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<IndexPatientGuideline ID="x22913" Name="Guideline Statement 49" IsComponent="true" Changed="20260428T16:32:48" Created="20260428T16:28:30" Published="20260506T19:42:11" SiteBaseUrl="https://www.auanet.org" Locale="" XPowerPath="/Home/Guidelines &amp; Quality/Guidelines/Clinical Guidelines/BPH Guideline/Procedural Technologies/Temporary Implantable Prostate Device/Guideline Statement 49">
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  <Header type="string" UID="faf9fd2842b549d09e761cd943c2be20" label="Header" readonly="false" hidden="false" required="false" indexable="false" CIID="">Guideline Statement 49</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 TIPD as an option for patients with prostates 25-75 cc without an obstructing median lobe for the treatment of LUTS/BPH. (&lt;em&gt;Expert Opinion&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;TIPD is a device placed by transurethral approach into the bladder and pulled back into the prostate fossa. The implant is composed of nitinol and comes in a preloaded delivery device that can be introduced through a scope. It has 3 struts at the 5, 7, and 12 o&amp;rsquo;clock positions and an anchoring leaflet that helps keep it in place once in the prostate fossa. Once delivered, the struts exert pressure to reshape the prostate and bladder neck. It is removed five to seven days after placement via a specialized urethral catheter that compresses the device for removal. The procedure may be performed in the office or operating room using local anesthesia and/or sedation.&lt;/p&gt;
&lt;p&gt;In an RCT, TIPD was compared to a sham procedure across 16 sites in the U.S. and Canada enrolling a total of 185 men (128 to TIPD and 57 to sham).&lt;sup&gt;256&lt;/sup&gt; Prostate volumes were restricted to 25-75 cc and the absence of an &amp;ldquo;obstructive median lobe&amp;rdquo; was an inclusion criterion. The primary study endpoint was the percentage of patients achieving a reduction of at least three points in IPSS at three months. Unblinding occurred at 3 months, although responder analysis was carried out to 12 months. An improvement in the IPSS of at least 3 points post-procedure was reported in 78.6% of the TIPD group and 60.0% of the sham group (P=0.03). Mean change in IPSS at 3 months was 9.0 points in the TIPD group and 6.6 points in the sham group, which was not statistically different between groups (p=0.06). The responder analysis (defined as IPSS improvement of &amp;ge;7 points) was performed at 12 months and demonstrated a responder rate of 72.6% in the TIPD group compared to 50% in the sham group (p=0.048). There were few related serious adverse events but more overall adverse events, within the first 30 days, in the TIPD group than the sham group (38.1% versus 17.5%). Mean scores for the IIEF and the Sexual Health Inventory for Males (SHIM) did not differ significantly from the patient baseline to three months.&lt;sup&gt;256, 382&lt;/sup&gt;&lt;/p&gt;
&lt;p&gt;A prospective, multicenter, international study has also evaluated TIPD without a sham comparator. Only 50 of the initial 81 patients at 3 sites were still in the study after 36 months and 41 patients at &amp;gt;48 months.&lt;sup&gt;383&lt;/sup&gt; IPSS improved by 45% compared to baseline values when evaluated at &amp;gt;48 months after procedures with 2 of 50 patients requiring BPH-specific procedural retreatment in the first 36 months.&lt;/p&gt;
&lt;p&gt;TIPD has been compared to PUL in a non-randomized study;&lt;sup&gt;384&lt;/sup&gt; however, no study has compared TIPD to TURP directly at this time.&amp;nbsp;&lt;/p&gt;</DiscussionBody>
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