Prostate Cancer, Radical Prostatectomy
Conditions
Keywords
prostate cancer, Robotic-assisted radical prostatectomy, Pelvic Clock
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.
Interventions
DEVICEPelvic 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) .
BEHAVIORALStandard 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
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
55 Years to 80 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trifecta Achievement Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Erectile Function (IIEF-5 Score) | 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. |
| Urinary Incontinence (24-hour Pad Weight) | Baseline, 1, 3, and 6 months post-surgery | Objective quantification of urinary leakage measured in grams. |
| Pelvic Floor Muscle Strength (Modified Oxford Scale) | Baseline, 1, 3, and 6 months post-surgery | Assessed via Digital Rectal Examination (DRE). Scores range from 0 (no contraction) to 5 (strong contraction). |
| Urinary Quality of Life (EPIC-Urinary Domain) | Baseline, 1, 3, and 6 months post-surgery | Expanded Prostate Cancer Index Composite - Urinary Domain. Scores range 0-100, higher scores indicate better QoL. |
| Postoperative Pain (VAS) | Baseline, 1, 3, and 6 months post-surgery | Visual Analog Scale. Scores range 0-10, lower scores indicate less pain. |
Countries
Taiwan
Outcome results
None listed