The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorGiresun University

About this 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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mobile-Based Perioperative Education Program

    Behavioral

    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 Care

    Other intervention

    Routine perioperative care and standard patient education provided according to institutional practice.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Mobile-Based Perioperative EducationExperimental treatment 1 intervention
Group B: Standard Perioperative CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
2

Erectile Function

Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.

Time frame
Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
3

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.

Time frame
After urinary catheter removal, at 1 month after surgery, and at 3 months after surgery

Secondary outcomes

1

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.

Time frame
Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
2

Psychological Status

Assessed using the Depression Anxiety Stress Scale-21 (DASS-21).

Time frame
Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
3

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.

Time frame
Before surgery

Other outcomes

Sponsors and contacts

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