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Practical Radiation Oncology Nov 2019Guidelines for the care of women undergoing pelvic radiation therapy (RT) recommend vaginal dilator therapy (VDT) to prevent radiation-induced vaginal stenosis (VS);... (Review)
Review
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.
Topics: Constriction, Pathologic; Dilatation; Female; Humans; Radiation Oncology; Vagina
PubMed: 31302301
DOI: 10.1016/j.prro.2019.07.001 -
Ecancermedicalscience 2023To investigate the compliance and clinical efficacy of vaginal dilators (VDs) as an educational intervention in patients receiving pelvic radiation therapy (RT) for...
OBJECTIVE
To investigate the compliance and clinical efficacy of vaginal dilators (VDs) as an educational intervention in patients receiving pelvic radiation therapy (RT) for endometrial and cervical malignancies.
MATERIAL AND METHODS
This is a single institution, retrospective chart review. Patients undergoing pelvic RT for endometrial or cervical cancer at our center were educated about the use of a VD starting 1 month after completion of RT. The patients were assessed after 3 months of prescribing VD. The demographic details and physical examination findings were extracted from medical records.
RESULTS
We identified 54 female patients at our institution during the 6-month duration. The median mean age of patients was 54 ± 9.9 years. Twenty-four (44.4%) had endometrial cancers and 30 (55.6%) were diagnosed with cervical cancers. All patients received external beam RT, 38 (70.4%) received a dose of 45 Gy, and 16 (29.6%) patients received 50.4 Gy. Brachytherapy was also received by all patients, 28 (51.9%) received 5 Gy × 2 fractions, 4 (7.4%) received 7 Gy × 3 fractions and 22 (40.7%) received 8 Gy × 3 fractions. The compliance with VD use was 36 (66.6%) patients. Twenty-two (40.7%) used 2-3 times a week, 8 (14.8%) used <2 times per week and 6 (11.9%) used only once a month, and 18 (33.3%) did not use the VD post-treatment. Per vaginal (PV) examination findings of the patient's vagina with normal mucosa were evaluated in 32 (59.3%) and adhesions were found in 20 (37.0%) and 2 (3.7%) were unable to examine due to dense adhesions. During examination 12 (22.2%) had bleeding PV, however, the majority of the patients, 42 (77.8%) experienced no bleeding PV. Out of the 36 patients who used a VD, it was found to be efficacious in 29 (80.6%) of patients. Upon stratification of efficacy with a frequency of VD, 72.4% ( = 21) efficacy was seen in patients using frequent VD as prescribed 2-3 times per week.
CONCLUSION
The compliance and efficacy of VD use after radiation to pelvic in cervical and endometrial cancers at 3 months follow-up were found to be 66.6% and 80.6%, respectively. This shows that VD therapy is an effective interventional tool and patients should receive specialist education about vaginal stenosis as toxicity at the outset of treatment.
PubMed: 37377680
DOI: 10.3332/ecancer.2023.1545 -
The Journal of Sexual Medicine Oct 2023Vaginoplasty is a gender-affirming surgery that is medically necessary for some transfeminine individuals. Little research exists describing vaginal health after the...
BACKGROUND
Vaginoplasty is a gender-affirming surgery that is medically necessary for some transfeminine individuals. Little research exists describing vaginal health after the initial recovery from surgery, and evidence-based guidelines for vaginal care practices are unavailable.
AIM
The study sought to describe self-reported gynecological concerns and vaginal care practices among transfeminine persons who have undergone vaginoplasty.
METHODS
A total of 60 transfeminine participants 18+ years of age, living in Canada, and who had undergone vaginoplasty at least 1 year prior were recruited through social media, community groups, healthcare provider referrals, and study recontact. Participants completed a cross-sectional, online questionnaire detailing demographics, gynecological concerns, and genital practices and exposures. Hierarchical clustering was used to group participants based on behavioral practices and exposures. Associations between clusters and gynecological concerns were assessed.
OUTCOMES
Outcomes included self-reported gynecological concerns within the past year, recent vulvar or vaginal symptoms (past 30 days), and behavioral practices/exposures, including douching with varied products and dilating.
