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

NCT07333807 | Completed DMC

• 1 other identifier: TSGH-B2025051PC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Radical Prostatectomy

Keywords

prostate cancer; Robotic-assisted radical prostatectomy; Pelvic Clock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Erectile Function (IIEF-5 Score)

  Baseline, 1, 3, and 6 months post-surgery

• Urinary Incontinence (24-hour Pad Weight)

  Baseline, 1, 3, and 6 months post-surgery

• Pelvic Floor Muscle Strength (Modified Oxford Scale)

  Baseline, 1, 3, and 6 months post-surgery

• Urinary Quality of Life (EPIC-Urinary Domain)

  Baseline, 1, 3, and 6 months post-surgery

• Postoperative Pain (VAS)

  Baseline, 1, 3, and 6 months post-surgery

Study Arms (2)

Experimental: Pelvic Clock Group

EXPERIMENTAL

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

Device: Pelvic Clock®

Active Comparator: Control Group

ACTIVE COMPARATOR

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

Behavioral: Standard Pelvic Floor Muscle Training (PFMT)

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) .

Experimental: Pelvic Clock Group

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

Active Comparator: Control Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with localized prostate cancer.
• Scheduled for Robotic-Assisted Radical Prostatectomy (RARP).
• Age between 55 and 80 years.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Neihu, 114, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: October 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 28, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)