Prostate Cancer (Post Prostatectomy)MPE-RPNCT07520916
The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy
A study testing Mobile-Based Perioperative Education Program and Standard Perioperative Care in people with Prostate Cancer (Post Prostatectomy) and Urinary Incontinence (UI), run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled study aims to evaluate the effect of mobile-based perioperative education on postoperative urinary incontinence and erectile function in patients undergoing radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy), Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Mobile-Based Perioperative Education Program and Standard Perioperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2026to 2 Apr 2027
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with prostate cancer and scheduled for elective radical prostatectomy (open, laparoscopic, or robotic)
- Aged 18 years or older
- Planned to undergo surgery at the study center(s)
- Able to use a smartphone and having sufficient digital literacy to operate the mobile application
- Provided written informed consent after being informed about the study
Who cannot join
- Pre-existing urinary incontinence or erectile dysfunction before surgery
- Severe cognitive impairment or severe visual or hearing impairment
- Previous pelvic radiotherapy or a history of major pelvic surgery
- Presence of severe comorbidity or terminal illness that may interfere with adherence to the study protocol
- Technological insufficiency preventing the use of the mobile application
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Giresun Prof. Dr. A. İlhan Özdemir State Hospital
Giresun, Giresun, 28000
ALKAY KARA, alkay@outlook.com.tr
About this study
Official title: The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy: A Randomized Controlled Trial
This prospective randomized controlled study aims to evaluate the effect of mobile-based perioperative education on postoperative urinary incontinence and erectile function in patients undergoing radical prostatectomy. Patients scheduled for radical prostatectomy will be assigned to either an intervention group or a control group. The intervention group will receive standard care plus a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education modules, reminders, and follow-up components. The control group will receive routine perioperative care and standard patient education. Data will be collected preoperatively, after urinary catheter removal, and at 1 month and 3 months after surgery. The primary outcomes are urinary incontinence and erectile function, assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the International Index of Erectile Function-5 (IIEF-5), and a 24-hour pad assessment. Secondary outcomes include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and system usability assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV)
Read the detailed description
Prostate cancer is one of the most common malignancies in men, and radical prostatectomy is a major curative treatment option for localized disease. However, urinary incontinence and erectile dysfunction remain among the most important postoperative complications affecting patients' functional recovery and quality of life. Access to structured perioperative education and rehabilitation may be limited because of time, cost, travel burden, and restricted access to specialized support. Mobile health-based interventions may provide an accessible and scalable approach for delivering perioperative education, exercise guidance, reminders, and follow-up support.
This study is designed to evaluate the effectiveness of a mobile-based perioperative education program for patients undergoing radical prostatectomy. Participants will be assigned to either an intervention group or a control group. The intervention group will receive routine perioperative care in addition to a structured mobile application-based program that includes video-assisted pelvic floor muscle training, perioperative education content, reminder notifications, and follow-up support. The control group will receive routine perioperative care and standard patient education.
Data will be collected at four time points: before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery. The primary outcomes of the study are postoperative urinary incontinence and erectile function. Urinary incontinence will be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a 24-hour pad assessment. Erectile function will be evaluated using the International Index of Erectile Function-5 (IIEF-5). Secondary outcomes will include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and usability of the mobile application assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV).
The findings of this study are expected to contribute to the development of accessible and structured perioperative care models for patients undergoing radical prostatectomy and to provide evidence on the effectiveness of mobile-based perioperative education in improving postoperative functional outcomes.
- Conditions
- Prostate Cancer (Post Prostatectomy), Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
- Being tested
- Mobile-Based Perioperative Education Program, Standard Perioperative Care
- Keywords
- Radical Prostatectomy, Mobile Health, mHealth, Perioperative Education, Pelvic Floor Muscle Training, Urinary Incontinence, Erectile Function
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-Based Perioperative Education ProgramBehavioural
A structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education content, reminder notifications, and follow-up support.
Standard Perioperative CareOther
Routine perioperative care and standard patient education provided according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-Based Perioperative Education | Experimental | Participants will receive routine perioperative care in addition to a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education content, reminders, and follow-up support. Receives: Behavioral: Mobile-Based Perioperative Education Program |
| Standard Perioperative Care | Active comparator | Participants will receive routine perioperative care and standard patient education. Receives: Other: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence Severity
Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Higher scores indicate greater symptom severity and greater impact on quality of life.
Measured: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Erectile Function
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.
Measured: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Urinary Leakage Severity by 24-Hour Pad Use
Urinary leakage severity will be evaluated according to 24-hour pad use. Daily use of 1 to 2 pads will be classified as mild, 3 to 5 pads as moderate, and more than 5 pads as severe urinary incontinence.
Measured: After urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Secondary outcomes (3)
Lower Urinary Tract Symptoms and Disease-Specific Quality of Life
Assessed using the International Prostate Symptom Score (IPSS), including symptom severity and the disease-specific quality of life item.
Measured: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Psychological Status
Assessed using the Depression Anxiety Stress Scale-21 (DASS-21).
