NCT07333807

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: Male
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Functional recovery, specifically urinary continence and erectile potency, remains a major challenge following RARP. Standard PFMT is often limited by poor patient compliance and incorrect muscle isolation. The Pelvic Clock® device is designed to enhance proprioception and facilitate multi-directional control of pelvic floor muscles. Participants undergoing RARP were randomized 1:1 to either the intervention group (Pelvic Clock + Standard PFMT) or the control group (Standard PFMT alone). Functional outcomes, including incontinence (pad weight), erectile function (IIEF-5), and muscle strength (Oxford scale), were assessed at baseline, 1, 3, and 6 months postoperatively.

Conditions

• Prostate Cancer
• Radical Prostatectomy

Interventions

Type	Name	Description
DEVICE	Pelvic Clock®	Participants used the device for neuromuscular re-education. Protocol: Frequency: 2 sessions per day. Duration: 5-10 minutes per session. Schedule: Minimum 5 days/week. Repetitions: 10-20 repetitions for specific movements (e.g., 12-6 o'clock tilt, 3-9 o'clock tilt). Participants also adhered to the standard PFMT regimen (3-4 sets/day) .
BEHAVIORAL	Standard Pelvic Floor Muscle Training (PFMT)	Standard Kegel exercises without assistive devices. Frequency: 3-4 sets per day. Intensity: Sustain each contraction for 5-10 seconds, followed by 5-10 seconds relaxation. Repetitions: 10-15 repetitions per set

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-08-31
• Completion: 2025-12-28
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Taiwan