Botulinum A Toxin/Dimethyl Sulfoxide Bladder Instillations for Women With Refractory Idiopathic Detrusor Overactivity: A Phase 1/2 Study
We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirme...
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| creator | Petrou, Steven P., MD Parker, Alexander S., PhD Crook, Julia E., PhD Rogers, Alexandra, MD Metz-Kudashick, Dorothea, LPN Thiel, David D., MD |
| description | We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month ( P =.004) and increased to 4 at 3 months ( P =.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P =.007) and Urogenital Distress Inventory (from 10 to 5; P =.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P |
| doi_str_mv | 10.4065/84.8.702 |
| format | Article |
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Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month ( P =.004) and increased to 4 at 3 months ( P =.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P =.007) and Urogenital Distress Inventory (from 10 to 5; P =.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P <.001) and 3 (14%; P =.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.</description><identifier>ISSN: 0025-6196</identifier><identifier>EISSN: 1942-5546</identifier><identifier>DOI: 10.4065/84.8.702</identifier><identifier>PMID: 19648387</identifier><identifier>CODEN: MACPAJ</identifier><language>eng</language><publisher>Rochester, MN: Elsevier Inc</publisher><subject>Administration, Intravesical ; Adult ; Aged ; Aged, 80 and over ; Analysis of Variance ; Biological and medical sciences ; Botulinum Toxins, Type A - administration & dosage ; Botulinum Toxins, Type A - adverse effects ; Brief Report ; Dimethyl sulfoxide ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Follow-Up Studies ; General aspects ; Humans ; Internal Medicine ; Medical research ; Medical sciences ; Medicine, Experimental ; Nephrology. Urinary tract diseases ; Pilot Projects ; Probability ; Prospective Studies ; Risk Assessment ; Severity of Illness Index ; Treatment Outcome ; Urinary Bladder, Overactive - diagnosis ; Urinary Bladder, Overactive - drug therapy ; Urinary incontinence ; Urinary system involvement in other diseases. Miscellaneous ; Urinary tract. Prostate gland ; Urodynamics ; Women</subject><ispartof>Mayo Clinic proceedings, 2009-08, Vol.84 (8), p.702-706</ispartof><rights>Mayo Foundation for Medical Education and Research</rights><rights>2009 Mayo Foundation for Medical Education and Research</rights><rights>2009 INIST-CNRS</rights><rights>COPYRIGHT 2009 Elsevier, Inc.</rights><rights>Copyright Mayo Foundation for Medical Education and Research Aug 2009</rights><rights>2009 Mayo Foundation for Medical Education and Research 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c561t-df3ca2011da86f3e3bd14558f1063658064c65342d4bd4534b0159baec25fc6b3</citedby><cites>FETCH-LOGICAL-c561t-df3ca2011da86f3e3bd14558f1063658064c65342d4bd4534b0159baec25fc6b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2719523/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2719523/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21820538$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19648387$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Petrou, Steven P., MD</creatorcontrib><creatorcontrib>Parker, Alexander S., PhD</creatorcontrib><creatorcontrib>Crook, Julia E., PhD</creatorcontrib><creatorcontrib>Rogers, Alexandra, MD</creatorcontrib><creatorcontrib>Metz-Kudashick, Dorothea, LPN</creatorcontrib><creatorcontrib>Thiel, David D., MD</creatorcontrib><title>Botulinum A Toxin/Dimethyl Sulfoxide Bladder Instillations for Women With Refractory Idiopathic Detrusor Overactivity: A Phase 1/2 Study</title><title>Mayo Clinic proceedings</title><addtitle>Mayo Clin Proc</addtitle><description>We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month ( P =.004) and increased to 4 at 3 months ( P =.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P =.007) and Urogenital Distress Inventory (from 10 to 5; P =.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P <.001) and 3 (14%; P =.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.</description><subject>Administration, Intravesical</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analysis of Variance</subject><subject>Biological and medical sciences</subject><subject>Botulinum Toxins, Type A - administration & dosage</subject><subject>Botulinum Toxins, Type A - adverse effects</subject><subject>Brief Report</subject><subject>Dimethyl sulfoxide</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>General aspects</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Medicine, Experimental</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Pilot Projects</subject><subject>Probability</subject><subject>Prospective Studies</subject><subject>Risk Assessment</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><subject>Urinary Bladder, Overactive - diagnosis</subject><subject>Urinary Bladder, Overactive - drug therapy</subject><subject>Urinary incontinence</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Urinary tract. Prostate