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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-80
SponsorUniversity Hospital Olomouc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Other malignant tumors, except for benign skin carcinoma.

Active treatment for other oncological diagnoses.

Presence of preoperative urinary incontinence.

Diagnosed mental or cognitive disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Telemedicine-Supported Prehabilitation and RehabilitationExperimental treatment 1 intervention
Group B: Control Group (Standard Preoperative and Postoperative Care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reduction in Early Postoperative Incontinence

Measured by the 24-hour pad weight test.

Time frame
Baseline evaluated at 30 days before surgery. Evaluated at 6 weeks, 3 months, and 6 months post-surgery.
2

Time to full Continence Recovery

Time to achieve full continence following surgery (no pads)

Time frame
3 - 6 months post-surgery
3

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

Time frame
2 weeks pre-surgery, 3 months and 6 months post-surgery
4

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

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

Secondary outcomes

1

EPIC-CP Total Score

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)

Time frame
Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
2

EQ-5D-5L Index Score

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)

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

Forced Expiratory Volume in One Second (FEV1)

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

Time frame
2 weeks pre-surgery, 3 and 6 months pos-surgery
4

Maximal Voluntary Ventilation (MVV)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Olomouc

Lead sponsor

Mobilní fyzioterapie s.r.o.

Collaborator