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

NCT07520916 | Recruiting

• 2 other identifiers: RP-MOBILE-2026-0104.02.2026/11
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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)

Conditions

Prostate Cancer (Post Prostatectomy); Erectile Dysfunction Following Radical Prostatectomy; Urinary Incontinence (UI)

Keywords

Radical Prostatectomy; Mobile Health; mHealth; Perioperative Education; Pelvic Floor Muscle Training; Urinary Incontinence; Erectile Function

Outcome Measures

Primary Outcomes (3)

• 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.

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

• Erectile Function

  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

  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 Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Mobile-Based Perioperative Education Program

Standard Perioperative Care

ACTIVE COMPARATOR

Participants will receive routine perioperative care and standard patient education.

Other: Standard Perioperative Care

Interventions

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.

Mobile-Based Perioperative Education

Standard Perioperative Care OTHER

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

Standard Perioperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Prof. Dr. A. İlhan Özdemir State Hospital

Giresun, Giresun, 28000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ALKAY KARA, PhD

CONTACT

+905394416497; alkay@outlook.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 2, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)