{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T21:38:42Z","timestamp":1790199522683,"version":"4.1.0"},"reference-count":34,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec id=\"ab-zoi250042-4\"><jats:title>Importance<\/jats:title><jats:p>The polyethylene glycol-based hydrogel spacer (PHS) system temporarily separates the rectum from the prostate in patients undergoing radiotherapy (RT) for prostate cancer (PCa).<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi250042-5\"><jats:title>Objective<\/jats:title><jats:p>To compare incidence of bowel disorders and related procedures in patients receiving RT with and without PHS.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi250042-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>This retrospective cohort study used 4 datasets: Medicare 5% Standard Analytic Files, Medicare 100% Standard Analytic Files, Merative MarketScan Commercial Database, and Premier Healthcare Database. Participants included adult patients with PCa undergoing RT from 2015 to 2021.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi250042-7\"><jats:title>Exposure<\/jats:title><jats:p>Placement of PHS.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi250042-8\"><jats:title>Main Outcomes<\/jats:title><jats:p>All-cause bowel disorders and related procedures, identified from diagnosis and procedure codes. Results were compared with age-matched male general population without PCa or RT.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi250042-9\"><jats:title>Results<\/jats:title><jats:p>Of 261\u202f906 patients with PCa included in the study, 25\u202f167 (9.6%) received PHS (mean [SD] age, 70.7 [6.5] years) and 236\u202f739 did not (mean [SD] age, 71.1 [7.5] years). One year prior to RT, patients who received PHS had a lower mean (SD) Charlson Comorbidity Index score than those who did not (2.48 [1.08] vs 3.14 [1.95]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001). Stereotactic RT was more common in patients who received PHS (2743 [10.9%] vs 8810 [3.7%]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001), while intensity-modulated RT was less common (12\u202f755 [50.7%] vs 142\u202f402 [60.2%]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001). After 4 years post RT, patients who received PHS had a 25% lower hazard of bowel disorders (hazard ratio [HR], 0.75 [95% CI, 0.72-0.78]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001) and a 46% lower hazard of related procedures (HR, 0.54 [95% CI, 0.47-0.62]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001) than patients who did not receive PHS. Patients without PHS had higher hazard compared with an age-matched general population (disorders: 17.1% [95% CI, 17.3%-17.6%] vs 10.3% [95% CI, 10.1%-10.5%]; HR, 1.35 [95% CI, 1.32-1.37]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001; procedures: 2.0% [95% CI, 1.9%-2.1%] vs 0.7% [95% CI, 0.7%-0.8%]; HR, 1.92 [95% CI, 1.79-2.06]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001), while patients who received PHS did not (disorders: 12.4% vs 10.3%; HR, 1.00 [95% CI, 0.98-1.05]; <jats:italic>P<\/jats:italic>\u2009=\u2009.82; procedures: 1.1% [95% CI, 1.0%-1.3%] vs 0.7% [95% CI, 0.7%-0.8%]; HR, 1.11 [95% CI, 0.96-1.29]; <jats:italic>P<\/jats:italic>\u2009=\u2009.15). Common procedures included colonoscopy, sigmoidoscopy, and rectal resection.<\/jats:p><\/jats:sec><jats:sec id=\"ab-zoi250042-10\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>In this cohort study of patients with PCa receiving RT, those receiving a PHS had a significantly lower incidence of all-cause bowel disorders and related procedures compared with patients who did not receive a PHS over the 4-year follow-up. The incidence among patients with PHS was similar to the general population. These findings are consistent with prior phase 3 trial results, where patients receiving PHS experienced no decline in bowel quality of life.