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Randomized Controlled Trial
. 2019 Aug;36(8):1936-1949.
doi: 10.1007/s12325-019-01006-4. Epub 2019 Jun 17.

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

Taís Marques Cerentini  1 , Júlia Schlöttgen  1 , Patrícia Viana da Rosa  1 , Valentina Lucia La Rosa  2 , Salvatore Giovanni Vitale  3 , Pierluigi Giampaolino  4 , Gaetano Valenti  5 , Stefano Cianci  6 , Fabrício Edler Macagnan  1
Affiliations
Randomized Controlled Trial

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

Taís Marques Cerentini et al. Adv Ther. 2019 Aug.

Abstract

Introduction: The 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.

Methods: A 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.

Results: There 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.

Conclusion: The 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 registration: ClinicalTrials.gov Identifier NCT03090217.

Keywords: Cervical cancer; Pelvic physiotherapy; Radiotherapy; Vaginal dilators; Women’s health.

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Conflict of interest statement

Salvatore Giovanni Vitale is a member of the journal's Editorial Board. Valentina Lucia La Rosa is a member of the journal's Editorial Board. Taís Marques Cerentini, Júlia Schlöttgen, Patrícia Viana da Rosa, Pierluigi Giampaolino, Gaetano Valenti, Stefano Cianci and Fabrício Edler Macagnan have nothing to disclose.

Figures

Fig. 1
Fig. 1
Study protocol flow chart
Fig. 2
Fig. 2
Study period flow chart
Fig. 3
Fig. 3
Dimensions of the vaginal canal: a length (cm), b width (rollbacks) and c area (cm2)
See this image and copyright information in PMC

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References

    1. IARC–WHO . In: World cancer report 2014. Stewart B, Wild C, editors. Lyon: International Agency for Research on Cancer; 2014. - PubMed
    1. Vitale SG, Valenti G, Rapisarda AMC, et al. P16INK4a as a progression/regression tumour marker in LSIL cervix lesions: our clinical experience. Eur J Gynaecol Oncol. 2016;37:685–688. - PubMed
    1. Bakker RM, Mens JWM, de Groot HE, et al. A nurse-led sexual rehabilitation intervention after radiotherapy for gynecological cancer. Support Care Cancer. 2017;25:729–737. doi: 10.1007/s00520-016-3453-2. - DOI - PMC - PubMed
    1. Rossetti D, Vitale SG, Tropea A, Biondi A, Laganà AS. New procedures for the identification of sentinel lymph node: shaping the horizon of future management in early stage uterine cervical cancer. Updates Surg. 2017;69:383–388. doi: 10.1007/s13304-017-0456-6. - DOI - PubMed
    1. Jeppesen MM, Mogensen O, Dehn P, Jensen PT. Needs and priorities of women with endometrial and cervical cancer. J Psychosom Obstet Gynaecol. 2015;36:122–132. doi: 10.3109/0167482X.2015.1059417. - DOI - PubMed

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