A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial
BackgroundMany patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increa...
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JMIR Publications
2025-04-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e68179 |
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| author | Dirk Rades Jan-Dirk Küter Michael von Staden Ahmed Al-Salool Stefan Janssen Carmen Timke Marciana Nona Duma Tobias Bartscht Christine Vestergård Madsen Charlotte Kristiansen Florian Cremers |
| author_facet | Dirk Rades Jan-Dirk Küter Michael von Staden Ahmed Al-Salool Stefan Janssen Carmen Timke Marciana Nona Duma Tobias Bartscht Christine Vestergård Madsen Charlotte Kristiansen Florian Cremers |
| author_sort | Dirk Rades |
| collection | DOAJ |
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BackgroundMany patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increased urinary toxicity. Therefore, it is important to maintain bladder volumes greater than 200 ml during as many radiation fractions as possible. Several studies investigated drinking protocols, where patients were asked to drink a certain amount of water prior to radiotherapy sessions. This may require considerable discipline from the patients, who are predominantly older adults. Adherence to a drinking protocol may be facilitated by a mobile app that reminds patients to drink water prior to each radiation session. This study investigates the effect of such an app on bladder filling status in patients with prostate cancer undergoing external beam radiotherapy (EBRT) alone.
ObjectiveThe primary goal of this study is to evaluate the impact of an app that reminds patients irradiated for prostate cancer to drink 300 ml of water prior to each radiotherapy session on the number of fractions with bladder volumes <200 ml during the radiotherapy course.
MethodsThis ongoing phase 2 aims to recruit 28 patients treated with EBRT alone for nonmetastatic prostate cancer. Radiotherapy will be administered using normo-fractionation, with doses ranging from 70 to 80 Gy in 35 to 40 fractions of 2 Gy, preferably with volumetric-modulated arc therapy (VMAT). Treatment volumes include the prostate with or without the seminal vesicles.
ResultsRecruitment for this trial will start in March 2025 and is planned to be completed in October 2026. The study is scheduled to conclude in December 2026.
ConclusionsThis trial is the first to evaluate the impact of a reminder app on the number of radiotherapy fractions with bladder volumes <200 ml in patients undergoing irradiation for localized prostate cancer.
Trial RegistrationClinicaltrials.gov NCT06653751; https://clinicaltrials.gov/show/NCT06653751
International Registered Report Identifier (IRRID)PRR1-10.2196/68179 |
| format | Article |
| id | doaj-art-82f1a81f147d416dabc3288aaefb6f4a |
| institution | OA Journals |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | JMIR Publications |
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| spelling | doaj-art-82f1a81f147d416dabc3288aaefb6f4a2025-08-20T02:08:54ZengJMIR PublicationsJMIR Research Protocols1929-07482025-04-0114e6817910.2196/68179A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective TrialDirk Radeshttps://orcid.org/0009-0008-2046-4968Jan-Dirk Küterhttps://orcid.org/0009-0002-0424-6916Michael von Stadenhttps://orcid.org/0009-0008-3950-7075Ahmed Al-Saloolhttps://orcid.org/0009-0003-7601-7204Stefan Janssenhttps://orcid.org/0000-0003-1802-4767Carmen Timkehttps://orcid.org/0000-0003-0256-6625Marciana Nona Dumahttps://orcid.org/0000-0002-0205-4411Tobias Bartschthttps://orcid.org/0009-0002-6149-465XChristine Vestergård Madsenhttps://orcid.org/0000-0002-8314-3888Charlotte Kristiansenhttps://orcid.org/0000-0002-8073-5781Florian Cremershttps://orcid.org/0009-0001-3411-1476 BackgroundMany patients with nonmetastatic prostate cancer receive radiotherapy, which may be associated with acute cystitis, particularly if the volume of the urinary bladder is small. Three studies showed bladder volumes <200 ml or <180 ml to be associated with increased urinary toxicity. Therefore, it is important to maintain bladder volumes greater than 200 ml during as many radiation fractions as possible. Several studies investigated drinking protocols, where patients were asked to drink a certain amount of water prior to radiotherapy sessions. This may require considerable discipline from the patients, who are predominantly older adults. Adherence to a drinking protocol may be facilitated by a mobile app that reminds patients to drink water prior to each radiation session. This study investigates the effect of such an app on bladder filling status in patients with prostate cancer undergoing external beam radiotherapy (EBRT) alone. ObjectiveThe primary goal of this study is to evaluate the impact of an app that reminds patients irradiated for prostate cancer to drink 300 ml of water prior to each radiotherapy session on the number of fractions with bladder volumes <200 ml during the radiotherapy course. MethodsThis ongoing phase 2 aims to recruit 28 patients treated with EBRT alone for nonmetastatic prostate cancer. Radiotherapy will be administered using normo-fractionation, with doses ranging from 70 to 80 Gy in 35 to 40 fractions of 2 Gy, preferably with volumetric-modulated arc therapy (VMAT). Treatment volumes include the prostate with or without the seminal vesicles. ResultsRecruitment for this trial will start in March 2025 and is planned to be completed in October 2026. The study is scheduled to conclude in December 2026. ConclusionsThis trial is the first to evaluate the impact of a reminder app on the number of radiotherapy fractions with bladder volumes <200 ml in patients undergoing irradiation for localized prostate cancer. Trial RegistrationClinicaltrials.gov NCT06653751; https://clinicaltrials.gov/show/NCT06653751 International Registered Report Identifier (IRRID)PRR1-10.2196/68179https://www.researchprotocols.org/2025/1/e68179 |
| spellingShingle | Dirk Rades Jan-Dirk Küter Michael von Staden Ahmed Al-Salool Stefan Janssen Carmen Timke Marciana Nona Duma Tobias Bartscht Christine Vestergård Madsen Charlotte Kristiansen Florian Cremers A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial JMIR Research Protocols |
| title | A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial |
| title_full | A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial |
| title_fullStr | A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial |
| title_full_unstemmed | A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial |
| title_short | A Reminder App to Optimize Bladder Filling During Radiotherapy for Patients With Prostate Cancer (REFILL-PAC): Protocol for a Prospective Trial |
| title_sort | reminder app to optimize bladder filling during radiotherapy for patients with prostate cancer refill pac protocol for a prospective trial |
| url | https://www.researchprotocols.org/2025/1/e68179 |
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