Preliminary results of a vaginal constraint for reducing G2 late vaginal complications after postoperative brachytherapy in endometrial cancer: a prospective analysis

Purpose To evaluate the preliminary results of the use of 68 Gy EQD2(α/β=3 Gy) as a dose limit to the lowest dose in the most exposed 2 cm3 of the vagina in order to reduce G2 late vaginal problems in postoperative endometrial carcinoma (EC). Methods From November 2016 to October 2019, 69 postoperative EC patients receiving vaginal brachytherapy (VBT) ± external beam radiotherapy (EBRT) were prospectively analyzed. The median EBRT dose was 45 Gy (range: 44–50.4 Gy), 1.8−2 Gy/day, 5 fractions(Fr)/week. VBT was administered with the following schedule: 1Fr of 7 Gy after EBRT and 2 daily Fr × 7.5 Gy in exclusive VBT. The dose was prescribed at 0.5 cm from the applicator surface with an active length of 2.5 cm; 56 patients were treated with vaginal cylinders (49–3.5 cm, 6–3 cm, and 1–2.5 cm) and 13 with the colpostat technique. The overall VBT dose was adjusted to meet the vaginal restriction of < 68 Gy EQD2(α/β=3 Gy) at 2 cm3. Late toxicity was prospectively assessed using RTOG scores for bladder and rectum, and the objective LENT-SOMA criteria for vagina. Results With a median follow-up of 31.0 months, no vaginal-cuff recurrences were found. Late toxicity: only 1G1(1.4%) rectal toxicity; 21G1(30.4%) and 3G2(4.3%) vaginal complications. Only one (1.4%) of 3 G2 manifested as vaginal shortening. Conclusions In postoperative EC patients treated with VBT, only one developed G2 vaginal stenosis with the use of 68 Gy EQD2(α/β=3 Gy) as a dose constraint. These preliminary results seem to indicate the value of this dose limit for reducing G2 vaginal stenosis. Nonetheless, these findings should be confirmed in a larger number of patients with longer follow-up.

Vaginal Dilator Use to Promote Sexual Wellbeing After Radiotherapy in Gynaecological Cancer Survivors: A Prospective Observational Study

Background: Since continuing advances in radiotherapy technology broaden the role of radiotherapy in the treatment of gynaecologic malignancies, the use of vaginal dilators has been introduced in order to mitigate the risk of vaginal stenosis. The main aims of this study were to investigate the vaginal dilator use efficacy in the treatment of radiation-induced vaginal stenosis and the vaginal dilator effect on sexual quality of life. Methods: We studied fifty-three patients with endometrial or cervical cancer. The participants were treated with radical or adjuvant external beam radiotherapy and/or brachytherapy. They were routinely examined at four time points post-radiotherapy when also they were asked to fill in a validated sexual function-vaginal changes questionnaire. A p-value less than 0.05 was considered statistically significant. Results: The vaginal stenosis grading score was decreased and the size of the vaginal dilator comfortably insertable was gradually increased throughout the year of vaginal dilator use while radiation-induced vaginal and sexual symptoms were improved throughout the year of VD use. All patients with initial grade 3 showed vaginal stenosis of grade 2 after 12 months of vaginal dilator use and 65.8% of the patients with grade 2 initial vaginal stenosis demonstrated final vaginal stenosis grade 1 while 77.8% of the participants with initial 1st size of vaginal dilators reached the 3rd vaginal dilator size after 12 months. Starting time of dilator therapy <= 3 months after the end of radiotherapy was associated with a significant decrease in vaginal stenosis. Additionally, there was an overall upward trend regarding patients’ satisfaction with their sexual life. Conclusion: Endometrial and cervical cancer survivors should be encouraged to use vaginal dilators for the treatment of vaginal stenosis and sexual rehabilitation after radiotherapy.

Vaginal Dilator Use to Promote Sexual Wellbeing After Radiotherapy in Gynaecological Cancer Survivors: A Prospective Observational Study

Background: Since continuing advances in radiotherapy technology broaden the role of radiotherapy in the treatment of gynaecologic malignancies, the use of vaginal dilators has been introduced in order to mitigate the risk of vaginal stenosis. The main aims of this study were to investigate the vaginal dilator use efficacy in the treatment of radiation-induced vaginal stenosis and the vaginal dilator effect on sexual quality of life. Methods: We studied fifty-three patients with endometrial or cervical cancer. The participants were treated with radical or adjuvant external beam radiotherapy and/or brachytherapy. They were routinely examined at four time points post-radiotherapy when also they were asked to fill in a validated sexual function-vaginal changes questionnaire. A p-value less than 0.05 was considered statistically significant. Results: The vaginal stenosis grading score was decreased and the size of the vaginal dilator comfortably insertable was gradually increased throughout the year of vaginal dilator use while radiation-induced vaginal and sexual symptoms were improved throughout the year of VD use. All patients with initial grade 3 showed vaginal stenosis of grade 2 after 12 months of vaginal dilator use and 65.8% of the patients with grade 2 initial vaginal stenosis demonstrated final vaginal stenosis grade 1 while 77.8% of the participants with initial 1st size of vaginal dilators reached the 3rd vaginal dilator size after 12 months. Starting time of dilator therapy <= 3 months after the end of radiotherapy was associated with a significant decrease in vaginal stenosis. Additionally, there was an overall upward trend regarding patients’ satisfaction with their sexual life. Conclusion: Endometrial and cervical cancer survivors should be encouraged to use vaginal dilators for the treatment of vaginal stenosis and sexual rehabilitation after radiotherapy.

Vaginal Vibrator as an alternative to Dilator in vaginal stenosis post pelvic radiotherapy in cervical cancer

Sexuality, post cancer treatment is the most unattended aspect of patient doctor communication. Quality of life in a cancer survivor should be addressed without any inhibitions so that patient does not suffer from any kind of psychological distress. Vaginal stenosis is a well-known side effect of pelvic radiotherapy, which we have tried to address in our study. We have used vaginal vibrator as an alternative to vaginal dilator in two of our patients on experimental basis post vaginal dilator. Both the patients gave feedback that vibrator is comparatively easy to use and less painful. On follow up examination visits, their per vaginal examinations were easy to perform and visibly improved vaginal mucosal health. Psychosexual adjustment is an important domain for better quality of life. Vaginal vibrator is an unorthodox method which we have explored and found some promising results, in overcoming vaginal stenosis and adhesions post pelvic radiation. However, this aspect of treatment as well as method needs to explored.

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.

Topical Estrogen, Testosterone, and Vaginal Dilator in the Prevention of Vaginal Stenosis after Radiotherapy in Women with Cervical Cancer

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, https://ensaiosclinicos.gov.br/rg/RBR-23w5fv