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

NCT ID: NCT07333807

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental: Pelvic Clock Group

Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen.

Group Type: EXPERIMENTAL

Pelvic Clock®

Intervention Type: 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) .

Active Comparator: Control Group

Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT).

Group Type: ACTIVE_COMPARATOR

Standard Pelvic Floor Muscle Training (PFMT)

Intervention Type: 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

Interventions

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) .

Intervention Type: DEVICE

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 .

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

MING-HSIN, YANG

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tri-Service General Hospital

Taipei, Neihu, Taiwan

Countries

Taiwan

Other Identifiers

TSGH-B2025051PC

Identifier Type: -

Identifier Source: org_study_id