gland</subject><subject>Urodynamics</subject><subject>Women</subject><issn>0025-6196</issn><issn>1942-5546</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><recordid>eNptkt9u0zAUxiMEYmUg8QTIQgJx09Z2bDfZxaRu40-lSUN0aNxZrn2yeCRxsZ2KvAGPjUursiHkC1vHv_Md-5wvy14SPGFY8GnBJsVkhumjbERKRsecM_E4G2FM-ViQUhxlz0K4wxjPypI9zY5SiBV5MRtlv85c7Bvb9S2ao2v303bTC9tCrIcGLfumShED6KxRxoBHiy5E2zQqWtcFVDmPblwLHbqxsUZfoPJKR-cHtDDWrVWsrUYXEH0fEnm1ge213dg4nKRin2sVAJEpRcvYm-F59qRSTYAX-_04-_rh_fX5p_Hl1cfF-fxyrLkgcWyqXCuKCTGqEFUO-coQxnlRESxywQssmBY8Z9SwlWHpsMKElysFmvJKi1V-nJ3udNf9qgWjoYteNXLtbav8IJ2y8uFNZ2t56zaSzkjJaZ4EXu8FvPvRQ4jyzvW-S2-WlIhixsucJmiyg25VA9J2lUtaOi0DrdWug8qm-JxiQTll5Vb17b2EGlQT6-Ca_k-nH4LvdqD2LgQP1eHpBMutGWTBZCGTGRL66v5X_4L76SfgzR5QQasmja_TNhw4SgqKeV4kju44SIPZWPAyaAudBmM96CiNs_-rfvpPkk4-s6nOdxggHJpGZKASy-XWrFuvEiIwp_hb_hu0z-II</recordid><startdate>20090801</startdate><enddate>20090801</enddate><creator>Petrou, Steven P., MD</creator><creator>Parker, Alexander S., PhD</creator><creator>Crook, Julia E., PhD</creator><creator>Rogers, Alexandra, MD</creator><creator>Metz-Kudashick, Dorothea, LPN</creator><creator>Thiel, David D., MD</creator><general>Elsevier Inc</general><general>Mayo Foundation</general><general>Elsevier, Inc</general><general>Elsevier Limited</general><general>Mayo Foundation for Medical Education and Research</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>3V.</scope><scope>4U-</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>5PM</scope></search><sort><creationdate>20090801</creationdate><title>Botulinum A Toxin/Dimethyl Sulfoxide Bladder Instillations for Women With Refractory Idiopathic Detrusor Overactivity: A Phase 1/2 Study</title><author>Petrou, Steven P., MD ; Parker, Alexander S., PhD ; Crook, Julia E., PhD ; Rogers, Alexandra, MD ; Metz-Kudashick, Dorothea, LPN ; Thiel, David D., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c561t-df3ca2011da86f3e3bd14558f1063658064c65342d4bd4534b0159baec25fc6b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Administration, Intravesical</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analysis of Variance</topic><topic>Biological and medical sciences</topic><topic>Botulinum Toxins, Type A - administration & dosage</topic><topic>Botulinum Toxins, Type A - adverse effects</topic><topic>Brief Report</topic><topic>Dimethyl sulfoxide</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>General aspects</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Medicine, Experimental</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Pilot Projects</topic><topic>Probability</topic><topic>Prospective Studies</topic><topic>Risk Assessment</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><topic>Urinary Bladder, Overactive - diagnosis</topic><topic>Urinary Bladder, Overactive - drug therapy</topic><topic>Urinary incontinence</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Urinary tract. Prostate gland</topic><topic>Urodynamics</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Petrou, Steven P., MD</creatorcontrib><creatorcontrib>Parker, Alexander S., PhD</creatorcontrib><creatorcontrib>Crook, Julia E., PhD</creatorcontrib><creatorcontrib>Rogers, Alexandra, MD</creatorcontrib><creatorcontrib>Metz-Kudashick, Dorothea, LPN</creatorcontrib><creatorcontrib>Thiel, David D., MD</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>ProQuest Central (Corporate)</collection><collection>University Readers</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Mayo Clinic proceedings</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Petrou, Steven P., MD</au><au>Parker, Alexander S., PhD</au><au>Crook, Julia E., PhD</au><au>Rogers, Alexandra, MD</au><au>Metz-Kudashick, Dorothea, LPN</au><au>Thiel, David D., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Botulinum A Toxin/Dimethyl Sulfoxide Bladder Instillations for Women With Refractory Idiopathic Detrusor Overactivity: A Phase 1/2 Study</atitle><jtitle>Mayo Clinic proceedings</jtitle><addtitle>Mayo Clin Proc</addtitle><date>2009-08-01</date><risdate>2009</risdate><volume>84</volume><issue>8</issue><spage>702</spage><epage>706</epage><pages>702-706</pages><issn>0025-6196</issn><eissn>1942-5546</eissn><coden>MACPAJ</coden><abstract>We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month ( P =.004) and increased to 4 at 3 months ( P =.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P =.007) and Urogenital Distress Inventory (from 10 to 5; P =.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P <.001) and 3 (14%; P =.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.</abstract><cop>Rochester, MN</cop><pub>Elsevier Inc</pub><pmid>19648387</pmid><doi>10.4065/84.8.702</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Administration, Intravesical Adult Aged Aged, 80 and over Analysis of Variance Biological and medical sciences Botulinum Toxins, Type A - administration & dosage Botulinum Toxins, Type A - adverse effects Brief Report Dimethyl sulfoxide Dose-Response Relationship, Drug Drug Administration Schedule Female Follow-Up Studies General aspects Humans Internal Medicine Medical research Medical sciences Medicine, Experimental Nephrology. Urinary tract diseases Pilot Projects Probability Prospective Studies Risk Assessment Severity of Illness Index Treatment Outcome Urinary Bladder, Overactive - diagnosis Urinary Bladder, Overactive - drug therapy Urinary incontinence Urinary system involvement in other diseases. Miscellaneous Urinary tract. Prostate gland Urodynamics Women |
| title | Botulinum A Toxin/Dimethyl Sulfoxide Bladder Instillations for Women With Refractory Idiopathic Detrusor Overactivity: A Phase 1/2 Study |
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