TY  - BOOK
AU  - Gutman, Robert E
TI  - A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence
SN  - 2151-8378
PY  - 2019///
KW  - *Equipment and Supplies
KW  - *Fecal Incontinence/th [Therapy]
KW  - Adult
KW  - Aged
KW  - Aged, 80 and over
KW  - Equipment and Supplies/ae [Adverse Effects]
KW  - Female
KW  - Humans
KW  - Middle Aged
KW  - Patient Satisfaction
KW  - Prospective Studies
KW  - Quality of Life
KW  - Severity of Illness Index
KW  - Treatment Outcome
KW  - Vagina/in [Injuries]
KW  - Young Adult
KW  - MedStar Washington Hospital Center
KW  - Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive Surgery
KW  - Journal Article
N2  - 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; 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); 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; 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
UR  - https://dx.doi.org/10.1097/SPV.0000000000000681
ER  -