor Muscle Training (PFMT)
Primary outcomes (1)
- measure
- Trifecta Achievement Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with localized prostate cancer. * Scheduled for Robotic-Assisted Radical Prostatectomy (RARP). * Age between 55 and 80 years. Exclusion Criteria: * History of neurological disorders affecting pelvic floor function (e.g., -Parkinson's disease, multiple sclerosis, CVA). * Adjuvant radiotherapy or androgen deprivation therapy. * Salvage prostatectomy. * Advanced tumor stage (cT4 or N+). * Prior pelvic surgery or radiation. * Cognitive impairment or physical inability to perform prescribed exercises .
References
Publications (0)
Data not yet available