A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy.

Purpose: Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy (RT). A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume (BV) and thus reduce the bladder-related organ motion. The secondary endpoints were to assess the incidence of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity for patients and patients' satisfaction with the bladder-filling instructions.

Methods And Materials: One hundred ten patients were randomly assigned to 1 of 2 bladder-filling protocols; 540 mL (3 cups) of water or 1080 mL (6 cups) of water, in a single institution trial. A portable ultrasound device, BladderScan BVI 6400 (Verathon Inc, Bothell, WA), measured BVs at treatment planning computed tomography (TPCT) scan and 3 times per week during RT. Maximum bladder dose and BV receiving ≥ 50, 60, and 70 Gy were recorded. Acute and late GU and GI toxicity were evaluated, as were patients' comfort, perception of urinary symptoms, and quality of life (QoL).

Results: There was significantly less BV variation in the 540 mL arm when compared with 1080 mL (median: 76 mL vs 105 mL, P = .003). Larger BVs on initial TPCT correlated with larger BV variations during RT (P < .0005). There were no statistically significant associations between arm and GU/GI toxicity, dose median comfort scores, or median QoL scores.

Conclusions: The 540 mL bladder-filling arm resulted in reproducible BVs throughout a course of RT, without any deterioration in QoL or increase in toxicities for prostate patients.