Evidence map›Paper›PMID 32541299›Full record

ArticleFemale pelvic medicine & reconstructive surgery2021

Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Recurrence of the Vagina using Estrogen: IMPROVE).

David D Rahn, Holly E Richter, Vivian W Sung, Wilma I Larsen, Linda S Hynan

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Female pelvic medicine & reconstructive surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02431897 (Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT02431897 phase4completednot on this map

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2016 to 2023Enrolled206ConditionsPelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, CystoceleArmsConjugated Estrogens Cream, Placebo Cream
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. 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 4 institutions in 1 country.

David D RahnFrom the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.
Holly E RichterDepartment of Obstetrics and Gynecology, University of Alabama, Birmingham, AL.
Vivian W SungDepartment of Obstetrics and Gynecology, Alpert Medical School of Brown University/Women and Infants Hospital of Rhode Island, Providence, RI.
Wilma I LarsenDepartment of Obstetrics and Gynecology, Baylor Scott and White Memorial Hospital, Temple TX.
Linda S HynanDepartments of Population and Data Sciences and Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX.
Brown University · USScott & White Memorial Hospital · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · US

Funding

Investigation to Minimize Prolapse Recurrence Of the Vagina using Estrogen (IMPROVE)R01AG047290 · NIA · UT SOUTHWESTERN MEDICAL CENTER · PI RAHN, DAVID DWIGHT · 2015 to 2019
$2.5M
NIA NIH HHS R01 AG047290
6 · The paper itself

Abstract

objectivesTo provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair.

methodsStudy population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence.

resultsRecruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit.

conclusionsThis trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.

Indexed as

Randomized Controlled Trials as TopicDouble-Blind MethodEstrogensFemaleGynecologic Surgical ProceduresHumansPelvic Organ ProlapsePreoperative PeriodVaginaVaginal Creams, Foams, and JelliesEstrogensVaginal Creams, Foams, and Jellies

Identifiers

PMID32541299
PMCPMC7769931
OpenAlexW3035633436

What OpenQuestion 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 OpenQuestion graph.