Evidence map›Paper›PMID 35421017›Full record

Trial reportFemale pelvic medicine & reconstructive surgery2022

Feasibility and Research Insights From a Randomized Controlled Trial for Recurrent Urinary Tract Infection Prevention in Postmenopausal Women Using Vaginal Estrogen Therapy.

Stacy M Lenger, Christine M Chu, Chiara Ghetti, Michael J Durkin, Zoe Jennings, Siobhan Sutcliffe, Jerry L Lowder

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Female pelvic medicine & reconstructive surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

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

7 authors at 2 institutions in 1 country.

Stacy M Lenger
Christine M ChuDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine.
Chiara GhettiDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine.
Michael J DurkinDivision of Infectious Diseases, Department of Internal Medicine.
Zoe JenningsDivision of Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine.
Siobhan Sutcliffe
Jerry L LowderDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington University School of Medicine.
Institute for Female Pelvic Medicine and Reconstructive Surgery · USWashington University in St. Louis · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI AIMEE S JAMES · 2001 to 2026
$128.0M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Washington University Institute of Clinical and Translational Sciences (KL2) KL2TR002346 · NCATS · WASHINGTON UNIVERSITY · PI Dominic N Reeds · 2017 to 2026
$14.0M
Using Implementation Science and Informatics to Develop and Pilot Test Antibiotic Stewardship Clinical Decision SupportK23DE029514 · NIDCR · WASHINGTON UNIVERSITY · PI DURKIN, MICHAEL JOSEPH · 2021 to 2025
$632k
NCATS NIH HHS KL2 TR002346NCATS NIH HHS UL1 TR002345NCI NIH HHS P30 CA091842NIDCR NIH HHS K23 DE029514
6 · The paper itself

Abstract

objectiveThe aim of the study was to inform feasibility parameters (eligibility, enrollment, and retention) for a recurrent urinary tract infection (rUTI) prevention randomized controlled trial (RCT).

methodsWe assessed feasibility parameters of an RCT of postmenopausal women with uncomplicated rUTIs using vaginal estrogen. Participants were randomized to either d-mannose or a control arm. All participants were required to be using vaginal estrogen and to have a negative urine culture before 90-day trial participation. An RCT exit survey and separate survey for UTI patients (N = 196) were added to inform feasibility parameters and patient preferences for rUTI prevention and study participation after slower enrollment than anticipated.

resultsAt the time of interim and subsequent futility analyses, 545 patients had been evaluated for frequent/recurrent UTIs from March 1, 2018, to January 18, 2020. Of these, 213 (39.1%) had culture-proven rUTIs and 71 (33.3% of those with culture-proven rUTIs) were eligible for the RCT. Reasons for ineligibility included complicated UTIs, premenopausal/perimenopausal status, or existing UTI prevention regimen. Of the 71 eligible participants, 57 (80.3%) enrolled, and 44 began their planned 90-day study period (77.2%; 80.0% after excluding 2 participants awaiting negative urine cultures at the time of analysis). The study was halted before conclusion. Study retention (76.0%-83.7%) was slightly lower than expected. Urinary tract infection survey patients demonstrated significant interest in rUTI research participation.

conclusionsWe learned several important lessons that can benefit future research. Many patients with frequent/recurrent UTIs are interested in research, but rigorous eligibility criteria and referral urine culture documentation made recruitment challenging.

Indexed as

PostmenopauseUrinary Tract InfectionsEstrogensFeasibility StudiesFemaleHumansRecurrenceVaginaEstrogens

Identifiers

PMID35421017
PMCPMC9232865
OpenAlexW4224118356

What OpenQuestion holds

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LicenceTDM
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.