Clinical trial · Interventional
A Reminder App to Optimize Bladder Filling in Patients with Prostate Cancer Receiving HYPO-fractionated Radiotherapy
A REminder App to Optimize Bladder FILLing in Patients with ProstAte Cancer Receiving HYPO-fractionated Radiotherapy
NCT06784115CI-TRIAL-00084888REFILLPAC-HYPOnot 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 treated with hypofractionated radiotherapy (HF-RT) for prostate cancer to drink water prior to each radiotherapy session on the number of bladder volumes \<200 ml during the HF-RT 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 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 the end of the radiotherapy course
- timeFrame
- through study completion, an average of 4 weeks
- description
- The primary endpoint is the number of radiation fractions with bladder volumes \<200 ml at the end of the radiotherapy course. The bladder volume at each radiation fraction is calculated from the corresponding Cone-Beam Computed Tomography (CBCT).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven prostate cancer 2. Indication for definitive HF-RT 3. Possession of and ability to use a smartphone 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 (0)
Data not yet available
No reference posted for this study.