Prostate Cancer (Post Prostatectomy), Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
Conditions
Keywords
Radical Prostatectomy, Mobile Health, mHealth, Perioperative Education, Pelvic Floor Muscle Training, Urinary Incontinence, Erectile Function
Brief 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. 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.
Interventions
BEHAVIORALMobile-Based Perioperative Education Program
A structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education content, reminder notifications, and follow-up support.
Routine perioperative care and standard patient education provided according to institutional practice.
Sponsors
Giresun University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to group assignment.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Incontinence Severity | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Urinary Tract Symptoms and Disease-Specific Quality of Life | Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery | Assessed using the International Prostate Symptom Score (IPSS), including symptom severity and the disease-specific quality of life item. |
| Psychological Status | Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery | Assessed using the Depression Anxiety Stress Scale-21 (DASS-21). |
| System Usability | Before surgery | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTALKAY KARA, PhD
Outcome results
None listed