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, 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

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.

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)

References

    1. IARC–WHO . In: World cancer report 2014. Stewart B, Wild C, editors. Lyon: International Agency for Research on Cancer; 2014.
    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.
    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.
    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.
    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.
    1. Vitale SG, Capriglione S, Zito G, et al. Management of endometrial, ovarian and cervical cancer in the elderly: current approach to a challenging condition. Arch Gynecol Obstet. 2019;299:299–315. doi: 10.1007/s00404-018-5006-z.
    1. Izycki D, Woźniak K, Izycka N. Consequences of gynecological cancer in patients and their partners from the sexual and psychological perspective. Prz Menopauzalny. 2016;15:112–116.
    1. Zomkowski K, Toryi AM, Sacomori C, Dias M, Sperandio FF. Sexual function and quality of life in gynecological cancer pre- and post-short-term brachytherapy: a prospective study. Arch Gynecol Obstet. 2016;294:833–840. doi: 10.1007/s00404-016-4099-5.
    1. Kokka F, Bryant A, Brockbank E, Powell M, Oram D. Hysterectomy with radiotherapy or chemotherapy or both for women with locally advanced cervical cancer. Cochrane Database Syst Rev. 2015;(4):CD010260.
    1. Marth C, Landoni F, Mahner S, McCormack M, Gonzalez-Martin A, Colombo N. Cervical cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(Supplement 4):iv262. doi: 10.1093/annonc/mdy160.
    1. Bohr Mordhorst L, Karlsson L, Bärmark B, Sorbe B. Combined external and intracavitary irradiation in treatment of advanced cervical carcinomas: predictive factors for treatment outcome and early and late radiation reactions. Int J Gynecol Cancer. 2014;24:1268–1275. doi: 10.1097/IGC.0000000000000208.
    1. Wolf JK. Prevention and treatment of vaginal stenosis resulting from pelvic radiation therapy. Community Oncol. 2006;3:665–671. doi: 10.1016/S1548-5315(11)70917-2.
    1. Mouttet-Audouard R, Lacornerie T, Tresch E, et al. What is the normal tissues morbidity following helical intensity modulated radiation treatment for cervical cancer? Radiother Oncol. 2015;115:386–391. doi: 10.1016/j.radonc.2015.02.010.
    1. Delanian S, Lefaix JL. The radiation-induced fibroatrophic process: therapeutic perspective via the antioxidant pathway. Radiother Oncol. 2004;73:119–131. doi: 10.1016/j.radonc.2004.08.021.
    1. Bruner DW, Nolte S, Shahin MS, et al. Measurement of vaginal length: reliability of the vaginal sound—a Gynecologic Oncology Group study. Int J Gynecol Cancer. 2006;16:1749–1755. doi: 10.1111/j.1525-1438.2006.00711.x.
    1. Lee Y. Patients’ perception and adherence to vaginal dilator therapy: a systematic review and synthesis employing symbolic interactionism. Patient Prefer Adherence. 2018;12:551–560. doi: 10.2147/PPA.S163273.
    1. Mohamed S, Lindegaard JC, de Leeuw AAC, et al. Vaginal dose de-escalation in image guided adaptive brachytherapy for locally advanced cervical cancer. Radiother Oncol. 2016;120:480–485. doi: 10.1016/j.radonc.2016.05.020.
    1. Lancaster L. Preventing vaginal stenosis after brachytherapy for gynaecological cancer: an overview of Australian practices. Eur J Oncol Nurs. 2004;8:30–39. doi: 10.1016/S1462-3889(03)00059-0.
    1. Park HS, Ratner ES, Lucarelli L, Polizzi S, Higgins SA, Damast S. Predictors of vaginal stenosis after intravaginal high-dose-rate brachytherapy for endometrial carcinoma. Brachytherapy. 2015;14:464–470. doi: 10.1016/j.brachy.2015.03.001.
    1. Hofsjö A, Bohm-Starke N, Blomgren B, Jahren H, Steineck G, Bergmark K. Radiotherapy-induced vaginal fibrosis in cervical cancer survivors. Acta Oncol. 2017;56:661–666. doi: 10.1080/0284186X.2016.1275778.
    1. Kirchheiner K, Nout RA, Lindegaard JC, et al. Dose-effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study. Radiother Oncol. 2016;118:160–166. doi: 10.1016/j.radonc.2015.12.025.
    1. Bakker RM, Vermeer WM, Creutzberg CL, Mens JWM, Nout RA, Ter Kuile MM. Qualitative accounts of patients’ determinants of vaginal dilator use after pelvic radiotherapy. J Sex Med. 2015;12:764–773. doi: 10.1111/jsm.12776.
    1. Bergin R, Hocking A, Robinson T, et al. Continuing variation and barriers to nurse-led vaginal dilator education for women with gynaecological cancer receiving radiotherapy. Eur J Oncol Nurs. 2016;24:20–21. doi: 10.1016/j.ejon.2016.08.001.
