Evidence map›Paper›PMID 38178267›Full record

ArticlePilot and feasibility studies2024

Comparative effectiveness of pelvic floor muscle training, mirabegron, and trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study.

Steve R Fisher, Alejandro Villasante-Tezanos, Lindsay M Allen, Monique R Pappadis, Gokhan Kilic

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05880862 (Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.4field-weighted citation impact, top 13% 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.

NCT05880862 early_phase1completednot on this map

Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study

TypeinterventionalSponsorThe University of Texas Medical Branch, GalvestonRan2023 to 2025Enrolled48ConditionsUrinary Bladder, Overactive, Urinary Incontinence, Accidental FallsArmsPelvic Floor Muscle Training, Mirabegron, Trospium Chloride
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Review
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 1 institution in 1 country.

Steve R FisherDepartment of Physical Therapy, University of Texas Medical Branch at Galveston, Galveston, USA. stfisher@utmb.edu.ORCID http://orcid.org/0000-0002-5685-3227
Alejandro Villasante-TezanosOffice of Biostatistics, University of Texas Medical Branch at Galveston, Galveston, USA.
Lindsay M AllenDepartment of Physical Therapy, University of Texas Medical Branch at Galveston, Galveston, USA.
Monique R PappadisDepartment of Population Health and Health Disparities, University of Texas Medical Branch at Galveston, Galveston, USA.
Gokhan KilicDepartment of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, USA.
The University of Texas Medical Branch at Galveston · US

Funding

Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF TrialR01AG078153 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI KITZMAN, DALANE W · 2022 to 2025
$26.6M
Comparative effectiveness of pelvic floor muscle training, Mirabegron, and Trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study.R21AG081900 · NIA · UNIVERSITY OF TEXAS MED BR GALVESTON · PI FISHER, STEVEN R · 2023 to 2024
$426k
NIA NIH HHS R01 AG078153NIA NIH HHS R21 AG078153NIA NIH HHS R21 AG081900
6 · The paper itself

Abstract

backgroundUntreated, urgency urinary incontinence (UUI) and overactive bladder (OAB) can precipitate a vicious cycle of decreasing physical activity, social isolation, fear of falling, and falls. Structured behavioral interventions and medications are common initial treatment options, but they elicit their effects through very different mechanisms of action that may influence fall-related outcomes differently. This study will determine the feasibility of conducting a comparative effectiveness, three-arm, mixed methods, randomized clinical trial of a behaviorally based pelvic floor muscle training (PFMT) intervention versus two recent drug options in older women with UUI or OAB who are also at increased risk of falling.

methodsForty-eight women 60 years and older with UUI or OAB who screen positive for increased fall risk will be recruited through the urogynacology and pelvic health clinics of our university health system. Participants will be randomly assigned to one of three 12-week treatment arms: (1) a course of behavioral and pelvic floor muscle training (PFMT) provided by physical therapists; (2) the beta-3 agonist, mirabegron; and (3) the antimuscarinic, trospium chloride. Study feasibility will be established through objective metrics of evaluability, adherence to the interventions, and attrition. We will also assess relevant measures of OAB symptom severity, quality of life, physical activity, incident falls, and concern about falling. DISCUSSION: The proposed research seeks to ultimately determine if linkages between reduction in UI symptoms through treatment also reduce the risk of falling in this patient population.

trial registrationNCT05880862. Registered on 30 May 2023.

Indexed as

FallsOveractive bladderUrinary incontinence

Identifiers

PMID38178267
PMCPMC10765875
OpenAlexW4390585186

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.