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

Tri-Service General Hospital

Status: Completed

Conditions: Radical Prostatectomy; Prostate Cancer

Treatments: Device: Pelvic Clock®; Behavioral: Standard Pelvic Floor Muscle Training (PFMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07333807

TSGH-B2025051PC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental: Pelvic Clock Group

Experimental group

Description:

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

Treatment:

Device: Pelvic Clock®

Active Comparator: Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Pelvic Floor Muscle Training (PFMT)