(Potential) Mishaps of High-Dose-Rate Vaginal Cuff Brachytherapy.

Considering how commonly vaginal cuff brachytherapy is used, there is relatively little literature regarding the potential, albeit low, risk for complications. We present 3 potentially serious mishaps involving cylinder misplacement, dehiscence, and excessive normal tissue irradiation due to unique anatomy. Three patients with potentially serious treatment errors were encountered in the authors' usual clinical practice. Each patient's records were reviewed for this report. For patient 1, computed tomography (CT) simulation revealed grossly inadequate cylinder insertion, which was most obvious on the sagittal view. For patient 2, CT simulation revealed that the cylinder extended beyond the perforated vaginal cuff and was surrounded by bowel. For patient 3, CT images were used only to verify cylinder depth. A standard library plan based on cylinder diameter and active length was used. In retrospect, the images revealed an unusually thin rectovaginal septum, with the lateral and posterior vaginal wall thickness estimated to be <2 mm. This patient's fractional normal tissue doses were calculated for this report, revealing a rectal maximum dose (per fraction) of 10.8 Gy, maximum dose that 2 cc of the organ receives of 7.4 Gy, and volume of the organ that receives the prescription dose or higher of 2.8 cc. All doses were far in excess of those anticipated for a minimal 0.5-cm vaginal wall depth. Vaginal cuff high-dose-rate brachytherapy is a high-volume, routine procedure. Even in experienced hands, however, it carries a risk of improper cylinder placement, cuff dehiscence, and excessive normal tissue dose, all of which could seriously affect outcomes. These potential mishaps would be better appreciated and avoided with more extensive use of CT-based quality assurance measures.

Significado do uso da prótese peniana de silicone no seguimento da braquiterapia pélvica / Significado do uso da prótese peniana de silicone no seguimento da braquiterapia pélvica / Meaning of the use of silicone penile prosthesis in the follow-up of pelvic brachytherapy

Objetivo: descrever o significado do uso da prótese peniana de silicone para dilatação vaginal no seguimento da braquiterapia em mulheres com câncer ginecológico. Método: pesquisa narrativa, realizada no Centro de Pesquisas Oncológicas, Brasil, com 34 mulheres, após braquiterapia pélvica, em seguimento no serviço de fisioterapia. Coleta de dados por entrevistas semiestruturadas, incluindo dados sociodemográficos, clínicos e o significado do uso da prótese peniana na dilatação vaginal, submetidas à análise de conteúdo e discutidas à luz do estudo From 'sex toy' to intrusive imposition. Resultados: o significado perpassa o exercício de dilatação vaginal; as dificuldades relacionadas às condições vaginais, doença, tratamento, dor, sexo, constrangimentos, preconceitos, falhas na educação em saúde; as motivações relacionam-se à busca por qualidade de vida, apoio dos companheiros e profissionais. Conclusão: a abordagem de possíveis barreiras emocionais, psicológicas, sociais e físicas deve ser planejada e executada para prevenção da estenose vaginal e melhor acolhimento.

Objective: to describe the meaning of the use of silicone penile prosthesis for vaginal dilation in the follow-up of brachytherapy in women with gynecological cancer. Method: narrative research conducted at the Centro de Pesquisas Oncológicas, Brazil, with 34 women after pelvic brachytherapy, under follow-up at the physical therapy service. Data collection through semi-structured interviews, including sociodemographic and clinical data and the significance of the use of penile prosthesis in vaginal dilation, submitted to content analysis and discussed in the light of the study From 'sex toy' to intrusive imposition. Results: the meaning permeates the vaginal dilation exercise; difficulties related to vaginal conditions, disease, treatment, pain, sex, constraints, prejudices, failures in health education; motivations are related to the search for quality of life, support of partners and professionals. Conclusion: the approach of possible emotional, psychological, social and physical barriers should be planned and executed for prevention of vaginal stenosis and better reception.