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2025.0491","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T15:11:50Z","timestamp":1741705910000},"page":"e250491","source":"Crossref","is-referenced-by-count":7,"title":["Bowel Disorder Incidence and Rectal Spacer Use in Patients With Prostate Cancer Undergoing Radiotherapy"],"prefix":"10.1001","volume":"8","author":[{"given":"Michael R.","family":"Folkert","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, University of Washington School of Medicine, Seattle"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryoko","family":"Sato","sequence":"additional","affiliation":[{"name":"Boston Scientific, Marlborough, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James B.","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Dartmouth Hitchcock Medical Center, Hanover, New Hampshire"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"Vannan","sequence":"additional","affiliation":[{"name":"Boston Scientific, Marlborough, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Bhattacharyya","sequence":"additional","affiliation":[{"name":"Boston Scientific, Marlborough, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carrie","family":"Noriega","sequence":"additional","affiliation":[{"name":"Boston Scientific, Marlborough, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel A.","family":"Hamstra","sequence":"additional","affiliation":[{"name":"Radiation Oncology, Baylor College of Medicine, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2025,3,11]]},"reference":[{"issue":"1","key":"zoi250042r2","doi-asserted-by":"publisher","first-page":"12","DOI":"10.3322\/caac.21820","article-title":"Cancer statistics, 2024.","volume":"74","author":"Siegel","year":"2024","journal-title":"CA Cancer J Clin"},{"issue":"32","key":"zoi250042r3","doi-asserted-by":"publisher","first-page":"3251","DOI":"10.1200\/JCO.18.00606","article-title":"Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an American Urological Association\/American Society for Radiation Oncology\/Society of Urologic Oncology Guideline.","volume":"36","author":"Bekelman","year":"2018","journal-title":"J Clin Oncol"},{"issue":"10","key":"zoi250042r4","doi-asserted-by":"publisher","first-page":"1067","DOI":"10.6004\/jnccn.2023.0050","article-title":"Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology.","volume":"21","author":"Schaeffer","year":"2023","journal-title":"J Natl Compr Canc Netw"},{"issue":"12","key":"zoi250042r5","doi-asserted-by":"publisher","first-page":"4026","DOI":"10.1245\/s10434-014-3780-9","article-title":"A competing risk analysis of cancer-specific mortality of initial treatment with radical prostatectomy versus radiation therapy in clinically localized high-risk prostate cancer.","volume":"21","author":"Lee","year":"2014","journal-title":"Ann Surg Oncol"},{"issue":"4","key":"zoi250042r6","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1016\/j.clgc.2014.01.010","article-title":"Radical prostatectomy or radiotherapy in high-risk prostate cancer: a systematic review and metaanalysis.","volume":"12","author":"Petrelli","year":"2014","journal-title":"Clin Genitourin Cancer"},{"key":"zoi250042r7","doi-asserted-by":"publisher","first-page":"g1502","DOI":"10.1136\/bmj.g1502","article-title":"Comparative effectiveness of radical prostatectomy and radiotherapy in prostate cancer: observational study of mortality outcomes.","volume":"348","author":"Sooriakumaran","year":"2014","journal-title":"BMJ"},{"issue":"1","key":"zoi250042r8","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1016\/j.eururo.2015.11.010","article-title":"Surgery versus radiotherapy for clinically-localized prostate cancer: a systematic review and meta-analysis.","volume":"70","author":"Wallis","year":"2016","journal-title":"Eur Urol"},{"issue":"11","key":"zoi250042r9","doi-asserted-by":"publisher","first-page":"1531","DOI":"10.1016\/S1470-2045(19)30569-8","article-title":"Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial.","volume":"20","author":"Brand","year":"2019","journal-title":"Lancet Oncol"},{"issue":"8","key":"zoi250042r10","doi-asserted-by":"publisher","first-page":"1047","DOI":"10.1016\/S1470-2045(16)30102-4","article-title":"Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.","volume":"17","author":"Dearnaley","year":"2016","journal-title":"Lancet