Clinical trial · Interventional
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
A Pilot Study Using a Digital Behavioral Intervention With a Smart Water Bottle to Improve Bladder Filling Compliance in Prostate Cancer Patients Undergoing Radiation Therapy
NCT04946214CI-TRIAL-00061157HIDRATEPROcompletedN/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 purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.
Conditions
Conditions (3)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smart Water Bottle | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Smart Water Bottle Intervention Arm
- description
- Patients will receive a smart water bottle, then instructed on bowel and bladder preparation for daily standard of care radiotherapy treatments for up to 10 weeks.
- interventionNames
- Behavioral: Smart Water Bottle
Primary outcomes (1)
- measure
- Proportion of participants who did not continue to use the intervention through the study.
- timeFrame
- Up to 10 weeks
- description
- Proportion of participants will be reported as those who did not continue to use the intervention throughout the study.
Secondary outcomes (6)
- measure
- Proportion of non-compliant participants as measured by survey
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age older than 17 but less than 81. * Non-metastatic prostate cancer patients undergoing definitive radiation treatment. * Patients that self-identify as "smartphone owners". * Patients with either iPhone (iOS 13.0 or higher) or Android (version 5.0.1 or higher) based smartphone access. * English or Spanish speaking patients. Exclusion Criteria: * Patients with any history of pre-existing urinary retention. * Patients with any history of kidney, urothelial tract or bladder cancer. * Post-operative prostate patients. * Patients that plan to be treated with pelvic lymph node radiation coverage. * Patients without a functional bladder. * Patients with a history of prior pelvic surgery or penile augmentation (circumcision is okay). * Patients who have previously received any form of pelvic radiation. * Patients unable to give informed consent. * Patients who refuse to drink room-temperature water used for bladder filling. * Patients without functional vision. * Patients who are colorblind. * Patient who refuse to use the smartphone app or who refuse consent.
References
Publications (1)
- DERIVEDJin W, Montoya C, Rich BJ, Taswell CS, Noy M, Kwon D, Spieler B, Mahal B, Abramowitz M, Yechieli R, Pollack A, Dal Pra A. A Smart Water Bottle and Companion App (HidrateSpark 3) to Improve Bladder-Filling Compliance in Patients With Prostate Cancer Receiving Radiotherapy: Nonrandomized Trial of Feasibility and Acceptability. JMIR Cancer. 2024 Sep 10;10:e51061. doi: 10.2196/51061. PMID 39255484