Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time : findings from three studies
Identifieur interne : 008C57 ( Main/Repository ); précédent : 008C56; suivant : 008C58Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time : findings from three studies
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Abstract
OBJECTIVE To validate the Sexual Assessment Monitor (SAM), a novel apparatus designed to collect electronic data on ejaculatory latency time (ELT) for diagnosing premature ejaculation (PE), and for accurately measuring treatment outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS Men with PE, and healthy volunteers aged 18-75 years, were enrolled in three open-label studies, conducted in the UK. The SAM, which consists of a control box with two front attachments, a vibrator and sensor, was attached to the penis. The vibrator, which provides stimulation, was positioned at the frenulum using a soft cuff; the vibrator intensity was set at 80 units for most subjects. The sensor is an indium-gallium elasticated loop, which was positioned around the base of the penis to detect ejaculatory pulses. These pulses were transmitted to a data recorder in the control box. The data, which are displayed graphically as traces, were automatically classified by a computer-generated algorithm to quantify ELT. RESULTS In all, 53 healthy volunteers and 58 men with PE provided 213 and 195 evaluable records, respectively. Most were complete records (99% and 96%). The pooled data showed that the ELT was much higher for healthy volunteers than for men with PE (geometric means: 687 vs 169 s, respectively), with a healthy volunteer to PE patient ratio of 2.87 (P< 0.001). Only 6.3% of subjects reported mild adverse events, which were unrelated to the SAM. CONCLUSIONS These open-label studies show that the SAM can consistently and safely measure times to erection (from the start of vibration) and ejaculation, and ELT in healthy volunteers and men with PE. These findings show that the SAM has the potential to become the 'gold standard' in the diagnosis of PE and in clinical trials design.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time : findings from three studies</title><author><name sortKey="Dinsmore, Wallace W" uniqKey="Dinsmore W">Wallace W. Dinsmore</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Royal Victoria Hospital</s1><s2>Belfast</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Royal Victoria Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Ralph, David J" uniqKey="Ralph D">David J. Ralph</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Hospital of St Johns and St Elizabeth's</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Kell, Phillip" uniqKey="Kell P">Phillip Kell</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Porterbrook Clinic</s1><s2>Sheffield</s2><s3>GBR</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Porterbrook Clinic</wicri:noRegion></affiliation></author><author><name sortKey="Wylie, Kevan R" uniqKey="Wylie K">Kevan R. Wylie</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Porterbrook Clinic</s1><s2>Sheffield</s2><s3>GBR</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Porterbrook Clinic</wicri:noRegion></affiliation></author><author><name sortKey="Dean, John P" uniqKey="Dean J">John P. Dean</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>The Salisbury Clinic</s1><s2>Plymouth</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>The Salisbury Clinic</wicri:noRegion></affiliation></author><author><name sortKey="Novak, Claire" uniqKey="Novak C">Claire Novak</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Plethora Solutions Ltd</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Wyllie, Jennifer S" uniqKey="Wyllie J">Jennifer S. Wyllie</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Plethora Solutions Ltd</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Wyllie, Michael G" uniqKey="Wyllie M">Michael G. Wyllie</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Plethora Solutions Ltd</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="inist">06-0445352</idno><date when="2006">2006</date><idno type="stanalyst">PASCAL 06-0445352 INIST</idno><idno type="RBID">Pascal:06-0445352</idno><idno type="wicri:Area/Main/Corpus">008891</idno><idno type="wicri:Area/Main/Repository">008C57</idno></publicationStmt><seriesStmt><idno type="ISSN">1464-4096</idno><title level="j" type="abbreviated">BJU int. : (Print)</title><title level="j" type="main">BJU international : (Papier)</title></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Diagnosis</term><term>Evaluation</term><term>Human</term><term>Latency</term><term>Medical device</term><term>Medical electronics</term><term>Nephrology</term><term>Premature ejaculation</term><term>Time</term><term>Urology</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Evaluation</term><term>Diagnostic</term><term>Dispositif médical</term><term>Latence</term><term>Temps</term><term>Ejaculation précoce</term><term>Urologie</term><term>Homme</term><term>Electronique médicale</term><term>Néphrologie</term></keywords><keywords scheme="Wicri" type="concept" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">OBJECTIVE