    1. Miles T, Johnson N. Vaginal dilator therapy for women receiving pelvic radiotherapy. Cochrane Database Syst Rev. 2010;(9):CD007291.
    1. Cullen K, Fergus K, DasGupta T, et al. Toward clinical care guidelines for supporting rehabilitative vaginal dilator use with women recovering from cervical cancer. Support Care Cancer. 2013;21:1911–1917. doi: 10.1007/s00520-013-1726-6.
    1. Cullen K, Fergus K, Dasgupta T, Fitch M, Doyle C, Adams L. From “sex toy” to intrusive imposition: a qualitative examination of women’s experiences with vaginal dilator use following treatment for gynecological cancer. J Sex Med. 2012;9:1162–1173. doi: 10.1111/j.1743-6109.2011.02639.x.
    1. Morris L, Do V, Chard J, Brand AH. Radiation-induced vaginal stenosis: current perspectives. Int J Womens Health. 2017;9:273–279. doi: 10.2147/IJWH.S106796.
    1. Loyd J, Crouch NS, Minto CL, Liao LM. Creighton female genital appearance: “normality” unfolds. BJOG. 2005;112:643–646. doi: 10.1111/j.1471-0528.2004.00517.x.
    1. Bernards AT, Berghmans BC, Slieker-Ten Hove MC, Staal JB, de Bie RA, Hendriks EJ. Dutch guidelines for physiotherapy in patients with stress urinary incontinence: an update. Int Urogynecol J. 2014;25:171–179. doi: 10.1007/s00192-013-2219-3.
    1. Messelink B, Benson T, Berghmans B, et al. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24:374–380. doi: 10.1002/nau.20144.
    1. de Filho MR, Rocha BA, de Pires MB, et al. Quality of life of patients with head and neck cancer. Braz J Otorhinolaryngol. 2013;79:82–88. doi: 10.5935/1808-8694.20130014.
    1. Law E, Kelvin JF, Thom B, et al. Prospective study of vaginal dilator use adherence and efficacy following radiotherapy. Radiother Oncol. 2015;116:149–155. doi: 10.1016/j.radonc.2015.06.018.
    1. Ely GE, White C, Jones K, et al. Cervical cancer screening: exploring Appalachian patients’ barriers to follow-up care. Soc Work Health Care. 2014;53:83–95. doi: 10.1080/00981389.2013.827149.
    1. Wordlaw-Stinson L, Jones S, Little S, et al. Challenges and recommendations to recruiting women who do not adhere to follow-up gynecological care. Open J Prev Med. 2014;04:123–128. doi: 10.4236/ojpm.2014.43017.
    1. Rutledge TL, Rogers R, Lee SJ, Muller CY. A pilot randomized control trial to evaluate pelvic floor muscle training for urinary incontinence among gynecologic cancer survivors. Gynecol Oncol. 2014;132:154–158. doi: 10.1016/j.ygyno.2013.10.024.
    1. Carter J, Stabile C, Seidel B, Baser RE, Goldfarb S, Goldfrank DJ. Vaginal and sexual health treatment strategies within a female sexual medicine program for cancer patients and survivors. J Cancer Surviv. 2017;11:274–283. doi: 10.1007/s11764-016-0585-9.
    1. Kirchheiner K, Czajka-Pepl A, Ponocny-Seliger E, et al. Posttraumatic stress disorder after high-dose-rate brachytherapy for cervical cancer with 2 fractions in 1 application under spinal/epidural anesthesia: incidence and risk factors. Int J Radiat Oncol Biol Phys. 2014;89:260–267. doi: 10.1016/j.ijrobp.2014.02.018.
    1. Pfaendler KS, Wenzel L, Mechanic MB, Penner KR. Cervical cancer survivorship: long-term quality of life and social support. Clin Ther. 2015;37:39–48. doi: 10.1016/j.clinthera.2014.11.013.
    1. van Leeuwen M, Husson O, Alberti P, et al. Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire. Health Qual Life Outcomes. 2018;16:114. doi: 10.1186/s12955-018-0920-0.
    1. Ramaseshan AS, Felton J, Roque D, Rao G, Shipper AG, Sanses TVD. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459–476.
    1. Lind H, Waldenström AC, Dunberger G, et al. Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort study. Br J Cancer. 2011;105:737–745. doi: 10.1038/bjc.2011.315.
    1. Velaskar Shruti M, Martha R, Mahantashetty U, Badakare JS, Shrivastava SK. Use of indigenous vaginal dilator in radiation induced vaginal stenosis. Indian J Occup Ther. 2007;39:3–6.
    1. Bahng AY, Dagan A, Bruner DW, Lin LL. Determination of prognostic factors for vaginal mucosal toxicity associated with intravaginal high-dose rate brachytherapy in patients with endometrial cancer. Int J Radiat Oncol Biol Phys. 2012;82:667–673. doi: 10.1016/j.ijrobp.2010.10.071.
    1. Martins J, Vaz AF, Grion RC, Esteves SCB, Costa-Paiva L, Baccaro LF. Factors associated with changes in vaginal length and diameter during pelvic radiotherapy for cervical cancer. Arch Gynecol Obstet. 2017;296:1125–1133. doi: 10.1007/s00404-017-4553-z.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir