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

Официальное название

The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy: A Randomized Controlled Trial

Обзор

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)

Подробное описание

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.

Вмешательства

• Поведенческое Mobile-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.
• Другое Standard Perioperative Care
  Routine perioperative care and standard patient education provided according to institutional practice.

Первичные конечные точки

• Urinary Incontinence Severity [Срок оценки: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery]
• Erectile Function [Срок оценки: 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 [Срок оценки: After urinary catheter removal, at 1 month after surgery, and at 3 months after surgery]

Вторичные конечные точки (3)

• Lower Urinary Tract Symptoms and Disease-Specific Quality of Life [Срок оценки: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery]
• Psychological Status [Срок оценки: Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery]
• System Usability [Срок оценки: Before surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Giresun Prof. Dr. A. İlhan Özdemir State Hospital — Giresun

Идентификаторы

NCT: NCT07520916 · RP-MOBILE-2026-01 · 04.02.2026/11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