Oncol"},{"issue":"1","key":"zoi250042r11","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1016\/j.eururo.2011.09.027","article-title":"Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature.","volume":"61","author":"Bud\u00e4us","year":"2012","journal-title":"Eur Urol"},{"issue":"3","key":"zoi250042r12","doi-asserted-by":"publisher","first-page":"S59","DOI":"10.1016\/j.urology.2013.08.036","article-title":"SIU\/ICUD consultation on Urethral Strictures: posterior urethral stenosis after treatment of prostate cancer.","volume":"83","author":"Herschorn","year":"2014","journal-title":"Urology"},{"issue":"5","key":"zoi250042r13","doi-asserted-by":"publisher","first-page":"309","DOI":"10.4111\/icu.2016.57.5.309","article-title":"Urethral strictures after radiation therapy for prostate cancer.","volume":"57","author":"Moltzahn","year":"2016","journal-title":"Investig Clin Urol"},{"key":"zoi250042r14","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/6829875","article-title":"Prostate cancer radiation therapy: what do clinicians have to know?","volume":"2016","author":"Vanneste","year":"2016","journal-title":"Biomed Res Int"},{"issue":"3","key":"zoi250042r15","doi-asserted-by":"publisher","first-page":"S116","DOI":"10.1016\/j.ijrobp.2009.02.090","article-title":"Radiation dose-volume effects of the urinary bladder.","volume":"76","author":"Viswanathan","year":"2010","journal-title":"Int J Radiat Oncol Biol Phys"},{"issue":"10","key":"zoi250042r16","doi-asserted-by":"publisher","first-page":"2411","DOI":"10.1007\/s00345-022-04124-x","article-title":"Incidence of genitourinary complications following radiation therapy for localised prostate cancer.","volume":"40","author":"David","year":"2022","journal-title":"World J Urol"},{"issue":"8","key":"zoi250042r17","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1016\/j.clon.2013.05.003","article-title":"Biological dose escalation and hypofractionation: what is there to be gained and how will it best be done?","volume":"25","author":"Tree","year":"2013","journal-title":"Clin Oncol (R Coll Radiol)"},{"issue":"6","key":"zoi250042r18","doi-asserted-by":"publisher","first-page":"189","DOI":"10.5306\/wjco.v6.i6.189","article-title":"Current role of spacers for prostate cancer radiotherapy.","volume":"6","author":"Pinkawa","year":"2015","journal-title":"World J Clin Oncol"},{"key":"zoi250042r19","doi-asserted-by":"publisher","first-page":"e74","DOI":"10.1016\/j.urology.2021.05.013","article-title":"SpaceOAR hydrogel spacer for reducing radiation toxicity during radiotherapy for prostate cancer. a systematic review.","volume":"156","author":"Armstrong","year":"2021","journal-title":"Urology"},{"issue":"5","key":"zoi250042r20","doi-asserted-by":"publisher","first-page":"976","DOI":"10.1016\/j.ijrobp.2016.12.024","article-title":"Continued benefit to rectal separation for prostate radiation therapy: final results of a phase III trial.","volume":"97","author":"Hamstra","year":"2017","journal-title":"Int J Radiat Oncol Biol Phys"},{"issue":"5","key":"zoi250042r21","doi-asserted-by":"publisher","first-page":"971","DOI":"10.1016\/j.ijrobp.2015.04.030","article-title":"Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy.","volume":"92","author":"Mariados","year":"2015","journal-title":"Int J Radiat Oncol Biol Phys"},{"issue":"6","key":"zoi250042r22","doi-asserted-by":"publisher","first-page":"e208221","DOI":"10.1001\/jamanetworkopen.2020.8221","article-title":"Association of the placement of a perirectal hydrogel spacer with the clinical outcomes of men receiving radiotherapy for prostate cancer: a systematic review and meta-analysis.","volume":"3","author":"Miller","year":"2020","journal-title":"JAMA Netw Open"},{"issue":"3","key":"zoi250042r23","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1111\/bju.15097","article-title":"Long-term follow-up after radiotherapy for prostate cancer with and without rectal hydrogel spacer: a pooled prospective evaluation of bowel-associated quality of life.","volume":"126","author":"Seymour","year":"2020","journal-title":"BJU