Evidence map›Paper›PMID 26945271›Full record

Trial reportFemale pelvic medicine & reconstructive surgery

Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment.

David Rich Ellington, Jeffery Michael Szychowski, Joseph Michael Malek, Kimberly Anne Gerten, Kathryn Larsen Burgio, Holly Elizabeth Richter

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Female pelvic medicine & reconstructive surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05221021 (Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.0field-weighted citation impact, top 10% 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.

NCT05221021 phase4recruitingnot on this map

Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial

TypeinterventionalSponsorWalter Reed National Military Medical CenterRan2022 to 2027Enrolled152ConditionsOveractive Bladder SyndromeArmsVaginal estrogen, Mirabegron 50 MG [Myrbetriq]
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 24 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

David Rich EllingtonFrom the *Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, and †Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL; ‡Urogynecology and Reconstructive Pelvic Surgery, Park Nicollet Health, St Louis Park, MN; and §Department of Medicine, University of Alabama at Birmingham; and Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Birmingham, AL.
Jeffery Michael Szychowski
Joseph Michael Malek
Kimberly Anne Gerten
Kathryn Larsen Burgio
Holly Elizabeth Richter
University of Alabama at Birmingham · US

Funding

Mid Career Award in Patient Oriented Pelvic Floor ResearchK24DK068389 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2005 to 2014
$1.7M
NIDDK NIH HHS K24 DK068389
6 · The paper itself

Abstract

objectivesThe aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder (OAB) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy.

methodsA single-site randomized, open-label trial in women with urinary frequency, urgency, nocturia, and/or urgency urinary incontinence symptoms was performed. Fifty-eight participants were randomized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week. The primary outcome was change in Overactive Bladder Questionnaire (OAB-q) symptom bother score at 12 weeks. Secondary outcomes included the Health-Related Quality of Life Questionnaire (HRQL) of the OAB-q and a 3-day bladder diary. At 12 weeks, subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks.

resultsThere was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks (20.6 ± 21.7, -15.8 ± 23.3, respectively, P = 0.45). There was a significant within-group decrease in symptom bother score from baseline to 12 weeks (tolterodine, P < 0.0001, and intravaginal estradiol, P = 0.002). Secondary outcome improvement within groups was noted in the HRQL total, urinary incontinence episodes, and median voiding frequency (all P ≤ 0.03) in the tolterodine group and in the HRQL total score (P = 0.03) in the intravaginal estradiol group, with no differences between groups. Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks (20.0 ± 23.9, P = 0.008; -16.7 ± 23.3, P = 0.02, respectively).

conclusionsSignificant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms, with no difference between groups. Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol. The role of combined medical therapy for OAB symptoms needs further investigation.

Indexed as

Administration, IntravaginalAdministration, OralAgedDelayed-Action PreparationsDrug CombinationsEstradiolEstrogensFemaleHumansMiddle AgedMuscarinic AntagonistsQuality of LifeSurveys and QuestionnairesTime FactorsTolterodine TartrateTreatment OutcomeDelayed-Action PreparationsDrug CombinationsEstradiolEstrogensMuscarinic AntagonistsTolterodine Tartrate

Identifiers

PMID26945271
PMCPMC4919279
OpenAlexW2292947259

What Socratic 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 Socratic graph.