RESULTS
Participants reported a variety of concerns in the past year, including urinary tract infection (13%) and internal hair regrowth (23%). More than half (57%) had experienced at least 1 recent vaginal symptom, most commonly malodor (27%) and vaginal bleeding (21%). Of participants, 48% were dilating weekly and 52% reported douching in the past 30 days. Four distinct clusters of vaginal practices/exposures were identified: limited exposures; dilating, no douching; dilating and douching; and diverse exposures. No significant associations between cluster membership and gynecological concerns were identified, though cluster membership was significantly associated with surgical center (P = .03). Open-text write-ins provided descriptions of symptoms and symptom management strategies.
CLINICAL IMPLICATIONS
The results provide insight for clinicians on common patient-reported gynecological concerns and current vaginal care practices and exposures, including symptom management strategies.
STRENGTHS AND LIMITATIONS
This was the first study to investigate vaginal health and genital practices/exposures among a community sample of transfeminine individuals. As participants self-enrolled for a detailed survey and swab collection, individuals experiencing concerns were likely overrepresented.
CONCLUSION
Transfeminine individuals reported a range of gynecological concerns outside of the surgical healing period. Genital practices/exposures varied across clusters, but no clear associations between clusters and symptoms were identified; instead, practice/exposure clusters were dependent on where the individual underwent vaginoplasty. There is a need for evidence to inform diagnostics, treatments, and vaginal care guidelines to support vaginal health.
Topics: Female; Humans; Transgender Persons; Cross-Sectional Studies; Transsexualism; Vagina; Sex Reassignment Surgery
PubMed: 37700562
DOI: 10.1093/jsxmed/qdad109 -
Materials (Basel, Switzerland) Feb 2024There are more than 13,000 new cases of cervical cancer each year in the United States and approximately 245,000 survivors. External beam radiation and brachytherapy are...
There are more than 13,000 new cases of cervical cancer each year in the United States and approximately 245,000 survivors. External beam radiation and brachytherapy are the front-line treatment modalities, and 60% of patients develop vaginal damage and constriction, i.e., stenosis of the vaginal vault, greatly impeding sexual function. The incidence of vaginal stenosis (VS) following radiotherapy (RT) for anorectal cancer is 80%. VS causes serious quality of life (QoL) and psychological issues, and while standard treatment using self-administered plastic dilators is effective, acceptance and compliance are often insufficient. Based on published patient preferences, we have pursued the design of a soft inflatable dilator for treating radiotherapy-induced vaginal stenosis (VS). The critical component of the novel device is the dilator balloon wall material, which must be compliant yet able to exert therapeutic lateral force levels. We selected a commercially available silicone elastomer and characterized its stress-strain characteristics and hyperelastic properties. These parameters were quantified using uniaxial tensile testing and digital image correlation (DIC). Dilator inflation versus internal pressure was modeled and experimentally validated in order to characterize design parameters, particularly the dilator wall thickness. Our data suggest that an inflatable silicone elastomer-based vaginal dilator warrants further development in the context of a commercially available, well-tolerated, and effective device for the graded, controlled clinical management of radiotherapy-induced VS.
PubMed: 38473522
DOI: 10.3390/ma17051050 -
Sexual Medicine Reviews Oct 2022Vaginal stenosis is a distressing side effect of radiation therapy that can impair quality of life. Dilator therapy is an option for patients undergoing pelvic... (Review)
Review
INTRODUCTION
Vaginal stenosis is a distressing side effect of radiation therapy that can impair quality of life. Dilator therapy is an option for patients undergoing pelvic radiotherapy to mitigate vaginal stenosis. Currently, the dilators given to patients by most hospitals are made of plastic, compared to silicone dilators which are available on the market for purchase.
OBJECTIVES
We conducted a systematic literature review to find information to guide clinical recommendations to pelvic radiotherapy patients on potential differences regarding the use of plastic vs silicone dilators with regard to efficacy, cost, and patient preferences.
METHODS
A systematic literature review was conducted in Embase, MEDLINE, and PubMed using Emtree terms. To be included in the review, papers needed to: focus on female patients undergoing radiation therapy, assess a vaginal dilator, measure any dilator intervention outcome, and specifically compare plastic vs silicone dilators for any measured outcome (either qualitative or quantitative).
RESULTS
The initial search yielded 195 articles. Two area experts, with a third expert for arbitration, read each article and found that none met all review inclusion criteria. No studies were found that compared silicone to plastic dilators with regard to efficacy in treating vaginal stenosis due to radiation therapy, no studies were found that compared cost or cost-effectiveness of the 2 dilator types, and no studies were found comparing patient preferences or experiences (eg, comfort, adherence, ease of use) between the 2 dilator types.