Objetivo: describir el significado del uso de una prótesis peneana de silicona para la dilatación vaginal posterior a la braquiterapia en mujeres con cáncer ginecológico. Método: investigación narrativa, realizada en el Centro de Pesquisas Oncológicas, Brasil, con 34 mujeres, después de braquiterapia pélvica, en seguimiento en el servicio de fisioterapia. Recopilación de datos a través de entrevistas semiestructuradas, incluyendo datos sociodemográficos y clínicos y el significado del uso de prótesis peneana en la dilatación vaginal, sometidos a análisis de contenido y discutidos a la luz del estudio From 'sex toy' to intrusive imposition. Resultados: el significado impregna el ejercicio de dilatación vaginal; dificultades relacionadas con condiciones vaginales, enfermedad, tratamiento, dolor, sexo, vergüenza, prejuicios, fallas en la educación para la salud; las motivaciones están relacionadas con la búsqueda de calidad de vida, apoyo de la pareja y profesionales. Conclusión: se debe planificar y ejecutar el abordaje de las posibles barreras emocionales, psicológicas, sociales y físicas para prevenir la estenosis vaginal y una mejor recepción.

Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial.

BACKGROUND: We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. METHODS: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. RESULTS: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). CONCLUSIONS: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.

The first major complication due to laser treatment for stress urinary incontinence: a short report.

AIM: Stress urinary incontinence (SUI) is a common benign disease causing a markedly negative impact on quality of life. Vaginal laser is a minimally invasive treatment and no major complications of this technique have been published to date. The purpose of the article is to present the first major adverse event related to this treatment. MATERIALS AND METHODS: We present the case of a 48-year-old woman with an important complication after vaginal laser for SUI. RESULTS: The patient presented a transverse vaginal septum and shortening of vaginal length after two sessions of vaginal erbium:yttrium aluminum garnet laser treatment. She required two surgical interventions, local injections, and pelvic floor physiotherapy, although currently the patient has not experienced complete resolution of symptoms. DISCUSSION AND CONCLUSIONS: Vaginal laser use can lead to serious adverse events. Selection of patients and treatment must be carried out with caution.

Vaginal necrosis: A rare late toxicity after radiation therapy.

Vaginal necrosis is a late radiation tissue injury with serious morbidity complications. It is rare, and its incidence is not well assessed in prospective trials. Patient comorbidities and radiation dose can significantly increase the risk. As treatment of gynecologic malignancies often involve a multidisciplinary approach, timely diagnosis and appropriate management by physicians of the team are crucial. Untreated vaginal necrosis can lead to infection, hemorrhage, necrosis-related fistulation to the bladder or rectum, perforation, and death. In this review, we describe the pathophysiology of vaginal necrosis, its clinical course, and management options.

LATE RADIATION TOXICITY AFTER RADICAL RADIOTHERAPY FOR GENITAL CANCER. / PIZNIa PROMENEVA TOKSYChNIST' PISLIa RADYKAL'NOÏ RADIOTERAPIÏ RAKU GENITALII.

Radiation therapy for malignant tumors of the female genital area, even with the use of modern radiotherapy equipment and dosimetric planning, causes the development of local radiation changes. An approach involving methodsof general and local exposure is used in their treatment. One of the most promising directions is the creation of optimal combinations of medicines (in the form of ointments, gels, aerosols, suppositories, etc.), which have a therapeutic effect on the inflammatory process. The article reflects the clinical course and stage of occurrence of late radiation reactions of the skin, vaginal/cervix mucosa, bladder, and intestines, as well as the features of their treatment.Literary data and own practical experience in the treatment of radiation complications are presented. Whenreviewing the topic under study, it could be concluded that the leading cause of the development of local radiationdamage is the errors in the planning and implementation of radiation therapy, when high absorbed doses thatexceed the tolerance of healthy tissues are used. Another reason for this is the poor accounting for dose distribution of ionizing radiation in tissues, the presence of concomitant diseases in patients, and the underestimation ofthe long-term effects of radiation.

