Evidence map›Paper›PMID 24947034›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2014

Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial.

David D Rahn, Meadow M Good, Shayzreen M Roshanravan, Haolin Shi, Joseph I Schaffer, Ravinder J Singh, R Ann Word

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 3% 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.

NCT03779633 phase4completednot on this mapstarted 2017, after this paper: background citation

Preoperative Locally Applied Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse: Changes in Subjective and Objective Outcome - a Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study

TypeinterventionalSponsorMedical University of ViennaRan2017 to 2020Enrolled120ConditionsPelvic Organ ProlapseArmsLinoladiol Estradiol, Placebo vaginal cream
NCT06969326 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy

TypeinterventionalSponsorWomen and Infants Hospital of Rhode IslandRan2025 to 2026Enrolled48ConditionsPostoperative Bleeding, Gender Dysphoria, HysterectomyArmsUse of topical estradiol, No intervention
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.

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  3. Preoperative promestriene for hysteroscopy: a randomized clinical trial.Revista da Associacao Medica Brasileira (1992) · 2024
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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

7 authors at 2 institutions in 1 country.

David D RahnDepartment of Obstetrics and Gynecology (D.D.R., M.M.G., S.M.R., H.S., J.I.S., R.A.W.), University of Texas Southwestern Medical Center, Dallas, Texas 75390-9032; and Department of Laboratory Medicine and Pathology (R.J.S.), Mayo Clinic, Rochester, Minnesota 55905.
Meadow M Good
Shayzreen M Roshanravan
Haolin Shi
Joseph I Schaffer
Ravinder J Singh
R Ann Word
The University of Texas Southwestern Medical Center · USMayo Clinic · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
Elastic Fiber Homeostasis in the Vaginal WallR01AG028048 · NIA · UT SOUTHWESTERN MEDICAL CENTER · PI WORD, RUTH A · 2007 to 2017
$3.2M
NCATS NIH HHS UL1 TR000135NIA NIH HHS AG028048NIA NIH HHS R01 AG028048
6 · The paper itself

Abstract

contextPelvic organ prolapse (POP) increases in prevalence with age; recurrence after surgical repair is common.

objectiveThe objective of the study was to determine the effects of local estrogen treatment on connective tissue synthesis and breakdown in the vaginal wall of postmenopausal women planning surgical repair of POP.

designThis was a randomized trial.

settingThe study was conducted at an academic tertiary medical center. PATIENTS OR OTHER

participantsPostmenopausal women with a uterus and symptomatic anterior and/or apical prolapse at stage 2 or greater participated in the study.

interventionEstrogen (Premarin) or placebo cream for 6 weeks preoperatively was the intervention.

main outcome measuresFull-thickness anterior apical vaginal wall biopsies were obtained at the time of hysterectomy and analyzed for mucosa and muscularis thickness, connective tissue synthesis, and degradation. Serum levels of estrone and 17β-estradiol were analyzed at baseline and the day of surgery using highly sensitive liquid chromatography-tandem mass spectrometry.

resultsFifteen women per group (n = 30 total) were randomized; 13 per group underwent surgery. Among drug-adherent participants (n = 8 estrogen, n = 13 placebo), epithelial and muscularis thickness was increased 1.8- and 2.7-fold (P = .002 and P =.088, respectively) by estrogen. Collagen types 1α1 and 1α2 mRNA increased 6.0- and 1.8-fold in the vaginal muscularis (P < .05 for both); collagen type Ia protein increased 9-fold in the muscularis (P = .012), whereas collagen III was not changed significantly. MMP-12 (human macrophage elastase) mRNA was suppressed in the vaginal mucosa from estrogen-treated participants (P = .011), and matrix metalloprotease-9 activity was decreased 6-fold in the mucosa and 4-fold in the muscularis (P = .02). Consistent with menopausal norms, serum estrone and 17β-estradiol were low and did not differ among the two groups.

conclusionsVaginal estrogen application for 6 weeks preoperatively increased synthesis of mature collagen, decreased degradative enzyme activity, and increased thickness of the vaginal wall, suggesting this intervention improves both the substrate for suture placement at the time of surgical repair and maintenance of connective tissue integrity of the pelvic floor.

Indexed as

PostmenopauseAdministration, IntravaginalBiopsyCollagenCollagenasesDouble-Blind MethodEstradiolEstrogensEstrogens, Conjugated (USP)EstroneFemaleFollow-Up StudiesHumansIntraoperative CareMedication AdherenceMiddle AgedCollagenCollagenasesEstradiolEstrogensEstrogens, Conjugated (USP)EstroneVaginal Creams, Foams, and Jellies

Identifiers

PMID24947034
PMCPMC4184065
OpenAlexW2121224475

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.