Clinical trial · Interventional
Reminder App to Optimize Bladder Filling During Radiotherapy for Prostate Cancer
A REminder App to Optimize Bladder FILLing During Radiotherapy of Patients With Prostate CAncer
NCT06653751CI-TRIAL-00091224REFILL-PACnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Patients Treated by Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reminder App | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Support by a reminder app
- description
- 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.
- interventionNames
- Device: Reminder App
Primary outcomes (1)
- measure
- Number of fractions with bladder volumes <200 ml at 35 fractions
- timeFrame
- through study completion, an average of 7 weeks
- description
- 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).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven high-risk prostate cancer 2. Indication for definitive normo-fractionated radiotherapy 3. Possession of a smart phone and the ability to use it 4. Bladder volume at CT-simulation \<200 ml 5. Male gender 6. Age ≥18 years 7. Written informed consent 8. Capacity of the patient to contract Exclusion Criteria: 1. Radiotherapy of pelvic lymph nodes 2. Expected non-compliance
References
Publications (1)
- DERIVEDRades 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