Abstract | INTRODUCTION AND HYPOTHESIS: METHODS: Prospective open-label cohort study of women presenting primarily with UUI, diagnosed with double incontinence and electing antimuscarinic therapy for UUI. Women ≥ 18 years with moderate or greater bothersome UUI and fecal incontinence of liquid/solid stool with St. Marks (Vaizey) score ≥ 12 were included. Subjects were treated with darifenacin 15 mg daily for 8 weeks. The primary outcome was change in fecal incontinence symptom severity using the St. Marks (Vaizey) score after 8 weeks. Sample size was based on the minimally important difference of the St. Marks, -5, and standard deviation, ± 8.5; 30 subjects provided 80% power and type I error of 0.05, including a 15% attrition rate. RESULTS: Thirty-two women were consented with mean baseline St. Marks (Vaizey) score of 18.0 ± 3.0. Mean age was 66.5 ± 10.3 years. Twenty-eight subjects (29/32, 87.5%) completed assessments. St. Marks (Vaizey) score significantly improved from 18.0 to 11.0 [mean difference - 7.0, 95% confidence interval (CI): -8.7, -5.3], and 19 subjects (19/32,67.9%) met the minimally important difference. Statistically significant improvements were also noted in fecal incontinence frequency, quality of life, and overactive bladder symptom bother and quality of life (all p < 0.01). CONCLUSIONS:
Darifenacin can be considered a highly effective early intervention in women suffering from double incontinence. CLINICAL TRIAL REGISTRATION: Bladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.
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Authors | Lindsay M Kissane, Kimberly D Martin, Isuzu Meyer, Holly E Richter |
Journal | International urogynecology journal
(Int Urogynecol J)
Vol. 32
Issue 9
Pg. 2357-2363
(09 2021)
ISSN: 1433-3023 [Electronic] England |
PMID | 32542466
(Publication Type: Journal Article, Observational Study)
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Copyright | © 2020. The International Urogynecological Association. |
Chemical References |
- Benzofurans
- Pyrrolidines
- darifenacin
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Topics |
- Aged
- Benzofurans
- Cohort Studies
- Fecal Incontinence
(drug therapy)
- Female
- Humans
- Middle Aged
- Prospective Studies
- Pyrrolidines
- Quality of Life
- Treatment Outcome
- Urinary Bladder, Overactive
(complications, drug therapy)
- Urinary Incontinence
- Urinary Incontinence, Urge
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