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NCT Number: NCT06981026

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology clinic, University hospital Olomouc

Olomouc, 77900, Czechia

Location status: Recruiting

Location contact

Ondřej Česák, M.D.

CONTACT

[email protected]

+420 588 445 708

About this study

Participants in the intervention group will receive a comprehensive prehabilitation program starting 30 -14 days before surgery. They will be equipped with wearable devices (smartwatch and tablet/mobile phone) to monitor physical activity, including parameters like step count and heart rate, allowing for tailored exercise regimens focused on specific daily activity goals. These participants will also have access to educational videos and online consultations with physiotherapists for ongoing support. The program is designed to optimize physical readiness for surgery and improve postoperative recovery outcomes, with continuous monitoring and notifications provided to encourage adherence to the prescribed activities. The control group will receive printed educational materials with general preoperative exercise guidance. This group will have digital monitoring of physical activity, but patients will not receive any reminders or prompts to complete their exercises, they will not have access to online consultations. The primary endpoint of the study is the reduction of urinary incontinence as measured by the 24-hour pad test at 30 days before the surgery and 6 weeks, 3 and 6 months post-surgery. Secondary endpoints include assessments of physical fitness, quality of life, respiratory and postural function, and adherence to the rehabilitation protocol. Both groups will follow structured postoperative follow-ups with physiotherapists at defined intervals to monitor recovery progress and adjust the rehabilitation protocol as necessary. The study spans approximately 6 months for each participant, aiming to generate critical insights into the benefits of telemedicine in enhancing surgical recovery and improving patient outcomes in prostate cancer treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Reduction in Early Postoperative Incontinence

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

    Measured by the 24-hour pad weight test.

  2. Time to full Continence Recovery

    Time frame: 3 - 6 months post-surgery

    Time to achieve full continence following surgery (no pads)

  3. Six-Minute Walk Test Distance

    Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery

    Distance that a participant is able to walk in 6 minutes on a hard, flat surface.

    Unit of Measure: Meters

  4. Balance Test Composite Score

    Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery

    Score from a standardized balance assessment (Berg Balance Scale). Higher scores indicate better balance.

    Unit of Measure: Score Range: 0-56

  5. Lower Limb and abdominal Muscle Strength (Isometric)

    Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery

    Isometric strength of targeted muscle groups measured using dynamometer.

    Unit of Measure: Newtons (N)

Secondary outcomes

  1. EPIC-CP Total Score

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

    Patient-reported outcome measuring health-related QoL in domains relevant to prostate cancer, using the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher scores indicate worse QoL.

    Unit of Measure: Score (0-60)

  2. EQ-5D-5L Index Score

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

    EuroQol (Quality of Life)-5 Dimensions

    Health status measure based on five dimensions of functioning. Score derived using country-specific value sets. Higher scores represent better health status.

    Unit of Measure: Score (range: -0.59 to 1)

  3. Forced Expiratory Volume in One Second (FEV1)

    Time frame: 2 weeks pre-surgery, 3 and 6 months pos-surgery

    FEV1 represents the volume of air that can be forcibly exhaled in the first second of a forced breath. Measurements will be performed using calibrated spirometry according to ERS guidelines. FEV1 is a standard measure of pulmonary function. Higher values indicate better lung function.

    Unit of Measure: Liters

  4. Maximal Voluntary Ventilation (MVV)

    Time frame: 2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery

    MVV is the maximum amount of air a participant can inhale and exhale within a specific time frame (12 seconds), extrapolated to one minute. Testing will be conducted using standard spirometry under ERS guidelines. MVV reflects respiratory muscle endurance and ventilatory capacity.

    Unit of Measure: Liters/minute

  5. Daily Step Count

    Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery

    Average number of steps recorded per day using a wearable device.

    Unit of Measure: Steps/day

  6. Daily Physical Activity Duration

    Time frame: 2 weeks pre-surgery, 3 and 6 months post-surgery

    Average duration of physical activity (e.g., moderate to vigorous activity) recorded per day using wearable device.

    Unit of Measure: Minutes/day

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Bastlová, Ph.D.

CONTACT

[email protected]

+420 588 442 628

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Mobilní fyzioterapie s.r.o.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 20, 2025
Registry last updated
Jul 27, 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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