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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Pelvic Clock Group | Experimental | Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen. |
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| Active Comparator: Control Group | Active Comparator | Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) . |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function (IIEF-5 Score) | Assessed using the International Index of Erectile Function-5. Scores range from 5 to 25, with higher scores indicating better erectile function. | Baseline, 1, 3, and 6 months post-surgery |
| Urinary Incontinence (24-hour Pad Weight) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | Neihu | 114 | Taiwan |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
|
Objective quantification of urinary leakage measured in grams. |
| Baseline, 1, 3, and 6 months post-surgery |
| Pelvic Floor Muscle Strength (Modified Oxford Scale) | Assessed via Digital Rectal Examination (DRE). Scores range from 0 (no contraction) to 5 (strong contraction). | Baseline, 1, 3, and 6 months post-surgery |
| Urinary Quality of Life (EPIC-Urinary Domain) | Expanded Prostate Cancer Index Composite - Urinary Domain. Scores range 0-100, higher scores indicate better QoL. | Baseline, 1, 3, and 6 months post-surgery |
| Postoperative Pain (VAS) | Visual Analog Scale. Scores range 0-10, lower scores indicate less pain. | Baseline, 1, 3, and 6 months post-surgery |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |