Efficacy of the Pelvic Clock® Device for Functional Recovery After Robotic-Assisted Radical Prostatectomy

Tri-Service General Hospital60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Prostate Cancer Radical Prostatectomy

Interventions

Pelvic Clock®DEVICE

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) .

Standard Pelvic Floor Muscle Training (PFMT)BEHAVIORAL

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

Eligibility

Sex: MALEMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 .

Locations (1)

Tri-Service General Hospital

Taipei, Neihu, Taiwan

Outcomes

Primary Outcomes

Trifecta Achievement Rate

Composite outcome defined as the simultaneous fulfillment of: (1) Cancer control (PSA \< 0.2 ng/mL); (2) Urinary continence (0 pads/day); and (3) Potency (ability to achieve erection sufficient for intercourse)

Time frame: 6 months post-surgery

Secondary Outcomes

Erectile Function (IIEF-5 Score)

Assessed using the International Index of Erectile Function-5. Scores range from 5 to 25, with higher scores indicating better erectile function.