Evidence map›Paper›PMID 22909146›Full record

Trial reportClinical drug investigation2012

Cognitive effects of oxybutynin chloride topical gel in older healthy subjects: a 1-week, randomized, double-blind, placebo- and active-controlled study.

Gary G Kay, David R Staskin, Scott MacDiarmid, Marilyn McIlwain, Naomi V Dahl

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00752141 (Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 21% 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.

NCT00752141 phase1completednot on this map

Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

TypeinterventionalSponsorWatson PharmaceuticalsRan2008Enrolled153ConditionsHealthy VolunteersArmsoxybutynin chloride immediate-release, oxybutynin chloride topical gel, placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Overactive bladder - 18 years - Part II.International braz j urol : official journal of the Brazilian Society of Urology
    Pooled it
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. CUA guideline on adult overactive bladder.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2017
    Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Gary G KayCognitive Research Corporation, St Petersburg, FL 33701, USA. gkay@cogres.com
David R Staskin
Scott MacDiarmid
Marilyn McIlwain
Naomi V Dahl
IBM Research - Thomas J. Watson Research Center · USCognitive Research (United States) · USTufts University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveOxybutynin is a common antimuscarinic therapy for overactive bladder. Transdermally administered oxybutynin chloride topical gel 10% (OTG) has a low propensity for anticholinergic adverse effects and possibly also a low risk of cognitive impairment. A randomized, double-blind, placebo- and active-controlled study evaluated the effects of OTG on cognitive and psychomotor functions in older healthy adults.

methodsHealthy adults aged 60-79 years were assigned randomly (1:1:1) to 1-week's treatment with OTG (1 g [100 mg oxybutynin] applied once daily on rotating sites of upper arms/shoulders, abdomen or thighs) plus oral placebo, immediate-release oxybutynin (OXB-IR; 5 mg capsule three times/day) plus placebo gel, or double placebo. Delayed recall Name-Face Association Test (NFAT) score was the primary end point. Treatments were compared by analysis of covariance.

resultsOf 152 participants (mean age, 68 years), 49 received OTG, 52 OXB-IR and 51 placebo. NFAT Delayed Recall tests revealed no significant treatment differences (overall, p = 0.2733; OTG vs placebo, p = 0.1551; OXB-IR vs placebo, p = 0.1767). However, a significant effect (p = 0.0294) was noted for the Misplaced Objects Test, with scores declining only for OXB-IR. Approximately twice as many participants receiving OXB-IR (n = 10) as those receiving OTG (n = 5) or placebo (n = 6) showed a significant decline (≥6 points) in Total Recall score for the Hopkins Verbal Learning Test-Revised. No significant effects on psychomotor reaction time were observed. The most common adverse event, dry mouth, occurred in 6.1%, 73.1% and 7.8% of participants receiving OTG, OXB-IR and placebo, respectively.

conclusionsOTG applied for 1 week had no clinically meaningful effect on recent memory or other cognitive functions in healthy, older adults. CLINICAL

trial registrationRegistered as NCT00752141 at www.clinicaltrials.gov.

Indexed as

Administration, TopicalAgedAttentionCognitionDouble-Blind MethodEndpoint DeterminationFemaleGelsHumansLearningMaleMandelic AcidsMemoryMental RecallMiddle AgedParasympatholyticsGelsMandelic AcidsoxybutyninParasympatholytics

Identifiers

PMID22909146
OpenAlexW2272230431

What OpenQuestion holds

Textmetadata
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.