At-Home Transvaginal Device Following Fractional Carbon Dioxide Laser Treatment for Genitourinary Syndrome of Menopause.

BACKGROUND: Device-based therapeutic approaches have been developed to treat women’s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment. OBJECTIVE: This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM). STUDY DESIGN: Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser). METHODS: 10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms. RESULTS: Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P<0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P<0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P<0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P<0.05). CONCLUSIONS: At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012.

A Systematic Review of Nonsurgical Vulvovaginal Restoration Devices: An Evidence-Based Examination of Safety and Efficacy.

BACKGROUND: The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that women are being harmed by laser and other energy-based devices. The goal of this systematic literature review was to assess existing data, determine gaps in evidence, and propose opportunities for continued investigation pertaining to laser and energy-based vaginal restoration techniques. METHODS: A review of literature using PubMed, Cochrane Library databases, Embase, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature was conducted on January 9, 2019, and articles up to this point were considered. For inclusion, studies had to be available or translated in English and relate to clinical medicine, direct patient care, and nonsurgical energy-based vulvovaginal procedures. RESULTS: The authors found five level I studies, 19 level II studies, four level III studies, and 46 level IV studies that used 15 different devices. Various degrees of improvement of symptoms were reported in all studies. Adverse events/side effects were noted in two of the 13 radiofrequency device studies, 15 of the 23 erbium:yttrium-aluminum-garnet device studies, and 17 of the 37 carbon dioxide device studies. The majority of adverse events were considered mild. CONCLUSIONS: The majority of studies resulted in mild to no adverse side effects. However, there is a large gap in level I evidence. As a result, the authors emphasize the necessity of supplemental data surrounding this subject and suggest that additional randomized sham-controlled studies be conducted to further investigate vulvovaginal restoration devices in an effort to address women's health issues.

Vaginal Dilator and Pelvic Floor Exercises for Vaginal Stenosis, Sexual Health and Quality of Life among Cervical Cancer Patients Treated with Radiation: Clinical Report.

This clinical report aimed to evaluate the effectiveness of the combination of vaginal dilator (VD) and pelvic floor muscle exercises (PFME) on vaginal stenosis, sexual health and quality of life among women undergoing radiotherapy treatment for cervical cancer; PFME were instructed prior to radiotherapy with six-month follow-up. An intention-to-treat analysis was performed for the 28 women. At four-months after radiotherapy, most of the women (90.9%) maintained/increased one size of the VD and were sexually active (81.8%). Adherence to VD was high. Regarding quality of life, there was more limitation in emotional functioning. VD and PFME were effective at preventing stenosis.

Comparison of vaginal microbiota in gynecologic cancer patients pre- and post-radiation therapy and healthy women.

BACKGROUND: While the importance of commensal microbes in vaginal health is well appreciated, little is known about the effects of gynecological cancer (GynCa) and radiation therapy (RT) on the vaginal microbiome (VM) of postmenopausal women. METHODS: We studied women with GynCa, pre- (N = 65) and post-RT (N = 25) and a group of healthy controls (N = 67) by sequencing the V4 region of the 16S rRNA gene from vaginal swabs and compared the diversity and composition of VMs between the three groups accounting for potential confounding factors in multivariate analysis of variance. RESULTS: Comparisons of cancer vs healthy groups revealed that Lactobacillus and Bifidobacterium have significantly higher relative abundance in the healthy group, while the cancer group was enriched in 16 phylogroups associated with bacterial vaginosis (BV) and inflammation, including Sneathia, Prevotella, Peptoniphilus, Fusobacterium, Anaerococcus, Dialister, Moryella, and Peptostreptococcus. In our sample, RT affected the α-diversity and correlated with higher abundance of typically rare VM species, including several members of the Lacnospiraceae family, a taxon previously linked to vaginal dysbiosis. In addition to cancer and treatment modalities, age and vaginal pH were identified as significant parameters that structure the VM. CONCLUSIONS: This is among the first reports identifying VM changes among postmenopausal women with cancer. RT alone seems to affect several phylogroups (12 bacterial genera), while gynecological cancer and its treatment modalities are associated with even greater significant shifts in the vaginal microbiota including the enrichment of opportunistic bacterial pathogens, which warrants further attention.

