Evidence map›Paper›PMID 32542466›Full record

Observational studyInternational urogynecology journal2021

Effect of darifenacin on fecal incontinence in women with double incontinence.

Lindsay M Kissane, Kimberly D Martin, Isuzu Meyer, Holly E Richter

Registry-linked trialOpen access · greenAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in International urogynecology journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03543566 (Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03543566 completednot on this map

Antimuscarinic Medication for Urgency Urinary Incontinence in Women With Dual Incontinence (Darifenacin for Treatment of Women With Dual Incontinence)

TypeobservationalSponsorUniversity of Alabama at BirminghamRan2018 to 2019Enrolled32ConditionsUrinary Incontinence, Urge, Fecal Incontinence
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Lindsay M KissaneDivision of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, 1700 6th Ave S.WIC Rm 10382, Birmingham, AL, 35233, USA. Lindsay.kissane.md@adventhealth.com.ORCID 0000-0002-0013-3693
Kimberly D MartinDepartment of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA.
Isuzu MeyerDivision of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, 1700 6th Ave S.WIC Rm 10382, Birmingham, AL, 35233, USA.
Holly E RichterDivision of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, 1700 6th Ave S.WIC Rm 10382, Birmingham, AL, 35233, USA.
University of Alabama at Birmingham · US

Funding

OB/GYN FACULTY RESEARCH CAREER DEVELOPMENT PROGRAMK12HD001258 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI JENKINS, TODD R · 1999 to 2019
$5.6M
NICHD NIH HHS K12 HD001258
6 · The paper itself

Abstract

introduction and hypothesisTo evaluate change in fecal incontinence symptom severity after 8 weeks of darifenacin therapy in patients with double incontinence-urgency urinary incontinence (UUI) and fecal incontinence. Important secondary outcomes included fecal incontinence symptom distress and impact on quality of life, fecal incontinence episodes, global impression of improvement and overactive bladder symptom distress and impact.

methodsProspective 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.

resultsThirty-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).

conclusionsDarifenacin can be considered a highly effective early intervention in women suffering from double incontinence. CLINICAL

trial registrationBladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.

Indexed as

Fecal IncontinenceUrinary Bladder, OveractiveUrinary IncontinenceAgedBenzofuransCohort StudiesFemaleHumansMiddle AgedProspective StudiesPyrrolidinesQuality of LifeTreatment OutcomeUrinary Incontinence, UrgeBenzofuransdarifenacinPyrrolidinesAccidental bowel leakageDouble incontinenceDual incontinenceFecal incontinenceOveractive bladderUrge urinary incontinence

Identifiers

PMID32542466
PMCPMC7736065
OpenAlexW3035414831

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.