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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Radical Prostatectomy
• Intervention / Treatment: Device: Pelvic Clock®; Behavioral: Standard Pelvic Floor Muscle Training (PFMT)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Neihu
    • Taipei, Neihu, Taiwan, 114
      • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Pelvic Clock Group; Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen.	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) .
Active Comparator: Active Comparator: Control Group; Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1, 3, and 6 months post-surgery
Urinary Incontinence (24-hour Pad Weight)	Objective quantification of urinary leakage measured in grams.	Baseline, 1, 3, and 6 months post-surgery
Pelvic Floor Muscle Strength (Modified Oxford Scale)	Assessed via Digital Rectal Examination (DRE). Scores range from 0 (no contraction) to 5 (strong contraction).	Baseline, 1, 3, and 6 months post-surgery
Urinary Quality of Life (EPIC-Urinary Domain)	Expanded Prostate Cancer Index Composite - Urinary Domain. Scores range 0-100, higher scores indicate better QoL.	Baseline, 1, 3, and 6 months post-surgery
Postoperative Pain (VAS)	Visual Analog Scale. Scores range 0-10, lower scores indicate less pain.	Baseline, 1, 3, and 6 months post-surgery

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): December 28, 2025

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; Robotic-assisted radical prostatectomy; Pelvic Clock
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: TSGH-B2025051PC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No