Evidence map›Paper›PMID 31209699›Full record

Trial reportAdvances in therapy2019

Clinical and Psychological Outcomes of the Use of Vaginal Dilators After Gynaecological Brachytherapy: a Randomized Clinical Trial.

Taís Marques Cerentini, Júlia Schlöttgen, Patrícia Viana da Rosa, Valentina Lucia La Rosa, Salvatore Giovanni Vitale, Pierluigi Giampaolino, Gaetano Valenti, Stefano Cianci, Fabrício Edler Macagnan

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03090217 (Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer), which is not on this map. Cited by 13 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 5 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT03090217 naunknown statusnot on this map

Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial

TypeinterventionalSponsorFederal University of Health Science of Porto AlegreRan2017 to 2018Enrolled160ConditionsGynecologic Cancer, Pathological ConstrictionArmsPelvic Physiotherapy, Standard care (SC)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 5 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Review
  7. Review
  8. A physical therapy program to treat late-effect vaginal stenosis in gynecological cancer survivors: An interventional study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  9. Review
  10. Barriers to and facilitators of adherence to pelvic floor muscle exercises and vaginal dilator use among gynecologic cancer patients: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  11. Article
  12. Review
  13. Article
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

9 authors at 4 institutions in 2 countries.

Taís Marques CerentiniFederal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Júlia SchlöttgenFederal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Patrícia Viana da RosaFederal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Valentina Lucia La RosaUnit of Psychodiagnostics and Clinical Psychology, University of Catania, Catania, Italy.
Salvatore Giovanni VitaleDepartment of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy. sgvitale@unict.it.
Pierluigi GiampaolinoDepartment of Public Health, School of Medicine, University of Naples Federico II, Naples, Italy.
Gaetano ValentiDepartment of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.
Stefano CianciUnità Operativa Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Fabrício Edler MacagnanFederal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Universidade Federal de Ciências da Saúde de Porto Alegre · BRUniversity of Catania · ITAgostino Gemelli University Polyclinic · ITFederico II University Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this study was to evaluate the dimensions of the vaginal canal in patients undergoing gynaecological brachytherapy and the effect of the use of vaginal dilators (VD) used in the follow-up of pelvic physiotherapy.

methodsA total of 88 patients were randomly allocated to the control group (CG) and intervention group (IG). Three evaluations were performed: pre-brachytherapy, post-brachytherapy and follow-up of 3 months. The CG received standard guidance from the health team while the IG was instructed to use VD for 3 months. The dimensions of the vaginal canal (main outcome) were defined by the length of the vagina (centimetres), width (number of full clockwise turns of the opening thread of a gynaecological speculum) and area (defined by the size of the VD). Quality of life and pelvic floor (PF) functionality were also evaluated.

resultsThere was no effect of the VD on vaginal length, width and area among the intention-to-treat (ITT) population. However, in the analysis stratified by adhesion, the CG had a significant decrease in the vaginal area. PF was predominantly hypoactive throughout the follow-up. Quality of life improved in both groups, but the reduction of constipation, vaginal dryness and stress urinary incontinence manifested only in the IG.

conclusionThe use of VD did not alter the dimensions of the vaginal canal within the first 3 months after the end of radiotherapy treatment. However, there was a large sample loss during follow-up so studies with a larger sample number and longer follow-up time need to be conducted.

trial registrationClinicalTrials.gov Identifier NCT03090217.

Indexed as

AdultAgedAged, 80 and overBrachytherapyFemaleHumansMiddle AgedRadiotherapyUterine Cervical NeoplasmsVaginaCervical cancerPelvic physiotherapyRadiotherapyVaginal dilatorsWomen’s health

Identifiers

PMID31209699
PMCPMC6822871
OpenAlexW2949491608

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.