Management of radiation therapy-induced vaginal adhesions and stenosis: A New Zealand survey of current practice.

INTRODUCTION: Vaginal dilation is often indicated as an intervention for the management of radiation therapy-induced vaginal adhesions and stenosis (RTVAS). However, limited research exists underpinning this intervention and diversity in patient recommendations internationally are reported. In the absence of New Zealand (NZ) national guidelines regarding the management of RTVAS, a survey of NZ radiation therapy departments was conducted to gain an overview of current practice. METHODS: A two-section online survey was developed to capture RTVAS education and management overview across NZ. Section one focused on departmental resourcing and section two on local standard practice regarding vaginal dilator usage. One RTVAS education representative from each department was invited to complete the survey. RESULTS: Eight of nine NZ departments completed the survey. Consistent treatment indications were identified for RTVAS patient education with the involvement of diverse staffing groups at various time-points throughout the treatment process. Protocols for RTVAS management existed in each RT department with staff commonly trained by informal peer observation. Dilator usage was recommended regardless of patient sexual activity. Agreement was shown regarding the recommended start time of dilator usage and frequency. The recommended duration of dilator use post-treatment varied from 6 months to greater than 36 months. CONCLUSIONS: This work illustrates both concordance and diversity in practice and contributes to the limited body of literature available. Further research is warranted to explore patterns of practice between departmental protocols and individual practitioners in further detail.

Safety and mechanism of action of noninvasive radiofrequency treatment for vaginal laxity: Histological study in the swine vaginal model.

BACKGROUND: Structural changes in collagen and elastin fiber density have been previously evaluated by qualitative histological studies; however, quantitative evaluations are lacking. AIM: To evaluate quantitative changes in collagen and elastin fibers in the vaginal wall in a porcine model after volumetric radiofrequency heating with an intravaginal applicator. METHODS: An animal model was used (domestic pig, multipara: 5.67 ± 0.94 deliveries, 3 years of age). Three pigs under general anesthesia were treated (8-minute, vaginal canal area) once per week for the course of three weeks. There were 2 follow-up evaluations at one and four weeks. Histology specimens were obtained via punch biopsy under ultrasound control. Ultrasound video measurements of the vaginal wall thickness were also obtained. Tissue samples were stained by H&E as well as stains for collagen and elastin fibers. RESULTS: Elastin (P < .001) and collagen (P < .01) fiber density increased after every treatment. The measured increase in fibers was highest at the one-week follow-up. Elastin accounted on average for 51.46 ± 16.86% of the tissue examined (increase of 36.8% points), while collagen accounted on average for 44.83 ± 18.92% (increase of 17.1% points). The number of synthetically active cells was increased by 16%. While vaginal wall thickness did show an increase of 1.66 mm (32%), this tendency was not statistically significant (P > .05). CONCLUSION: Results suggest that volumetric heating of vaginal tissue produced quantitative improvement in the connective tissue organization in a porcine study. Neocollagenesis and neoelastogenesis were observed with an increased number of synthetically active cells.

Intravaginal energy-based devices and sexual health of female cancer survivors: a systematic review and meta-analysis.

