Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies
Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands OBJECTIVE To validate the Sexual Assessment Monitor (SAM), a...
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| Veröffentlicht in: | BJU international 2006-09, Vol.98 (3), p.613-618 |
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| creator | DINSMORE, WALLACE W. RALPH, DAVID J. KELL, PHILLIP WYLIE, KEVAN R. DEAN, JOHN P. NOVAK, CLAIRE WYLLIE, JENNIFER S. WYLLIE, MICHAEL G. |
| description | Associate Editor
Michael G. Wyllie
Editorial Board
Ian Eardley, UK
Jean Fourcroy, USA
Sidney Glina, Brazil
Julia Heiman, USA
Chris McMahon, Australia
Bob Millar, UK
Alvaro Morales, Canada
Michael Perelman, USA
Marcel Waldinger, Netherlands
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 |
| doi_str_mv | 10.1111/j.1464-410X.2006.06286.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_68781400</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>68781400</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3976-1b4f67dee513f3cf7d8b7b23ac9992c9392b8ba472e054cf5a7a0029b76bc3ff3</originalsourceid><addsrcrecordid>eNqNkc1u1TAQhSMEoqXwCsgbWHGD7SROjMSircqfilhAJXaW44yLrxy79U-5eRGeF4d7oVu8mZH9nRnrnKpCBNeknNfbmrSs3bQEf68pxqzGjA6s3j2ojv89PPzbY86OqicxbjEuF6x7XB0RxmnXM3pc_bq4kzbLZLxDXqP0A9BX2GVp0WmMEOMMLqHP3pnkwysk0WTktfMxGYUmuDMKUI4woeQRWFApFFJJaxd0m6VLRi8ItlJlK4t-QaWAUwtKZoY3SBs3GXcdkQ5-LqsDAIopTwbi0-qRljbCs0M9qa7eXXw7_7C5_PL-4_np5UY1vGcbMraa9RNARxrdKN1Pw9iPtJGKc04Vbzgdh1G2PQXctUp3spcYUz72bFSN1s1J9XI_9yb42wwxidlEBdZKBz5HwYZ-IC3GBRz2oAo-xgBa3AQzy7AIgsWaidiK1W6xWi_WTMSfTMSuSJ8fduRxhuleeAihAC8OgIzFPB2kUybecwOmhJOhcG_33E9jYfnvD4izT1dr1_wGvHusGA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>68781400</pqid></control><display><type>article</type><title>Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies</title><source>MEDLINE</source><source>Wiley Online Library All Journals</source><creator>DINSMORE, WALLACE W. ; RALPH, DAVID J. ; KELL, PHILLIP ; WYLIE, KEVAN R. ; DEAN, JOHN P. ; NOVAK, CLAIRE ; WYLLIE, JENNIFER S. ; WYLLIE, MICHAEL G.</creator><creatorcontrib>DINSMORE, WALLACE W. ; RALPH, DAVID J. ; KELL, PHILLIP ; WYLIE, KEVAN R. ; DEAN, JOHN P. ; NOVAK, CLAIRE ; WYLLIE, JENNIFER S. ; WYLLIE, MICHAEL G.</creatorcontrib><description>Associate Editor
Michael G. Wyllie
Editorial Board
Ian Eardley, UK
Jean Fourcroy, USA
Sidney Glina, Brazil
Julia Heiman, USA
Chris McMahon, Australia
Bob Millar, UK
Alvaro Morales, Canada
Michael Perelman, USA
Marcel Waldinger, Netherlands
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.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/j.1464-410X.2006.06286.x</identifier><identifier>PMID: 16925762</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Andrology - instrumentation ; Biological and medical sciences ; Ejaculation - physiology ; Electronics ; Equipment Design ; Genital system. Mammary gland ; Humans ; Investigative techniques, diagnostic techniques (general aspects) ; Male ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques ; PE diagnosis ; PE diagnostic device ; Penile Erection - physiology ; Pilot Projects ; premature ejaculation ; Reaction Time ; sexual assessment monitor ; Sexual Dysfunction, Physiological - diagnosis ; Sexual Dysfunction, Physiological - physiopathology ; Vibration</subject><ispartof>BJU international, 2006-09, Vol.98 (3), p.613-618</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3976-1b4f67dee513f3cf7d8b7b23ac9992c9392b8ba472e054cf5a7a0029b76bc3ff3</citedby><cites>FETCH-LOGICAL-c3976-1b4f67dee513f3cf7d8b7b23ac9992c9392b8ba472e054cf5a7a0029b76bc3ff3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1464-410X.2006.06286.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1464-410X.2006.06286.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18021918$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16925762$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>DINSMORE, WALLACE W.</creatorcontrib><creatorcontrib>RALPH, DAVID J.</creatorcontrib><creatorcontrib>KELL, PHILLIP</creatorcontrib><creatorcontrib>WYLIE, KEVAN R.</creatorcontrib><creatorcontrib>DEAN, JOHN P.</creatorcontrib><creatorcontrib>NOVAK, CLAIRE</creatorcontrib><creatorcontrib>WYLLIE, JENNIFER S.</creatorcontrib><creatorcontrib>WYLLIE, MICHAEL G.</creatorcontrib><title>Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>Associate Editor
Michael G. Wyllie
Editorial Board
Ian Eardley, UK
Jean Fourcroy, USA
Sidney Glina, Brazil
Julia Heiman, USA
Chris McMahon, Australia
Bob Millar, UK
Alvaro Morales, Canada
Michael Perelman, USA
Marcel Waldinger, Netherlands
