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临床试验/NCT07520916
NCT07520916招募中不适用

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

Giresun University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2026年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
78
试验地点
1
主要终点
Urinary Incontinence Severity

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants and outcome assessors will be blinded to group assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Mobile-Based Perioperative Education Program (Behavioral)

Standard Perioperative Care

Active Comparator

Participants will receive routine perioperative care and standard patient education.

干预措施: Standard Perioperative Care (Other)

结局指标

主要结局

Urinary Incontinence Severity

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Psychological Status(Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery)
  • System Usability(Before surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alkay Kara

Assistant Professor, PhD

Giresun University

研究点 (1)

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