A systematic review and meta-analysis was undertaken to assess the efficacy and safety of intravaginal energy-based therapies (laser and radiofrequency) on sexual health of cancer survivors (CS) (breast cancer (BCS) and/or gynecological cancer (GCS)). PubMed, Scopus, Web of Science, and Cochrane Library were searched until 21/02/2019. Quality of reporting, methodology, and body of evidence were assessed using STROBE, MINORS, and GRADE. Primary outcomes were dyspareunia, dryness, and sexual health (FSFI, FSDS-R). Secondary outcomes were burning, itching, dysuria, incontinence, Vaginal Health Index Score (VHIS), microbiome-cytokine evaluation, and adverse events. Main analyses, subgroup analyses, and sensitivity analyses were performed. Eight observational studies (n = 274) were eligible for inclusion. None of the studies evaluated radiofrequency. BCS and BCS-GCS were included in 87% and 13% of studies, respectively. All primary outcomes improved significantly with the exception of FSDS-R (dyspareunia (5 studies (n = 233), standardized mean difference (StdMD) (- 1.17), 95%CI [- 1.59, - 0.75]; p < 0.001; I2 = 55%), vaginal dryness (4 studies (n = 183), StdMD (- 1.98), 95%CI [- 3.31, - 0.65]; p = 0.003; I2 = 91%), FSFI (2 studies, n = 28, MD (12.79), 95%CI [7.69, 17.89]; p < 0.001; I2 = 0%). Itching, dysuria, and VHIS increased significantly, while burning was not improved. Serious adverse events were not observed by any of the studies. Intravaginal laser therapies appear to have a positive effect on dyspareunia, vaginal dryness, and FSFI of CS. However, the quality of evidence is "very low," with no data on intravaginal radiofrequency therapy. Further research with high-quality RCTs and long-term follow-up is needed to evaluate the value of energy-based devices as a therapeutic option for CS with sexual problems.

DW-MRI predictive factors for radiation-induced vaginal stenosis in patients with cervical cancer.

AIM: To find diffusion-weighted (DW) magnetic resonance imaging (MRI) parameters predictive for radiation-induced vaginal stenosis (VS) in locally advanced cervical cancer (LACC) treated with neoadjuvant chemoradiation therapy (CRT). MATERIALS AND METHODS: Retrospective analysis of 43 patients with LACC who underwent 1.5 T DW-MRI before (baseline), after 2 weeks (early), and at the end of CRT (final). At MRI, vaginal length, thickness, width, and cervical tumour volume (TV) were measured. Vaginal signal intensity at DW-MRI was analysed at final MRI. CRT-induced VS was graded using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Correlations between DW-MRI and clinical data were made using Wilcoxon's test, Mann-Whitney test, Fisher's exact test, or chi-squared test as appropriate. Receiver operating characteristic (ROC) curves were generated for variables to evaluate diagnostic ability to predict CRT-induced VS using a logistic regression model. RESULTS: Asymptomatic vaginal toxicity (CTCAE Grade 1) was observed in 14 patients and symptomatic CRT-induced VS (CTCAE Grade ≥2) was detected in 29 patients. Baseline TV was higher in Grade 1 than in Grade ≥2 (p=0.013). Median vaginal length, thickness, and width decreased between baseline and final MRI in all patients (p<0.0001) without significant variances between CTCAE grades. Significant differences were observed in DW-MRI patterns (p<0.0001). In Grade ≥2, DWI showed signal loss of vaginal mucosa in 17 patients (63%) and diffuse restricted diffusion of vaginal wall in eight patients (30%). AUC was 0.938 (coefficient=4.72; p<0.001) for DWI and 0.712 (coefficient=-2.623×10 -5; p=0.004) for TV. CONCLUSIONS: This is the first study using DW-MRI for predicting CRT-induced VS. DWI is useful tool in patients with LACC after CRT for early prevention and management strategies for VS.

Is one brachytherapy fraction of 7 Gy similar to more fractions after external beam irradiation in postoperative endometrial carcinoma?

