A digital health program for treatment of urinary incontinence: retrospective review of real-world user data
Introduction and hypothesis To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. Methods This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle train...
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| Veröffentlicht in: | International Urogynecology Journal 2023-05, Vol.34 (5), p.1083-1089 |
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| creator | Keyser, Laura E. McKinney, Jessica L. Pulliam, Samantha J. Weinstein, Milena M. |
| description | Introduction and hypothesis
To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users.
Methods
This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020–December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired
t
-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups.
Results
Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22–84,
N
= 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m
2
(range 15.2–46.9,
N
= 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (
p
≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified.
Conclusions
This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period. |
| doi_str_mv | 10.1007/s00192-022-05321-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10284973</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2702484773</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-e435c0097afafe114d3d77165935c6fbe5ba3ee85fdbe25923847b954910c5cd3</originalsourceid><addsrcrecordid>eNp9kUtv1DAUhS0EokPhD7BAltiwCVy_kpgNqipeUiU2sLYc52bGVWIPtjMV_x5Pp5THgoVl2fe75_r4EPKcwWsG0L3JAEzzBnhdSnDWiAdkw6QQjQAuHpINaNE1Qrb8jDzJ-RoAJCh4TM6E0q3mUm_IfEFHv_XFznSHdi47uk9xm-xCp5hoSWjLgqHQONE1-WDTD-qDi6H4gMHhW5qwpJj36Io_YD0dPN4c6do5NzcxzSNdMyY62mKfkkeTnTM-u9vPybcP779efmquvnz8fHlx1TjZqdKgFMoB6M5OdkLG5CjGrmOt0vW-nQZUgxWIvZrGAbnSXPSyG7SSmoFTbhTn5N1Jd78OC46uGkh2Nvvkl2rAROvN35Xgd2YbD4YB76XuRFV4daeQ4vcVczGLzw7n2QaMaza8Ay7r1Fv05T_odVxTqP4M7xmDvhetrBQ_Ua7-Vk443b-GgTmmaU5pmpqmuU3THKVf_OnjvuVXfBUQJyDXUthi-j37P7I_ARlarK8</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2811088364</pqid></control><display><type>article</type><title>A digital health program for treatment of urinary incontinence: retrospective review of real-world user data</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Keyser, Laura E. ; McKinney, Jessica L. ; Pulliam, Samantha J. ; Weinstein, Milena M.</creator><creatorcontrib>Keyser, Laura E. ; McKinney, Jessica L. ; Pulliam, Samantha J. ; Weinstein, Milena M.</creatorcontrib><description>Introduction and hypothesis
To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users.
Methods
This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020–December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired
t
-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups.
Results
Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22–84,
N
= 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m
2
(range 15.2–46.9,
N
= 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (
p
≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified.
Conclusions
This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.</description><identifier>ISSN: 0937-3462</identifier><identifier>EISSN: 1433-3023</identifier><identifier>DOI: 10.1007/s00192-022-05321-3</identifier><identifier>PMID: 35969249</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Body mass index ; Exercise Therapy ; Female ; Gynecology ; Humans ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original ; Original Article ; Pelvic Floor ; Quality of Life ; Retrospective Studies ; Telemedicine ; Treatment Outcome ; Urinary incontinence ; Urinary Incontinence - therapy ; Urinary Incontinence, Stress - diagnosis ; Urinary Incontinence, Stress - therapy ; Urinary Incontinence, Urge ; Urology ; Young Adult</subject><ispartof>International Urogynecology Journal, 2023-05, Vol.34 (5), p.1083-1089</ispartof><rights>The Author(s) 2022. corrected publication 2023</rights><rights>2022. The International Urogynecological Association.</rights><rights>The Author(s) 2022. corrected publication 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2022, corrected publication 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-e435c0097afafe114d3d77165935c6fbe5ba3ee85fdbe25923847b954910c5cd3</citedby><cites>FETCH-LOGICAL-c475t-e435c0097afafe114d3d77165935c6fbe5ba3ee85fdbe25923847b954910c5cd3</cites><orcidid>0000-0002-4168-9575</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00192-022-05321-3$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00192-022-05321-3$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35969249$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Keyser, Laura E.</creatorcontrib><creatorcontrib>McKinney, Jessica L.</creatorcontrib><creatorcontrib>Pulliam, Samantha J.</creatorcontrib><creatorcontrib>Weinstein, Milena M.</creatorcontrib><title>A digital health program for treatment of urinary incontinence: retrospective review of real-world user data</title><title>International Urogynecology Journal</title><addtitle>Int Urogynecol J</addtitle><addtitle>Int Urogynecol J</addtitle><description>Introduction and hypothesis
To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users.
Methods
This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020–December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired
t
-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups.
Results
Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22–84,
N
= 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m
2
(range 15.2–46.9,
N
= 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (
p
≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified.
