MARC details
| 000 -LEADER |
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| fixed length control field |
03718nam a22005417a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
190314s20192019 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
2151-8378 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
01436319-201903000-00007 [pii] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1097/SPV.0000000000000681 [doi] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
30807411 |
| 245 ## - TITLE STATEMENT |
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| Title |
A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence. |
| 251 ## - Source |
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| Source |
Female Pelvic Medicine & Reconstructive Surgery. 25(2):113-119, 2019 Mar/Apr. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Female pelvic med. reconstr. surg.. 25(2):113-119, 2019 Mar/Apr. |
| 253 ## - Journal Name |
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| Journal name |
Female pelvic medicine & reconstructive surgery |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2019 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2019 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2019-03-14 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: In women with successful fitting and initial treatment response, durable efficacy was seen at 3, 6, and 12 months by objective and subjective measures, with favorable safety. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50% or greater reduction in baseline FI episodes, also assessed at 6 and 12 months. Secondary outcomes included symptom impact measured with Fecal Incontinence Quality of Life scale, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events were collected. Primary analysis was intention to treat (ITT). |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
OBJECTIVE: The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: Seventy-three subjects with baseline mean of 14.1 +/- 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6% (53/73, P < 0.0001); per-protocol, 84.1% (53/63, P < 0.0001). Significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark's questionnaire meeting minimally important differences was noted. Satisfaction was 91.7%, 89.7%, and 94.4% at 3, 6, and 12 months, respectively; 77.4%, 77.6%, and 79.6% were very much/much better on the Patient Global Impression of Improvement at 3, 6, and 12 months, respectively. Most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during fitting period. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Equipment and Supplies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Fecal Incontinence/th [Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Adult |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged, 80 and over |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Equipment and Supplies/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Middle Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Patient Satisfaction |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prospective Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Quality of Life |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Severity of Illness Index |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Vagina/in [Injuries] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Young Adult |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Washington Hospital Center |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive Surgery |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Gutman, Robert E |
| 790 ## - Authors |
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| All authors |
Andy U, Brown HW, Dunivan G, Dyer KY, Gutman RE, McNevin S, Muir T, Paquette I, Quiroz L, Rardin C, Richter HE, Wu J |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1097/SPV.0000000000000681">https://dx.doi.org/10.1097/SPV.0000000000000681</a> |
| Public note |
https://dx.doi.org/10.1097/SPV.0000000000000681 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