PURPOSE: To determine whether brachytherapy with a single hypofractionated dose of 7 Gy provides the similar vaginal-cuff relapses and safety profile in terms of complications compared to schedules of 2 or 3 fractions of lower doses in patients treated previously with external beam irradiation in postoperative endometrial carcinoma. METHODS/MATERIAL: From June 2003 to December 2016, 325 patients were treated with 3 different schedules of high-dose-rate brachytherapy after external beam irradiation for postoperative endometrial carcinoma. The patients were divided into 3 groups: Group-1: 125 patients were treated with 3 fractions of 4-6 Gy per fraction (3 fractions/week) between 2003 and 2008; Group-2: 93 patients were treated with 2 consecutive daily fractions of 5-6 Gy between 2008 and 2011; Group-3: 107 patients received a single fraction of 7 Gy between 2011 and 2016. Bladder and rectum complications were assessed using RTOG scores and with the objective scores of LENT-SOMA for the vagina. STATISTICS: the chi-square test. RESULTS: The mean follow-up of Groups 1, 2 and 3 was 95, 67 and 51 months, respectively. Three patients in Group-1, 2 in Group-2, 1 in Group-3 developed vaginal-cuff relapse (p = 0.68). No differences were found in late toxicity among the three groups. CONCLUSIONS: One single dose of 7 Gy is safe and effective and may be the best treatment schedule with a similar incidence of vaginal-cuff relapses, complications and patient comfort with less hospital attendance.

Consensus for vaginal stenosis prevention in patients submitted to pelvic radiotherapy.

OBJECTIVE: To propose a consensus for prevention of vaginal stenosis in patients submitted to pelvic radiotherapy. METHOD: In this methodological study, Delphi technique was applied for content validation on vaginal stenosis prevention. Data regarding content validation were collected from 32 specialists practicing in the oncology profession. The content validity index of items in the consensus was calculated based on the evaluations by the specialists. RESULTS: In the first round, of the 38 items evaluated, 29 items reached a Content Validity Index (CVI-I) greater than 80%, and 9 items had a CVI lower than 80%. Of the items that did not obtain agreement, 2 items were excluded, and 7 were reformulated and included in the second round. In the second round, all 7 items obtained a CVI-I greater than 80%. The final instrument consisted of 29 items validated in the first round, plus 7 items reformulated and consolidated in the second round. The judges agreed that it is the responsibility of the health professionals to consult the patients undergoing radiation therapy in the area of sexuality to patients. The radiation oncologist should be the first professional to address this issue and the nurse oncologist in the follow-up consultation should pass the guidelines to the patients as comprehensively as possible. Patients should be informed about vaginal dilation, regardless of whether they are sexually active or have a partner. They should also be informed of when they can resume sexual activity. The procedure of vaginal dilation should be individualized. The prescribed vaginal dilators should be used with a lubricant for a duration of at least 5-10 minutes, 2-3 times a week, as per the need of each patient (sexual activity and/or clinical follow-up) for an indefinite time. Patients should seek medical help in case they experience pain, discomfort, or bleeding during dilation. CONCLUSION: The Brazilian version of the consensus for vaginal stenosis prevention in patients submitted to pelvic radiotherapy was validated with 36 items in 7 categories related to Responsibility; Target population; Rationale; Vaginal dilator; Content instructions; Information provision; and Patient support. In Brazil, the educational practices on vaginal dilation for patients submitted to radiotherapy partly revealed similar difficulties as identified in other studies as well as countries with reference to specific guidelines for the start and duration of vaginal dilation. The final consensus developed in this study could strengthen the guidelines for education of patients in Brazil and provide a future scope to establish a single and safe guideline.

Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology.

