title: A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy.
abstract: OBJECTIVE
  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
  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.
authors.affiliation: Discipline of Radiation Therapy, School of Medicine, Trinity College Dublin, Ireland. Electronic address: laura.mullaney@tcd.ie.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Mullaney
authors.affiliation: Department of Radiation Oncology, Saint Luke's Radiation Oncology Network, St Luke's Hospital, Dublin, Ireland.
authors.forename: Evelyn
authors.initials: E
authors.lastname: O'Shea
authors.affiliation: Clinical Trials Resource Unit, St Luke's Hospital, Dublin, Ireland.
authors.forename: Mary T
authors.initials: MT
authors.lastname: Dunne
authors.affiliation: Clinical Trials Resource Unit, St Luke's Hospital, Dublin, Ireland.
authors.forename: Marie A
authors.initials: MA
authors.lastname: Finn
authors.affiliation: Department of Radiation Oncology, Saint Luke's Radiation Oncology Network, St Luke's Hospital, Dublin, Ireland.
authors.forename: Pierre G
authors.initials: PG
authors.lastname: Thirion
authors.affiliation: Department of Radiation Oncology, Saint Luke's Radiation Oncology Network, St Luke's Hospital, Dublin, Ireland.
authors.forename: Lesley Ann
authors.initials: LA
authors.lastname: Cleary
authors.affiliation: Department of Radiation Oncology, Saint Luke's Radiation Oncology Network, St Luke's Hospital, Dublin, Ireland.
authors.forename: Maeve
authors.initials: M
authors.lastname: McGarry
authors.affiliation: Department of Radiation Oncology, Saint Luke's Radiation Oncology Network, St James' Hospital, Dublin, Ireland.
authors.forename: Louise
authors.initials: L
authors.lastname: O'Neill
authors.affiliation: Department of Radiation Oncology, Saint Luke's Radiation Oncology Network, St Luke's Hospital, Dublin, Ireland.
authors.forename: John G
authors.initials: JG
authors.lastname: Armstrong
mesh_terms: D000208:Acute Disease; D000368:Aged; D019583:Dose Fractionation, Radiation; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000209:etiology* / Q000473:pathology; D006801:Humans; D008297:Male; D052801:Male Urogenital Diseases / Q000209:etiology* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000150:complications / Q000473:pathology / Q000532:radiotherapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000209:etiology* / Q000473:pathology; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects*; D001743:Urinary Bladder / Q000473:pathology* / Q000528:radiation effects