Evidence map›Paper›PMID 32912971›Full record

Trial reportBMJ open2020

Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial.

Tina Sara Verghese, Lee Middleton, Versha Cheed, Lisa Leighton, Jane Daniels, Pallavi Manish Latthe, LOTUS trial collaborative group

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 20% 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

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Urinary Incontinence and Pelvic Organ Prolapse in Women.Deutsches Arzteblatt international · 2023
    Review
  7. 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 4 institutions in 1 country.

Tina Sara VergheseInstitute of Metabolism and System Research, University of Birmingham, Birmingham, UK t.s.verghese@bham.ac.uk.ORCID 0000-0003-3880-6416
Lee MiddletonSchool of Health and Population Sciences, University of Birmingham, Birmingham, UK.
Versha CheedBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.ORCID 0000-0002-6713-0913
Lisa LeightonBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Jane DanielsNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Pallavi Manish LattheObstetrics and Gynaecology, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.
LOTUS trial collaborative group
Cancer Research UK Clinical Trials Unit · GBUniversity of Birmingham · GBBirmingham Women’s and Children’s NHS Foundation Trust · GBUniversity of Nottingham · GB

Funding

Department of Health PB-PG-0213-30126
6 · The paper itself

Abstract

objectiveTo evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery. DESIGN AND

settingA randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015-August 2016).

participantsPostmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.

interventionWomen were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery. OUTCOME MEASURES: The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.

results325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.

conclusionsA large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation. TRIAL REGISTRATION NUMBER: ISRCTN46661996.

Indexed as

Pelvic Organ ProlapseAgedEstrogensFeasibility StudiesFemaleHumansMiddle AgedPilot ProjectsPostmenopauseEstrogensfeasibilityoestrogenpelvic organ prolapsepilotpostmenopausalrecurrence

Identifiers

PMID32912971
PMCPMC7485245
OpenAlexW3085404464

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.