PURPOSE: Guidelines for the care of women undergoing pelvic radiation therapy (RT) recommend vaginal dilator therapy (VDT) to prevent radiation-induced vaginal stenosis (VS); however, no standard protocol exists. This review seeks to update our current state of knowledge concerning VS and VDT in radiation oncology. METHODS AND MATERIALS: A comprehensive literature review (1972-2017) was conducted using search terms "vaginal stenosis," "radiation," and "vaginal dilator." Information was organized by key concepts including VS definition, time course, pathophysiology, risk factors, and interventions. RESULTS: VS is a well-described consequence of pelvic RT, with early manifestations and late changes evolving over several years. Strong risk factors for VS include RT dose and volume of vagina irradiated. Resultant vaginal changes can interfere with sexual function and correlational studies support the use of preventive VDT. The complexity of factors that drive noncompliance with VDT is well recognized. There are no prospective data to guide optimal duration of VDT, and the consistency with which radiation oncologists monitor VS and manage its consequences is unknown. CONCLUSIONS: This review provides information concerning VS definition, pathophysiology, and risk factors and identifies domains of VDT practice that are understudied. Prospective efforts to monitor and measure outcomes of patients who are prescribed VDT are needed to guide practice.

Clinical Outcome of Exclusively Radiographer-led Delivery of Postoperative Vaginal Vault Brachytherapy for Endometrial Cancer - The Addenbrooke's Experience.

AIMS: Postoperative vaginal vault brachytherapy (VBT) reduces local recurrence in operable endometrial cancer. Radiographer-led delivery of VBT, carried out without image guidance, was implemented at Addenbrooke's in 2010 to maximise skills mix and to improve service delivery. The purpose of this study was to evaluate the safety and effectiveness of this service. MATERIALS AND METHODS: This was a single-centre retrospective study of endometrial cancer patients treated with postoperative high dose rate VBT ± external beam radiotherapy (EBRT) between January 2010 and December 2016. RESULTS: In total, 414 patients were analysed: 307 received adjuvant VBT alone and 107 patients received pelvic EBRT followed by VBT. Thirty-seven per cent of patients receiving VBT alone were high risk according to ESMO-ESGO-ESTRO criteria. After a median follow-up of 59 months (range 2-118), 9/414 (2.2%) patients had isolated vaginal recurrences, 15/414 (3.6%) had locoregional recurrence (vaginal, pelvic node or both), whereas 62/414 (15%) patients had distant recurrence. The 5-year actuarial isolated vaginal recurrence rate was 2.3% (VBT alone 2.1%, EBRT + VBT 3.0%). Grade 3 urinary or bowel toxicity occurred in 2/414 (0.6%) patients treated with EBRT and VBT. None of the patients treated with VBT alone had grade 3 complications. CONCLUSION: Radiographer-led delivery of VBT, without the use of image guidance, is a safe and effective service.

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

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.

Sex steroid hormone receptor expression in the vaginal wall in cervical cancer survivors after radiotherapy.

Background: Sex steroid hormones and their receptors are important in female sexual function. The aim of this study was to investigate the expression and distribution of estrogen receptor (ER)α, ERß, G-protein-coupled ER-1 (GPER), androgen receptor (AR), progesterone receptor (PR)A, PRB and connective tissue growth factor (CTGF) in the vaginal wall among women who had been treated for cervical cancer with radiotherapy. Material and methods: We included cervical cancer survivors treated with radiotherapy and premenopausal control women of the same age scheduled for benign gynecological surgery. We analyzed the expression and distribution of sex steroid hormone receptors and CTGF in biopsies from the vaginal wall, by real-time PCR and immunohistochemistry (IHC). Serum samples were analyzed for hormone levels and radiation dose at biopsy site were calculated and correlated to levels of the sex steroid hormone receptors. Results: In the cervical cancer survivors (n = 34), we found a lower expression of ERα at both mRNA and protein levels, compared to the control women (n = 37). In the survivors with high radiation dose at biopsy site, the immunostaining of ERα and AR was lower in the epithelium and the stroma, compared to survivors with minimal radiation dose. The later group showed expression of ERα comparable to the control women. The cancer survivors were sufficiently substituted with systemic estradiol with no difference in the serum estradiol levels compared to control women. Conclusions: We found that external radiation reduces the ERα and AR protein expression in the vaginal mucosa, indicating that the vaginal changes in irradiated cervical cancer survivors and the lack of response to hormonal treatment could be due to the decreases in sex steroid hormone receptor expression.