Reminder App to Optimize Bladder Filling During Radiotherapy for Prostate Cancer

NCT06653751 | Not Yet Recruiting

• 1 other identifier: REFILL-PAC
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 5

Brief Summary

The primary goal of this study is to assess the impact of an app that reminds patients irradiated for high-risk prostate cancer to drink water prior to each radiotherapy session on the number of bladder volumes \<200 ml during the radiotherapy course and to demonstrate that this number is lower than without using an app (historical control group).

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Keywords

High-risk prostate cancer; Radiotherapy; Mobile application

Outcome Measures

Primary Outcomes (1)

• Number of fractions with bladder volumes <200 ml at 35 fractions

  The primary endpoint is the number of radiation fractions with bladder volumes \<200 ml after 35 fractions of radiotherapy. The bladder volume at each radiation fraction are calculated from the corresponding Cone-Beam Computed Tomography (CBCT).

  through study completion, an average of 7 weeks

Secondary Outcomes (3)

• Number of radiation fractions with bladder volumes <200 ml at the end of radiotherapy

  through study completion, an average of 8 weeks

• Rate of patient satisfaction with the reminder app

  through study completion, an average of 8 weeks

• Degree of the impact of the reminder app

  through study completion, an average of 4 weeks

Study Arms (1)

Support by a reminder app

EXPERIMENTAL

Patients are supported by a Reminder App. The purpose of the app is to remind patients irradiated for high-risk prostate cancer in an intuitive, unobtrusive and supportive way to drink 300 ml of water 45 minutes prior to each radiation session. This is supposed to have an impact on the number of bladder volumes \<200 ml. Bladder volumes \<200 ml were previously shown to be associated with increased urinary toxicity.

Device: Reminder App

Interventions

Reminder App DEVICE

The purpose of the app is to remind patients irradiated for prostate cancer in an intuitive, unobtrusive and supportive way to drink 300 ml of water 45 minutes prior to each radiation session.

Support by a reminder app

Eligibility Criteria

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

You may qualify if:

• Histologically proven high-risk prostate cancer
• Indication for definitive normo-fractionated radiotherapy
• Possession of a smart phone and the ability to use it
• Bladder volume at CT-simulation \<200 ml
• Male gender
• Age ≥18 years
• Written informed consent
• Capacity of the patient to contract

You may not qualify if:

• Radiotherapy of pelvic lymph nodes
• Expected non-compliance

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University of Southern Denmark: collaborator
• Medical School Hamburg: collaborator

Study Sites (5)

Vejle Hospital, University Hospital of Southern Denmark

Vejle, Southern Denmark, 7100, Denmark

Location

Medical Practice for Radiotherapy and Radiation Oncology

Hanover, Lower Saxony, 30161, Germany

Location

Medical School Hamburg, Schwerin Campus

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

Malteser Hospital St. Franziskus

Flensburg, Schleswig-Holstein, 24939, Germany

Location

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Related Publications (1)

• Rades D, Kuter JD, von Staden M, Al-Salool A, Janssen S, Timke C, Duma MN, Bartscht T, Vestergard Madsen C, Kristiansen C, Cremers F. A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial. JMIR Res Protoc. 2025 Apr 8;14:e68179. doi: 10.2196/68179.

  PMID: 40198906 DERIVED

Study Officials

• Dirk Rades, MD, FASTRO

  Department of Radiation Oncology, University of Lubeck, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Rades, Prof. Dr.

CONTACT

0049-451-500; dirk.rades@uksh.de

Carlos A. Narvaez-Wolf, Dr.

CONTACT

0049-451-500; Carlos.Narvaez-Wolf@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); DK (1)