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<IndexPatientGuideline ID="x22915" Name="Guideline Statement 50" IsComponent="true" Changed="20260428T16:38:51" Created="20260428T16:29:19" Published="20260506T19:42:12" SiteBaseUrl="https://www.auanet.org" Locale="" XPowerPath="/Home/Guidelines &amp; Quality/Guidelines/Clinical Guidelines/BPH Guideline/Procedural Technologies/Intraprostatic Drug Coated Balloon/Guideline Statement 50">
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  <Header type="string" UID="faf9fd2842b549d09e761cd943c2be20" label="Header" readonly="false" hidden="false" required="false" indexable="false" CIID="">Guideline Statement 50</Header>
  <BodyCopy type="xhtml" UID="41a2d8598c364193bbfe9ad86d7bcd3c" label="Body Copy" readonly="false" hidden="false" required="false" indexable="false" Height="" CIID="">&lt;p&gt;&lt;strong&gt;Clinicians may offer IPDCB as an option for patients with prostates 20-80 cc, a prostatic urethral length 32-55 mm, and without an obstructing median lobe for the treatment of LUTS/BPH. (&lt;em&gt;Conditional Recommendation; Evidence Level: Grade C&lt;/em&gt;)&lt;/strong&gt;&lt;/p&gt;</BodyCopy>
  <DiscussionLinkName type="string" UID="b364402056154f78b38cd8d663eaf3ba" label="Discussion Link Name" readonly="false" hidden="false" required="false" indexable="false" CIID="">Discussion</DiscussionLinkName>
  <DiscussionTitle type="string" UID="ceedafe4ad314b5d8d3225bc0083b81c" label="Discussion Title" readonly="false" hidden="false" required="false" indexable="false" CIID="">Discussion</DiscussionTitle>
  <DiscussionBody type="xhtml" UID="9bbbac02721d4eefba59c63ee7ff9007" label="Discussion Body" readonly="false" hidden="false" required="false" indexable="false" Height="" CIID="">&lt;p&gt;Established under outpatient sedation, but possible under local anesthetic, the IPDCB is a treatment validated in 20-80 cc prostates having a 32-55 mm prostatic urethral length, without a median lobe. It is a two-stage procedure, first utilizing a temporary dilating balloon to fracture the anterior prostatic commissure, and then exchanging this for a second paclitaxel-coated balloon that deposits the drug at the targeted tissues, which is selected from one of four sizes according to patient anatomy.&lt;sup&gt;385&lt;/sup&gt; The treatment is contraindicated in the setting of paclitaxel hypersensitivity and patients are advised to abstain from sexual activity or utilize a condom for 30 days after treatment to minimize drug exposure to their partners (&lt;a href="https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210020B.pdf"&gt;https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210020B.pdf&lt;/a&gt;). As paclitaxel can persist in the semen for up to 12 months after the procedure, it is also recommended to avoid conceiving for at least 1 year after treatment.&lt;/p&gt;
&lt;p&gt;Compared to sham, IPDCB provided significantly greater improvement in IPSS from 3-12 months, with no significant differences in sexual function.&lt;sup&gt;385&lt;/sup&gt; Improvements from baseline IPSS and quality of life scores as well as objective measures of uroflowmetry and PVR bladder volume appear stable through two years of non-controlled observation.&lt;sup&gt;386&lt;/sup&gt; Long-term durability remains unknown; however, similar non-controlled observational studies at 3-4 years have demonstrated a 1.3% surgical retreatment rate with some worsening of IPSS and quality of life scores, as well as objective measures of uroflowmetry and PVR bladder volume.&lt;sup&gt;387&lt;/sup&gt;&lt;sup&gt; &lt;/sup&gt;&lt;/p&gt;</DiscussionBody>
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