CONCLUSION
The materials used to create dilators have never been rigorously compared in the context of radiotherapy-related vaginal stenosis. Institutions and patients have no data to guide their choice. Significantly more research at the patient and institutional level is needed to explore the potential long-term quality of life and cost benefits of improved adherence with silicone dilator use, and to guide shared decision-making regarding dilator choice. Morgan O, Lopez MD, Martinez AJC, et al. Systematic Review of Comparisons Between Plastic and Silicone Dilators: Revealing a Knowledge Gap. Sex Med Rev 2022;10:513-519.
Topics: Constriction, Pathologic; Female; Humans; Plastics; Quality of Life; Silicones; Vagina
PubMed: 36030181
DOI: 10.1016/j.sxmr.2022.06.008 -
BMC Cancer Jun 2021We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. (Randomized Controlled Trial)
Randomized Controlled 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.
Topics: Administration, Topical; Adolescent; Adult; Aged; Brachytherapy; Brazil; Chemoradiotherapy; Constriction, Pathologic; Dilatation; Estrogens, Conjugated (USP); Female; Humans; Incidence; Middle Aged; Neoplasm Staging; Radiation Injuries; Severity of Illness Index; Testosterone Propionate; Treatment Outcome; Uterine Cervical Neoplasms; Vagina; Vaginal Diseases; Young Adult
PubMed: 34112100
DOI: 10.1186/s12885-021-08274-w -
Cancer Nursing 2018Vaginal brachytherapy, a common treatment of endometrial cancer, is associated with high rates of vaginal stenosis. Recommendations for vaginal dilator use to minimize... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Vaginal brachytherapy, a common treatment of endometrial cancer, is associated with high rates of vaginal stenosis. Recommendations for vaginal dilator use to minimize stenosis generally include 3 times per week for approximately 10 minutes per use. However, adherence rates range widely and are generally well less than 50%.
OBJECTIVES
The aims of this study were to assess feasibility of recruitment to a study of dilator use and test a theoretically driven enhanced educational program (EEP) to increase adherence.
METHODS
Eligibility included women treated with postoperative vaginal brachytherapy for stage I to IIIc endometrial cancer. Patients were randomized to either nurse-delivered standard institutional instruction or EEP.
RESULTS
Of eligible patients, 76% consented, 42 were randomized, and 69% completed the 6-month assessment. Mean age was 58.2 years; 48% were sexually active. There was no difference in adherence between arms. Overall, 20% and 8.3% were adherent to the prescribed use of 3 times per week, and 64% and 16% were adherent to use at least once per week at 6 weeks and 6 months, respectively. Adherence was greater among those motivated by vaginal health and having lower body mass index. Nonadherence was significantly higher among those who are college educated, in the EEP group, and with higher weight.
CONCLUSIONS
Feasibility of recruitment into a study of vaginal dilator use was high. Adherence was low, and there was no difference between groups. Adherence to vaginal dilator use requires novel interventions to test.
IMPLICATIONS FOR PRACTICE
Nursing education that includes how dilators may maintain vaginal health may improve use because it was a motivator for adherence in this study.
Topics: Adaptation, Psychological; Adult; Aged; Brachytherapy; Dilatation; Endometrial Neoplasms; Female; Humans; Middle Aged; Patient Compliance; Radiation Injuries; Sexual Behavior; Vagina
PubMed: 28437283
DOI: 10.1097/NCC.0000000000000500 -
International Journal of Women's Health 2017Treatment of gynecological cancer commonly involves pelvic radiation therapy (RT) and/or brachytherapy. A commonly observed side effect of such treatment is... (Review)
Review
Treatment of gynecological cancer commonly involves pelvic radiation therapy (RT) and/or brachytherapy. A commonly observed side effect of such treatment is radiation-induced vaginal stenosis (VS). This review analyzed the incidence, pathogenesis, clinical manifestation(s) and assessment and grading of radiation-induced VS. In addition, risk factors, prevention and treatment options and follow-up schedules are also discussed. The limited available literature on many of these aspects suggests that additional studies are required to more precisely determine the best management strategy of this prevalent group after RT.
PubMed: 28496367
DOI: 10.2147/IJWH.S106796