Trial Information

A Randomised Trial Comparing The Bladder Volume Consistency Achieved With Two Bladder-Filling Protocols in Prostate Conformal Radiotherapy

OBJECTIVES:

Primary

- To compare the consistency in bladder volumes in patients with prostate cancer
undergoing conformal radiotherapy, when randomized to one of two sets of
bladder-filling instructions.

Secondary

- To compare the incidence of acute and late genitourinary and gastrointestinal toxicity
in patients treated with these methods.

- To determine patient satisfaction with the bladder-filling instructions.

- To determine satisfaction of bladder-filling protocols amongst radiation therapists and
doctors.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: 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.

- Arm II: 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.

In both arms, patients follow their bladder filling instructions and then undergo conformal
radiation therapy daily for about 8 weeks.

Patients' perception of symptoms, quality of life, and urinary symptoms are assessed
periodically by the International Prostate Symptom Score (I-PSS). Patients' satisfaction
with the bladder-filling instructions (i.e., ability to comply with the bladder-filling
protocol, the number of incidents of wetting accidents, number of incidents of having to
repeat the water drinking on the same day due to machine breakdown or the patient's
inability to retain the full bladder for the required amount of time, and the level of
frustration) is assessed periodically by the Visual Analogue Scale (VAS).

Staff satisfaction with bladder-filling interventions (i.e., patient compliance with the
protocols, acceptance of bladder dose-volume histograms [DVHs], need for re-scan with a
fuller bladder, amount of disruption to the therapist's work schedule, number of incidents
of wetting accidents, number of incidents of having to repeat the water drinking on the same
day due to machine breakdown or the patient's inability to retain the full bladder for the
required amount of time, and the level of satisfaction or frustration) is assessed
periodically.

After completion of study treatment, patients are followed up periodically for 4 years.