Clinical trial · Interventional
Comparing Two Sets of Bladder-Filling Instructions in Treating Patients Undergoing Radiation Therapy For Prostate Cancer. ICORG 05-04
A Randomised Trial Comparing The Bladder Volume Consistency Achieved With Two Bladder-Filling Protocols in Prostate Conformal Radiotherapy
- 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)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Having a full bladder may improve the effectiveness of radiation therapy to the bladder. It is not yet known which set of bladder-filling instructions is more effective in helping patients keep their bladder full during radiation therapy. PURPOSE: This randomized clinical trial is comparing two sets of bladder-filling instructions in treating patients with prostate cancer undergoing radiation therapy.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pre-procedural preparation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients empty their bladders and consume 6 cups of water 30 minutes before undergoing radiotherapy. Patients also undergo bladder volume measurements using a bladder volume instrument (BVI) periodically during treatment.
- interventionNames
- Procedure: pre-procedural preparation
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients empty their bladders and consume 3 cups of water 30 minutes before undergoing radiotherapy. Patients also undergo bladder volume measurements using a BVI periodically during treatment.
- interventionNames
- Procedure: pre-procedural preparation
Primary outcomes (1)
- measure
- Consistency of bladder volumes
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of prostate cancer * Undergoing a radical course of radiotherapy * Planned treatment in the supine position PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * No history of urinary incontinence or urinary catheterization * No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research/medical team that the patient may not be able to comply with the protocol * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No previous surgery for urinary conditions, except transurethral resection of the prostate (TURP) * Prior transrectal ultrasound (TRUS) allowed
References
Publications (0)
Data not yet available