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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Andrology - instrumentation</subject><subject>Biological and medical sciences</subject><subject>Ejaculation - physiology</subject><subject>Electronics</subject><subject>Equipment Design</subject><subject>Genital system. Mammary gland</subject><subject>Humans</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques</subject><subject>PE diagnosis</subject><subject>PE diagnostic device</subject><subject>Penile Erection - physiology</subject><subject>Pilot Projects</subject><subject>premature ejaculation</subject><subject>Reaction Time</subject><subject>sexual assessment monitor</subject><subject>Sexual Dysfunction, Physiological - diagnosis</subject><subject>Sexual Dysfunction, Physiological - physiopathology</subject><subject>Vibration</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc1u1TAQhSMEoqXwCsgbWHGD7SROjMSircqfilhAJXaW44yLrxy79U-5eRGeF4d7oVu8mZH9nRnrnKpCBNeknNfbmrSs3bQEf68pxqzGjA6s3j2ojv89PPzbY86OqicxbjEuF6x7XB0RxmnXM3pc_bq4kzbLZLxDXqP0A9BX2GVp0WmMEOMMLqHP3pnkwysk0WTktfMxGYUmuDMKUI4woeQRWFApFFJJaxd0m6VLRi8ItlJlK4t-QaWAUwtKZoY3SBs3GXcdkQ5-LqsDAIopTwbi0-qRljbCs0M9qa7eXXw7_7C5_PL-4_np5UY1vGcbMraa9RNARxrdKN1Pw9iPtJGKc04Vbzgdh1G2PQXctUp3spcYUz72bFSN1s1J9XI_9yb42wwxidlEBdZKBz5HwYZ-IC3GBRz2oAo-xgBa3AQzy7AIgsWaidiK1W6xWi_WTMSfTMSuSJ8fduRxhuleeAihAC8OgIzFPB2kUybecwOmhJOhcG_33E9jYfnvD4izT1dr1_wGvHusGA</recordid><startdate>200609</startdate><enddate>200609</enddate><creator>DINSMORE, WALLACE W.</creator><creator>RALPH, DAVID J.</creator><creator>KELL, PHILLIP</creator><creator>WYLIE, KEVAN R.</creator><creator>DEAN, JOHN P.</creator><creator>NOVAK, CLAIRE</creator><creator>WYLLIE, JENNIFER S.</creator><creator>WYLLIE, MICHAEL G.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200609</creationdate><title>Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies</title><author>DINSMORE, WALLACE W. ; RALPH, DAVID J. ; KELL, PHILLIP ; WYLIE, KEVAN R. ; DEAN, JOHN P. ; NOVAK, CLAIRE ; WYLLIE, JENNIFER S. ; WYLLIE, MICHAEL G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3976-1b4f67dee513f3cf7d8b7b23ac9992c9392b8ba472e054cf5a7a0029b76bc3ff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Andrology - instrumentation</topic><topic>Biological and medical sciences</topic><topic>Ejaculation - physiology</topic><topic>Electronics</topic><topic>Equipment Design</topic><topic>Genital system. Mammary gland</topic><topic>Humans</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques</topic><topic>PE diagnosis</topic><topic>PE diagnostic device</topic><topic>Penile Erection - physiology</topic><topic>Pilot Projects</topic><topic>premature ejaculation</topic><topic>Reaction Time</topic><topic>sexual assessment monitor</topic><topic>Sexual Dysfunction, Physiological - diagnosis</topic><topic>Sexual Dysfunction, Physiological - physiopathology</topic><topic>Vibration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>DINSMORE, WALLACE W.</creatorcontrib><creatorcontrib>RALPH, DAVID J.</creatorcontrib><creatorcontrib>KELL, PHILLIP</creatorcontrib><creatorcontrib>WYLIE, KEVAN R.</creatorcontrib><creatorcontrib>DEAN, JOHN P.</creatorcontrib><creatorcontrib>NOVAK, CLAIRE</creatorcontrib><creatorcontrib>WYLLIE, JENNIFER S.</creatorcontrib><creatorcontrib>WYLLIE, MICHAEL G.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>DINSMORE, WALLACE W.</au><au>RALPH, DAVID J.</au><au>KELL, PHILLIP</au><au>WYLIE, KEVAN R.</au><au>DEAN, JOHN P.</au><au>NOVAK, CLAIRE</au><au>WYLLIE, JENNIFER S.</au><au>WYLLIE, MICHAEL G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2006-09</date><risdate>2006</risdate><volume>98</volume><issue>3</issue><spage>613</spage><epage>618</epage><pages>613-618</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>Associate Editor
Michael G. Wyllie
Editorial Board
Ian Eardley, UK
Jean Fourcroy, USA
Sidney Glina, Brazil
Julia Heiman, USA
Chris McMahon, Australia
Bob Millar, UK
Alvaro Morales, Canada
Michael Perelman, USA
Marcel Waldinger, Netherlands
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.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>16925762</pmid><doi>10.1111/j.1464-410X.2006.06286.x</doi><tpages>6</tpages></addata></record> |
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| ispartof | BJU international, 2006-09, Vol.98 (3), p.613-618 |
| issn | 1464-4096 1464-410X |
| language | eng |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | Adolescent Adult Aged Andrology - instrumentation Biological and medical sciences Ejaculation - physiology Electronics Equipment Design Genital system. Mammary gland Humans Investigative techniques, diagnostic techniques (general aspects) Male Medical sciences Middle Aged Nephrology. Urinary tract diseases Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques PE diagnosis PE diagnostic device Penile Erection - physiology Pilot Projects premature ejaculation Reaction Time sexual assessment monitor Sexual Dysfunction, Physiological - diagnosis Sexual Dysfunction, Physiological - physiopathology Vibration |
| title | Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies |
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