Measured: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
System Usability
Usability of the mobile application will be assessed using the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV) to evaluate participants' ability to use the mobile application.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start2 Apr 2026
- Primary completion2 Apr 2027 (estimated)
- Study completion2 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in a 1:1 ratio to either the intervention group or the control group and followed over time at prespecified assessment points.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alkay Kara, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520916
- Sponsor's protocol ID
- RP-MOBILE-2026-01
- Other IDs
- 04.02.2026/11
- Acronym
- MPE-RP
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan has been established to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07520916
- Acronym / sponsor ID
- MPE-RP / RP-MOBILE-2026-01
- Conditions
- Prostate Cancer (Post Prostatectomy), Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
- Keywords
- Radical Prostatectomy, Mobile Health, mHealth, Perioperative Education, Pelvic Floor Muscle Training, Urinary Incontinence, Erectile Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 2 Apr 2027 (estimated)
- Study completion
- 2 Apr 2027 (estimated)
- First posted
- 9 Apr 2026 (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.
This prospective randomized controlled study aims to evaluate the effect of mobile-based perioperative education on postoperative urinary incontinence and erectile function in patients undergoing radical prostatectomy. Patients scheduled for radical prostatectomy will be assigned to either an intervention group or a control group. The intervention group will receive standard care plus a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education modules, reminders, and follow-up components. The control group will receive routine perioperative care and standard patient education. Data will be collected preoperatively, after urinary catheter removal, and at 1 month and 3 months after surgery. The primary outcomes are urinary incontinence and erectile function, assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the International Index of Erectile Function-5 (IIEF-5), and a 24-hour pad assessment. Secondary outcomes include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and system usability assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV)
Detailed description
Prostate cancer is one of the most common malignancies in men, and radical prostatectomy is a major curative treatment option for localized disease. However, urinary incontinence and erectile dysfunction remain among the most important postoperative complications affecting patients' functional recovery and quality of life. Access to structured perioperative education and rehabilitation may be limited because of time, cost, travel burden, and restricted access to specialized support. Mobile health-based interventions may provide an accessible and scalable approach for delivering perioperative education, exercise guidance, reminders, and follow-up support.
This study is designed to evaluate the effectiveness of a mobile-based perioperative education program for patients undergoing radical prostatectomy. Participants will be assigned to either an intervention group or a control group. The intervention group will receive routine perioperative care in addition to a structured mobile application-based program that includes video-assisted pelvic floor muscle training, perioperative education content, reminder notifications, and follow-up support. The control group will receive routine perioperative care and standard patient education.
Data will be collected at four time points: before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery. The primary outcomes of the study are postoperative urinary incontinence and erectile function. Urinary incontinence will be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a 24-hour pad assessment. Erectile function will be evaluated using the International Index of Erectile Function-5 (IIEF-5). Secondary outcomes will include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and usability of the mobile application assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV).
The findings of this study are expected to contribute to the development of accessible and structured perioperative care models for patients undergoing radical prostatectomy and to provide evidence on the effectiveness of mobile-based perioperative education in improving postoperative functional outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in a 1:1 ratio to either the intervention group or the control group and followed over time at prespecified assessment points.
| Arm | Type | Receives |
|---|---|---|
| Mobile-Based Perioperative Education | Experimental | Behavioral: Mobile-Based Perioperative Education ProgramParticipants will receive routine perioperative care in addition to a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education content, reminders, and follow-up support. |
| Standard Perioperative Care | Active comparator | Other: Standard Perioperative CareParticipants will receive routine perioperative care and standard patient education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with prostate cancer and scheduled for elective radical prostatectomy (open, laparoscopic, or robotic)
- Aged 18 years or older
- Planned to undergo surgery at the study center(s)
- Able to use a smartphone and having sufficient digital literacy to operate the mobile application
- Provided written informed consent after being informed about the study
Key exclusion criteria (5 listed)
- Pre-existing urinary incontinence or erectile dysfunction before surgery
- Severe cognitive impairment or severe visual or hearing impairment
- Previous pelvic radiotherapy or a history of major pelvic surgery
- Presence of severe comorbidity or terminal illness that may interfere with adherence to the study protocol
- Technological insufficiency preventing the use of the mobile application
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 |
|---|---|---|
| Mobile-Based Perioperative Education ProgramA structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education content, reminder notifications, and follow-up support. | Behavioural | Mobile-Based Perioperative Education |
| Standard Perioperative CareRoutine perioperative care and standard patient education provided according to institutional practice. | Other | Standard Perioperative Care |
Primary outcome
Urinary Incontinence Severity
Time frame: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Higher scores indicate greater symptom severity and greater impact on quality of life.
Erectile Function
Time frame: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.
Urinary Leakage Severity by 24-Hour Pad Use
Time frame: After urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Urinary leakage severity will be evaluated according to 24-hour pad use. Daily use of 1 to 2 pads will be classified as mild, 3 to 5 pads as moderate, and more than 5 pads as severe urinary incontinence.
3 secondary outcomes
Lower Urinary Tract Symptoms and Disease-Specific Quality of Life
Time frame: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
Psychological Status
Time frame: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
System Usability
Time frame: Before 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 9 Apr 2026.
- Individual participant dataSharing planned: No. No plan has been established to share individual participant data with other researchers.
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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 Mobile-Based Perioperative Education Program and Standard Perioperative Care in people with Prostate Cancer (Post Prostatectomy) and Urinary Incontinence (UI), run by Giresun University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 9 Apr 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 Turkey (Türkiye). 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 ALKAY KARA, PhD (+905394416497, alkay@outlook.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Incontinence Severity (time frame: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery). The study lists 3 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 9 Apr 2026.