Efficacy of the Pelvic Clock® Device for Functional Recovery After Robotic-Assisted Radical Prostatectomy
NCT07333807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-01-12
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
Interventions
- DEVICE
-
Pelvic 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) .
- BEHAVIORAL
-
Standard 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 & Collaborators
-
Tri-Service General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2025-08-31
- Completion
- 2025-12-28
Countries
- Taiwan
Study Locations
More Related Trials
-
A Study of a Pelvic Floor Muscle Exercise Program Before and After Radical Prostatectomy
NCT06671782 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Pelvic Floor Muscles Training After Radical Prostatectomy.
NCT04172519 ·Status: UNKNOWN ·Phase: NA
-
Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
NCT05608746 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence
NCT03714984 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence
NCT02485665 ·Status: UNKNOWN ·Phase: NA
-
Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence
NCT01338584 ·Status: UNKNOWN ·Phase: NA
-
Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy
NCT00239824 ·Status: COMPLETED ·Phase: NA
-
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
NCT02352103 ·Status: COMPLETED ·Phase: PHASE3
-
Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial
NCT06915909 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy
NCT06200987 ·Status: RECRUITING ·Phase: NA
-
Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence
NCT05680168 ·Status: RECRUITING ·Phase: NA
-
Novel Robotic Prostatectomy Technique for Early Urinary Continence
NCT06237114 ·Status: COMPLETED
-
Intraoperative Nerve Monitoring During Robotic-assisted Radical Prostatectomy
NCT03721029 ·Status: COMPLETED ·Phase: NA
-
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
NCT00937833 ·Status: COMPLETED ·Phase: NA
-
Urinary Incontinence After Radical Prostatectomy
NCT05625048 ·Status: RECRUITING ·Phase: NA
-
Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies
NCT02114164 ·Status: COMPLETED ·Phase: NA
-
The Impact of Low Pressure Pneumo in RARP
NCT03370016 ·Status: COMPLETED ·Phase: NA
-
Prospective RCT on Post Prostatectomy Urine Leak
NCT02367404 ·Status: UNKNOWN ·Phase: PHASE3
-
Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP
NCT02812173 ·Status: COMPLETED ·Phase: NA
-
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
NCT05311267 ·Status: UNKNOWN ·Phase: NA
-
The Effect of Pelvic Floor Muscle Exercises After Radical Prostatectomy
NCT07045415 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Role of Levator Ani Muscle Reconstruction Technology in Urinary Incontinence Recovery
NCT06543420 ·Status: RECRUITING ·Phase: NA
-
Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy
NCT07172854 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
NCT04981834 ·Status: SUSPENDED ·Phase: NA
-
Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy
NCT02013011 ·Status: COMPLETED ·Phase: NA