To validate the Sexual Assessment Monitor (SAM), a novel apparatus designed to collect electronic data on ejaculatory latency time (ELT) for diagnosing premature ejaculation (PE), and for accurately measuring treatment outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS Men with PE, and healthy volunteers aged 18-75 years, were enrolled in three open-label studies, conducted in the UK. The SAM, which consists of a control box with two front attachments, a vibrator and sensor, was attached to the penis. The vibrator, which provides stimulation, was positioned at the frenulum using a soft cuff; the vibrator intensity was set at 80 units for most subjects. The sensor is an indium-gallium elasticated loop, which was positioned around the base of the penis to detect ejaculatory pulses. These pulses were transmitted to a data recorder in the control box. The data, which are displayed graphically as traces, were automatically classified by a computer-generated algorithm to quantify ELT. RESULTS In all, 53 healthy volunteers and 58 men with PE provided 213 and 195 evaluable records, respectively. Most were complete records (99% and 96%). The pooled data showed that the ELT was much higher for healthy volunteers than for men with PE (geometric means: 687 vs 169 s, respectively), with a healthy volunteer to PE patient ratio of 2.87 (P< 0.001). Only 6.3% of subjects reported mild adverse events, which were unrelated to the SAM. CONCLUSIONS These open-label studies show that the SAM can consistently and safely measure times to erection (from the start of vibration) and ejaculation, and ELT in healthy volunteers and men with PE. These findings show that the SAM has the potential to become the 'gold standard' in the diagnosis of PE and in clinical trials design.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>1464-4096</s0></fA01><fA03 i2="1"><s0>BJU int. : (Print)</s0></fA03><fA05><s2>98</s2></fA05><fA06><s2>3</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time : findings from three studies</s1></fA08><fA11 i1="01" i2="1"><s1>DINSMORE (Wallace W.)</s1></fA11><fA11 i1="02" i2="1"><s1>RALPH (David J.)</s1></fA11><fA11 i1="03" i2="1"><s1>KELL (Phillip)</s1></fA11><fA11 i1="04" i2="1"><s1>WYLIE (Kevan R.)</s1></fA11><fA11 i1="05" i2="1"><s1>DEAN (John P.)</s1></fA11><fA11 i1="06" i2="1"><s1>NOVAK (Claire)</s1></fA11><fA11 i1="07" i2="1"><s1>WYLLIE (Jennifer S.)</s1></fA11><fA11 i1="08" i2="1"><s1>WYLLIE (Michael G.)</s1></fA11><fA14 i1="01"><s1>Royal Victoria Hospital</s1><s2>Belfast</s2><s3>GBR</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Hospital of St Johns and St Elizabeth's</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Porterbrook Clinic</s1><s2>Sheffield</s2><s3>GBR</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></fA14><fA14 i1="04"><s1>The Salisbury Clinic</s1><s2>Plymouth</s2><s3>GBR</s3><sZ>5 aut.</sZ></fA14><fA14 i1="05"><s1>Plethora Solutions Ltd</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ><sZ>8 aut.</sZ></fA14><fA20><s1>613-618</s1></fA20><fA21><s1>2006</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>1050</s2><s5>354000133468390280</s5></fA43><fA44><s0>0000</s0><s1>© 2006 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>15 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>06-0445352</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>BJU international : (Papier)</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>OBJECTIVE To validate the Sexual Assessment Monitor (SAM), a novel apparatus designed to collect electronic data on ejaculatory latency time (ELT) for diagnosing premature ejaculation (PE), and for accurately measuring treatment outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS Men with PE, and healthy volunteers aged 18-75 years, were enrolled in three open-label studies, conducted in the UK. The SAM, which consists of a control box with two front attachments, a vibrator and sensor, was attached to the penis. The vibrator, which provides stimulation, was positioned at the frenulum using a soft cuff; the vibrator intensity was set at 80 units for most subjects. The sensor is an indium-gallium elasticated loop, which was positioned around the base of the penis to detect ejaculatory pulses. These pulses were transmitted to a data recorder in the control box. The data, which are displayed graphically as traces, were automatically classified by a computer-generated algorithm to quantify ELT. RESULTS In all, 53 healthy volunteers and 58 men with PE provided 213 and 195 evaluable records, respectively. Most were complete records (99% and 96%). The pooled data showed that the ELT was much higher for healthy volunteers than for men with PE (geometric means: 687 vs 169 s, respectively), with a healthy volunteer to PE patient ratio of 2.87 (P< 0.001). Only 6.3% of subjects reported mild adverse events, which were unrelated to the SAM. CONCLUSIONS These open-label studies show that the SAM can consistently and safely measure times to erection (from the start of vibration) and ejaculation, and ELT in healthy volunteers and men with PE. 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