The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy

NCT06981026 | Not Yet Recruiting

• 2 other identifiers: OP JAK ITI VZ 2CZ.02.01.01/00/23_021/0008829
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study titled " The effectiveness of telemedicine monitoring prehabilitation in prostate cancer patients undergoing radical prostatectomy " investigates the impact of a structured telemedicine-supported prehabilitation and rehabilitation program on reducing postoperative urinary incontinence in patients with localized prostate cancer. Radical prostatectomy, a common treatment for localized prostate cancer, is often associated with complications such as urinary incontinence, which significantly affects quality of life. This study aims to address this issue by enhancing patients' physical conditioning and adherence to pre- and postoperative rehabilitation through the use of wearable devices and remote physiotherapy consultations.

Conditions

Prostatectomy; Prehabilitation; Telemedicine

Keywords

Prostatectomy; Physiotherapy; Telemedicine; eHealth; Oncology; Prehabilitation; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Reduction in Early Postoperative Incontinence

  Measured by the 24-hour pad weight test.

  Baseline evaluated at 30 days before surgery. Evaluated at 6 weeks, 3 months, and 6 months post-surgery.

• Time to full Continence Recovery

  Time to achieve full continence following surgery (no pads)

  3 - 6 months post-surgery

• Six-Minute Walk Test Distance

  Distance that a participant is able to walk in 6 minutes on a hard, flat surface. Unit of Measure: Meters

  2 weeks pre-surgery, 3 months and 6 months post-surgery

• Balance Test Composite Score

  Score from a standardized balance assessment (Berg Balance Scale). Higher scores indicate better balance. Unit of Measure: Score Range: 0-56

  2 weeks pre-surgery, 3 months and 6 months post-surgery

• Lower Limb and abdominal Muscle Strength (Isometric)

  Isometric strength of targeted muscle groups measured using dynamometer. Unit of Measure: Newtons (N)

  2 weeks pre-surgery, 3 months and 6 months post-surgery

Secondary Outcomes (6)

• EPIC-CP Total Score

  Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery

• EQ-5D-5L Index Score

  Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery

• Forced Expiratory Volume in One Second (FEV1)

  2 weeks pre-surgery, 3 and 6 months pos-surgery

• Maximal Voluntary Ventilation (MVV)

  2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery

• Daily Step Count

  2 weeks pre-surgery, 3 months and 6 months post-surgery

Study Arms (2)

Telemedicine-Supported Prehabilitation and Rehabilitation

EXPERIMENTAL

Preoperative Phase: Wearable Technology: Smartwatch monitoring steps, heart rate, and activity. Physical Exam \& Physiotherapy Session: Musculoskeletal evaluation, pelvic floor training via sonographic feedback, posture/respiratory exercises (2-4 weeks pre-surgery). Activity Guidelines: Specific daily step targets and exercises to optimize surgical readiness. Educational Support: Videos demonstrating pelvic floor training, posture, breathing, and exercises. Remote Monitoring \& Notifications: Continuous monitoring with inactivity alerts/reminders. Online Consultations: Virtual physiotherapy sessions for feedback and plan adjustments. Postoperative Phase: Physiotherapy Visits: At 3, 4, 6 weeks; 3, 6 months post-surgery for assessment and rehab adjustments. Telemonitoring: Continued wearable monitoring, video consultations, and access to educational videos. Data Collection: Objective wearable data collected to track progress, adherence, and personalize rehab.

Other: Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.

Control Group (Standard Preoperative and Postoperative Care)

NO INTERVENTION

Preoperative Phase: Wearable Technology: Participants receive wearable devices (smartwatch, tablet or phone) for real-time monitoring of physical activity parameters (step count, heart rate, general activity). Physical Exam \& Physiotherapy: Physiotherapist evaluates musculoskeletal function, provides verbal education on pelvic floor muscle activity, posture, and respiratory exercises; scheduled 2-4 weeks pre-surgery. Printed Educational Material: Participants receive printed booklets containing general information, exercises, and activity guidelines to prepare for surgery. Telemonitoring (No Notifications): Activity digitally monitored, without sending reminders or prompts for exercise adherence. Postoperative Phase: Physiotherapy Visits: Scheduled at 3 weeks, 4 weeks, 6 weeks, 3 months, and 6 months post-surgery for progress assessment and rehabilitation adjustments. Data Collection: Continuous collection of objective data from wearable devices compared to intervention group.

Interventions

Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools. OTHER

A combination of wearable technology, activity guidelines, educational support, remote monitoring with notifications and consultations with physiotherapists.

Telemedicine-Supported Prehabilitation and Rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-confirmed localized prostate cancer (ICD code C.61).
• Indicated for radical prostatectomy, with or without pelvic lymphadenectomy (ePLND).
• Not previously treated for prostate cancer, including radiation therapy to the pelvis, major pelvic surgery, or placement of a penile implant or artificial urinary sphincter.
• No known urethral stricture or colostomy or chronic urinary catheterization.
• No medical or current psychiatric disorders that precludes their participation in the study.
• Status of the musculoskeletal system allowing physical exercise.
• Urinary continent at baseline.
• Has reliable internet and the skills/knowledge to use technologies use for the study.

You may not qualify if:

• Other malignant tumors, except for benign skin carcinoma.
• Active treatment for other oncological diagnoses.
• Presence of preoperative urinary incontinence.
• Diagnosed mental or cognitive disorders.
• Prior pelvic radiotherapy or hormone therapy for prostate cancer recurrence.
• Severe musculoskeletal disorders preventing active exercise
• Inability to use required technologies

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Mobilní fyzioterapie s.r.o.: collaborator

Study Sites (1)

Urology clinic, University hospital Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Respiratory Rate

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Petra Bastlová, Ph.D.

CONTACT

+420 588 442 628; Petra.Bastlova@fnol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CZ (1)