ProstatectomyNCT06981026
The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy
A study testing Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools. in people with Prostatectomy and Prehabilitation, run by University Hospital Olomouc at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostatectomy, Prehabilitation, Telemedicine
- What is being tested?
- Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Urology clinic, University hospital Olomouc
Olomouc, 77900
Ondřej Česák, M.D., +420 588 445 708, Ondrej.Cesak@fnol.cz
About this study
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.
Read the detailed description
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.
- Conditions
- Prostatectomy, Prehabilitation, Telemedicine
- Being tested
- Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.
- Keywords
- Prostatectomy, Physiotherapy, Telemedicine, eHealth, Oncology, Prehabilitation, Rehabilitation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Early Postoperative Incontinence
Measured by the 24-hour pad weight test.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Secondary outcomes (6)
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)
Measured: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
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)
Measured: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
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
Measured: 2 weeks pre-surgery, 3 and 6 months pos-surgery
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
Measured: 2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery
Daily Step Count
Average number of steps recorded per day using a wearable device.
Unit of Measure: Steps/day
Measured: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Daily Physical Activity Duration
Average duration of physical activity (e.g., moderate to vigorous activity) recorded per day using wearable device.
Unit of Measure: Minutes/day
Measured: 2 weeks pre-surgery, 3 and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Mobilní fyzioterapie s.r.o.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981026
- Sponsor's protocol ID
- OP JAK ITI VZ 2
- Other IDs
- CZ.02.01.01/00/23_021/0008829
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06981026
- Acronym / sponsor ID
- OP JAK ITI VZ 2
- Conditions
- Prostatectomy, Prehabilitation, Telemedicine
- Keywords
- Prostatectomy, Physiotherapy, Telemedicine, eHealth, Oncology, Prehabilitation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Mobilní fyzioterapie s.r.o.
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine-Supported Prehabilitation and Rehabilitation | Experimental | Other: Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.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. |
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.A combination of wearable technology, activity guidelines, educational support, remote monitoring with notifications and consultations with physiotherapists. | Other | Telemedicine-Supported Prehabilitation and Rehabilitation |
Primary outcome
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.
Time to full Continence Recovery
Time frame: 3 - 6 months post-surgery
Time to achieve full continence following surgery (no pads)
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
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
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)
6 secondary outcomes
EPIC-CP Total Score
Time frame: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
EQ-5D-5L Index Score
Time frame: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
Forced Expiratory Volume in One Second (FEV1)
Time frame: 2 weeks pre-surgery, 3 and 6 months pos-surgery
Maximal Voluntary Ventilation (MVV)
Time frame: 2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery
Daily Step Count
Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Daily Physical Activity Duration
Time frame: 2 weeks pre-surgery, 3 and 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools. in people with Prostatectomy and Prehabilitation, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Bastlová, Ph.D. (+420 588 442 628, Petra.Bastlova@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.