Int"},{"issue":"18","key":"zoi250042r24","doi-asserted-by":"publisher","first-page":"1823","DOI":"10.1200\/JCO.2017.75.5371","article-title":"Comparative toxicities and cost of intensity-modulated radiotherapy, proton radiation, and stereotactic body radiotherapy among younger men with prostate cancer.","volume":"36","author":"Pan","year":"2018","journal-title":"J Clin Oncol"},{"issue":"5","key":"zoi250042r25","doi-asserted-by":"publisher","first-page":"373","DOI":"10.1016\/0021-9681(87)90171-8","article-title":"A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.","volume":"40","author":"Charlson","year":"1987","journal-title":"J Chronic Dis"},{"key":"zoi250042r26","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2023.1239104","article-title":"A pooled long-term follow-up after radiotherapy for prostate cancer with and without a rectal hydrogel spacer: impact of hydrogel on decline in sexual quality of life.","volume":"13","author":"Seymour","year":"2023","journal-title":"Front Oncol"},{"issue":"1152","key":"zoi250042r27","doi-asserted-by":"publisher","DOI":"10.1259\/bjr.20220947","article-title":"SpaceOAR hydrogel distribution and early complications in patients undergoing radiation therapy for prostate cancer.","volume":"96","author":"Yates","year":"2023","journal-title":"Br J Radiol"},{"issue":"4","key":"zoi250042r28","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1111\/iju.15140","article-title":"Safety of hydrogel spacers for rectal wall protection in patients with prostate cancer: A retrospective analysis of 200 consecutive cases.","volume":"30","author":"Yamaguchi","year":"2023","journal-title":"Int J Urol"},{"issue":"10","key":"zoi250042r29","doi-asserted-by":"publisher","first-page":"868","DOI":"10.1089\/end.2019.0431","article-title":"Major complications and adverse events related to the injection of the SpaceOAR hydrogel system before radiotherapy for prostate cancer: review of the manufacturer and user facility device experience database.","volume":"33","author":"Aminsharifi","year":"2019","journal-title":"J Endourol"},{"issue":"12","key":"zoi250042r30","article-title":"Perineal Abscess Following SpaceOAR Insertion.","volume":"15","author":"Azhar","year":"2023","journal-title":"Cureus"},{"key":"zoi250042r31","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1016\/j.urology.2023.09.016","article-title":"Real-world complications of the SpaceOAR hydrogel spacer: a review of the manufacturer and user facility device experience database.","volume":"183","author":"Fernandez","year":"2024","journal-title":"Urology"},{"issue":"4","key":"zoi250042r32","doi-asserted-by":"publisher","DOI":"10.1016\/j.adro.2021.100713","article-title":"Hydrogel spacer rectal wall infiltration associated with severe rectal injury and related complications after dose intensified prostate cancer stereotactic ablative radiation therapy.","volume":"6","author":"McLaughlin","year":"2021","journal-title":"Adv Radiat Oncol"},{"key":"zoi250042r33","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2023.12.034","article-title":"Major complications and adverse events related to use of SpaceOAR hydrogel for prostate cancer radiotherapy.","author":"Millot","year":"2024","journal-title":"Urology"},{"key":"zoi250042r34","doi-asserted-by":"publisher","DOI":"10.1016\/j.eucr.2024.102870","article-title":"Anaphylactic shock during SpaceOAR Vue hydrogel procedure.","volume":"57","author":"Nesi","year":"2024","journal-title":"Urol Case Rep"},{"key":"zoi250042r1","unstructured":"American Cancer Society. Key statistics for prostate cancer. 2024; Accessed May 17, 2024. https:\/\/www.cancer.org\/cancer\/types\/prostate-cancer\/about\/key-statistics.html"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2831218\/folkert_2025_oi_250042_1741025138.3631.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T15:11:53Z","timestamp":1741705913000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2831218"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,11]]},"references-count":34,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3,3]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2025.0491","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,11]]}}}