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Peer-reviewedCC BY 4.0Journal of Clinical Medicine

Impact of a Reminder App on Bladder Filling During Moderately Hypo-Fractionated Radiotherapy for Prostate Cancer: Results of the REFILL-PAC-HYPO Trial

  • Dirk Rades1,2
  • Stefan Janssen1,3
  • Laura Doehring2
  • Jan-Dirk Küter2
  • Michael von Staden2
  • Ahmed Al-Salool2
  • Julia Koeck4
  • Justus Domschikowski4
  • Christian Felix Schulz5
  • Jon Cacicedo6,7
  • Christine Vestergård Madsen8
  • Charlotte Kristiansen8
8 affiliations
  1. 1Department of Radiation Oncology, University of Luebeck, 23562 Luebeck, Germany
  2. 2Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Luebeck Campus, 23538 Luebeck, Germany
  3. 3Medical Practice for Radiotherapy Rundestrasse, 30161 Hannover, Germany
  4. 4Department of Radiotherapy, Malteser Hospital St. Franziskus, 24939 Flensburg, Germany
  5. 5Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Kiel Campus, 24105 Kiel, Germany
  6. 6Department of Radiation Oncology, Cruces University Hospital, 48903 Barakaldo, Spain
  7. 7Department of Radiation Oncology, Biobizkaia Health Research Institute, 48903 Barakaldo, Spain
  8. 8Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark
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Abstract

Background/Objectives: Moderate hypo-fractionation is frequently used for irradiation of prostate cancer. Irrespective of dose fractionation, radiotherapy can lead to radiation cystitis. To reduce urinary toxicity, it is important to avoid bladder volumes < 200 mL. This may be facilitated with an app reminding patients to drink water prior to irradiation. This non-randomized multicenter REFILL-PAC-HYPO trial with external control evaluated the association between use of the reminder app and bladder filling during a radiotherapy course. Methods: Twenty-two patients receiving hypo-fractionated irradiation (20 × 3.0 Gy) were planned to be supported by the app (the prospective experimental group) and compared to 95 patients who were not supported by the app (the historical control group). The primary endpoint was the number of fractions with a bladder volume < 200 mL. Secondary objectives included satisfaction with the app and its impact on using health technology. Results: The median number of fractions with a bladder volume < 200 mL was lower in the app-supported experimental group (13; interquartile range: 6, 18 vs. 19; interquartile range: 14, 20). The Wilcoxon–Mann–Whitney test indicated a significant between-group difference (p = 0.0009) with a Hodges–Lehmann estimate of −4 fractions (95% confidence interval: −7 to −2). Supportive analyses used a multivariable negative binomial model (rate ratio: 0.71; p = 0.0018) and propensity score analysis (p = 0.012). The dissatisfaction rate was 20%; 78.9% of patients stated at least a little impact of trial participation on the use of health technology. Conclusions: Given the limitations of this study, the app was associated with fewer fractions with a bladder volume < 200 mL in this cohort. Although patient dissatisfaction was considered acceptable, further optimization of the app would be welcomed. Moreover, the findings of this study require confirmation in a randomized trial that also considers urinary toxicity.

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Cite

BibTeXRIS
BibTeX
@article{rades2026impact,
  title = {{Impact of a Reminder App on Bladder Filling During Moderately Hypo-Fractionated Radiotherapy for Prostate Cancer: Results of the REFILL-PAC-HYPO Trial}},
  author = {Dirk Rades and Stefan Janssen and Laura Doehring and Jan-Dirk Küter and Michael von Staden and Ahmed Al-Salool and Julia Koeck and Justus Domschikowski and Christian Felix Schulz and Jon Cacicedo and Christine Vestergård Madsen and Charlotte Kristiansen},
  journal = {Journal of Clinical Medicine},
  year = {2026},
  month = nov,
  doi = {10.3390/jcm15218559},
  url = {https://www.mdpi.com/2077-0383/15/21/8559},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Impact of a Reminder App on Bladder Filling During Moderately Hypo-Fractionated Radiotherapy for Prostate Cancer: Results of the REFILL-PAC-HYPO Trial
AU  - Dirk Rades
AU  - Stefan Janssen
AU  - Laura Doehring
AU  - Jan-Dirk Küter
AU  - Michael von Staden
AU  - Ahmed Al-Salool
AU  - Julia Koeck
AU  - Justus Domschikowski
AU  - Christian Felix Schulz
AU  - Jon Cacicedo
AU  - Christine Vestergård Madsen
AU  - Charlotte Kristiansen
PY  - 2026
DA  - 2026/11/03
JO  - Journal of Clinical Medicine
DO  - 10.3390/jcm15218559
UR  - https://www.mdpi.com/2077-0383/15/21/8559
AB  - Background/Objectives: Moderate hypo-fractionation is frequently used for irradiation of prostate cancer. Irrespective of dose fractionation, radiotherapy can lead to radiation cystitis. To reduce urinary toxicity, it is important to avoid bladder volumes < 200 mL. This may be facilitated with an app reminding patients to drink water prior to irradiation. This non-randomized multicenter REFILL-PAC-HYPO trial with external control evaluated the association between use of the reminder app and bladder filling during a radiotherapy course. Methods: Twenty-two patients receiving hypo-fractionated irradiation (20 × 3.0 Gy) were planned to be supported by the app (the prospective experimental group) and compared to 95 patients who were not supported by the app (the historical control group). The primary endpoint was the number of fractions with a bladder volume < 200 mL. Secondary objectives included satisfaction with the app and its impact on using health technology. Results: The median number of fractions with a bladder volume < 200 mL was lower in the app-supported experimental group (13; interquartile range: 6, 18 vs. 19; interquartile range: 14, 20). The Wilcoxon–Mann–Whitney test indicated a significant between-group difference (p = 0.0009) with a Hodges–Lehmann estimate of −4 fractions (95% confidence interval: −7 to −2). Supportive analyses used a multivariable negative binomial model (rate ratio: 0.71; p = 0.0018) and propensity score analysis (p = 0.012). The dissatisfaction rate was 20%; 78.9% of patients stated at least a little impact of trial participation on the use of health technology. Conclusions: Given the limitations of this study, the app was associated with fewer fractions with a bladder volume < 200 mL in this cohort. Although patient dissatisfaction was considered acceptable, further optimization of the app would be welcomed. Moreover, the findings of this study require confirmation in a randomized trial that also considers urinary toxicity.
SN  - 2077-0383
ER  -