Evidence map›Paper›PMID 32728649›Full record

ArticleContemporary clinical trials communications2020

Protocol for a multicenter randomized, double blind, controlled pilot trial of higher neural function in overactive bladder patients after anticholinergic, beta-3 adrenergic agonist, or placebo.

Rachel A High, Jill M Danford, Zhaoyue Shi, Christof Karmonik, Thomas J Kuehl, Erin T Bird, Rose Khavari

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.

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

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Rachel A HighDepartment of Obstetrics and Gynecology, Baylor Scott and White Health, 2401 South 31st Street, Temple, TX, 76508, USA.
Jill M DanfordDepartment of Urology, Baylor Scott and White Health, 2401 South 31st Street, Temple, TX, 76508, USA.
Zhaoyue ShiDepartment of MRI Core, Methodist Research Institute, 6670 Bertner Ave, Houston, TX, 77030, USA.
Christof KarmonikDepartment of MRI Core, Methodist Research Institute, 6670 Bertner Ave, Houston, TX, 77030, USA.
Thomas J KuehlDepartment of Obstetrics and Gynecology, Baylor Scott and White Health, 2401 South 31st Street, Temple, TX, 76508, USA.
Erin T BirdDepartment of Urology, Baylor Scott and White Health, 2401 South 31st Street, Temple, TX, 76508, USA.
Rose KhavariDepartment of Urology, Methodist Hospital, 6560 Fannin St. Ste 2100, Houston, TX, 77030, USA.
Baylor Scott & White Health · USIST Research · USMethodist Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOveractive bladder (OAB) syndrome has a negative impact on quality of life and prevalence increases with advanced age. Anticholinergics (AC) and beta-3 adrenergic agonists (β3a) are commonly prescribed medications for treatment of OAB. AC medication has been associated with dementia in population studies and with cortical atrophy in imaging studies. Higher neural effects of both classes of OAB medications have not been evaluated with functional neuroimaging. Longitudinal clinical assessments of cognition after OAB therapy with AC has produced conflicting results. β3a medication is has not been associated with dementia in clinical studies; however, higher neural effects are unknown.Our multicenter, double blind, randomized, placebo-controlled trial uses functional magnetic resonance imaging (fMRI) and cognitive testing to evaluate the effects of AC and β3a on brain functional connectivity in females with non-neurogenic OAB. METHODS AND ANALYSIS: and analysis: Female patients with OAB symptoms ages 50-90 years old without baseline cognitive impairment, moderate to severe depression or anxiety, neurologic disorders, or significant incomplete bladder emptying are invited to participate. Subjects are randomized to one of three interventions for 29 ± 1 day: AC (Solifenacin succinate, Teva), β3a (Mirabegron, Myrbetriq, Astellas), or placebo. Functional neuroimaging data at baseline and post-intervention will be analyzed accordingly. Clinical cognitive assessments will be compared from baseline to post-intervention. ETHICS: All qualifying patients are properly consented before enrolling in this study that has been approved by the Institutional Review Board of participating institutions.

Indexed as

Cognitive dysfunctionMirabegronOveractive bladder syndromeSolifenacinUrinary incontinence

Identifiers

PMID32728649
PMCPMC7381509
OpenAlexW3043633568

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.