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NCT Number: NCT07333807

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radical Prostatectomy Urogenital Diseases Urogenital Neoplasms

Age range

55 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Neihu, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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

Primary outcomes

  1. Trifecta Achievement Rate

    Time frame: 6 months post-surgery

    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)

Secondary outcomes

  1. Erectile Function (IIEF-5 Score)

    Time frame: Baseline, 1, 3, and 6 months post-surgery

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

  2. Urinary Incontinence (24-hour Pad Weight)

    Time frame: Baseline, 1, 3, and 6 months post-surgery

    Objective quantification of urinary leakage measured in grams.

  3. Pelvic Floor Muscle Strength (Modified Oxford Scale)

    Time frame: Baseline, 1, 3, and 6 months post-surgery

    Assessed via Digital Rectal Examination (DRE). Scores range from 0 (no contraction) to 5 (strong contraction).

  4. Urinary Quality of Life (EPIC-Urinary Domain)

    Time frame: Baseline, 1, 3, and 6 months post-surgery

    Expanded Prostate Cancer Index Composite - Urinary Domain. Scores range 0-100, higher scores indicate better QoL.

  5. Postoperative Pain (VAS)

    Time frame: Baseline, 1, 3, and 6 months post-surgery

    Visual Analog Scale. Scores range 0-10, lower scores indicate less pain.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

Efficacy of the Pelvic Clock® Device on Functional Recovery After Robotic-Assisted Radical Prostatectomy: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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