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

April 3, 2026 updated by: Alkay Kara, Giresun University

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile-Based Perioperative Education
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.
Behavioral: 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.
Active Comparator: Standard Perioperative Care
Participants will receive routine perioperative care and standard patient education.
Other: Standard Perioperative Care
Routine perioperative care and standard patient education provided according to institutional practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
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.
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
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.
After urinary catheter removal, at 1 month after surgery, and at 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed using the International Prostate Symptom Score (IPSS), including symptom severity and the disease-specific quality of life item.
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
Assessed using the Depression Anxiety Stress Scale-21 (DASS-21).
Before surgery, after urinary catheter removal, at 1 month after surgery, and at 3 months after surgery
System Usability
Time Frame: 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.
Before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

April 2, 2027

Study Completion (Estimated)

April 2, 2027

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-MOBILE-2026-01
  • 04.02.2026/11 (Other Identifier: Medical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan has been established to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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