Conclusions
This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Body mass index</subject><subject>Exercise Therapy</subject><subject>Female</subject><subject>Gynecology</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Original Article</subject><subject>Pelvic Floor</subject><subject>Quality of Life</subject><subject>Retrospective Studies</subject><subject>Telemedicine</subject><subject>Treatment Outcome</subject><subject>Urinary incontinence</subject><subject>Urinary Incontinence - therapy</subject><subject>Urinary Incontinence, Stress - diagnosis</subject><subject>Urinary Incontinence, Stress - therapy</subject><subject>Urinary Incontinence, Urge</subject><subject>Urology</subject><subject>Young Adult</subject><issn>0937-3462</issn><issn>1433-3023</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kUtv1DAUhS0EokPhD7BAltiwCVy_kpgNqipeUiU2sLYc52bGVWIPtjMV_x5Pp5THgoVl2fe75_r4EPKcwWsG0L3JAEzzBnhdSnDWiAdkw6QQjQAuHpINaNE1Qrb8jDzJ-RoAJCh4TM6E0q3mUm_IfEFHv_XFznSHdi47uk9xm-xCp5hoSWjLgqHQONE1-WDTD-qDi6H4gMHhW5qwpJj36Io_YD0dPN4c6do5NzcxzSNdMyY62mKfkkeTnTM-u9vPybcP779efmquvnz8fHlx1TjZqdKgFMoB6M5OdkLG5CjGrmOt0vW-nQZUgxWIvZrGAbnSXPSyG7SSmoFTbhTn5N1Jd78OC46uGkh2Nvvkl2rAROvN35Xgd2YbD4YB76XuRFV4daeQ4vcVczGLzw7n2QaMaza8Ay7r1Fv05T_odVxTqP4M7xmDvhetrBQ_Ua7-Vk443b-GgTmmaU5pmpqmuU3THKVf_OnjvuVXfBUQJyDXUthi-j37P7I_ARlarK8</recordid><startdate>20230501</startdate><enddate>20230501</enddate><creator>Keyser, Laura E.</creator><creator>McKinney, Jessica L.</creator><creator>Pulliam, Samantha J.</creator><creator>Weinstein, Milena M.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-4168-9575</orcidid></search><sort><creationdate>20230501</creationdate><title>A digital health program for treatment of urinary incontinence: retrospective review of real-world user data</title><author>Keyser, Laura E. ; McKinney, Jessica L. ; Pulliam, Samantha J. ; Weinstein, Milena M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-e435c0097afafe114d3d77165935c6fbe5ba3ee85fdbe25923847b954910c5cd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Body mass index</topic><topic>Exercise Therapy</topic><topic>Female</topic><topic>Gynecology</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Original Article</topic><topic>Pelvic Floor</topic><topic>Quality of Life</topic><topic>Retrospective Studies</topic><topic>Telemedicine</topic><topic>Treatment Outcome</topic><topic>Urinary incontinence</topic><topic>Urinary Incontinence - therapy</topic><topic>Urinary Incontinence, Stress - diagnosis</topic><topic>Urinary Incontinence, Stress - therapy</topic><topic>Urinary Incontinence, Urge</topic><topic>Urology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Keyser, Laura E.</creatorcontrib><creatorcontrib>McKinney, Jessica L.</creatorcontrib><creatorcontrib>Pulliam, Samantha J.</creatorcontrib><creatorcontrib>Weinstein, Milena M.</creatorcontrib><collection>Springer Nature OA Free Journals</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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</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)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</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>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International Urogynecology Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Keyser, Laura E.</au><au>McKinney, Jessica L.</au><au>Pulliam, Samantha J.</au><au>Weinstein, Milena M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A digital health program for treatment of urinary incontinence: retrospective review of real-world user data</atitle><jtitle>International Urogynecology Journal</jtitle><stitle>Int Urogynecol J</stitle><addtitle>Int Urogynecol J</addtitle><date>2023-05-01</date><risdate>2023</risdate><volume>34</volume><issue>5</issue><spage>1083</spage><epage>1089</epage><pages>1083-1089</pages><issn>0937-3462</issn><eissn>1433-3023</eissn><abstract>Introduction and hypothesis
To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users.
Methods
This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020–December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired
t
-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups.
Results
Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22–84,
N
= 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m
2
(range 15.2–46.9,
N
= 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (
p
≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified.
Conclusions
This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>35969249</pmid><doi>10.1007/s00192-022-05321-3</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-4168-9575</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0937-3462 |
| ispartof | International Urogynecology Journal, 2023-05, Vol.34 (5), p.1083-1089 |
| issn | 0937-3462 1433-3023 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Aged Aged, 80 and over Body mass index Exercise Therapy Female Gynecology Humans Male Medicine Medicine & Public Health Middle Aged Original Original Article Pelvic Floor Quality of Life Retrospective Studies Telemedicine Treatment Outcome Urinary incontinence Urinary Incontinence - therapy Urinary Incontinence, Stress - diagnosis Urinary Incontinence, Stress - therapy Urinary Incontinence, Urge Urology Young Adult |
| title | A digital health program for treatment of urinary incontinence: retrospective review of real-world user data |
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