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.

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

Efficacy of vaginal dilator use in preventing vaginal stenosis among cervical and endometrial cancer patients underwent radiotherapy

Background: Vaginal dilators (VD) are effective in the prevention of vaginal stenosis in patients undergoing pelvic radiotherapy for gynaecological malignancies. This study was aimed to assess the efficacy of VD use in preventing post radiotherapy vaginal stenosis in cervical and endometrial cancer patients.Methods: A cohort study was designed among patients (20-70 years) with biopsy proven endometrial and cervical carcinoma who underwent pelvic radiotherapy were included. Patients with cervical carcinoma (FIGO stage-IA to IVA), endometrial carcinoma (FIGO stage IB grade III, FIGO stage II), histology of squamous cell carcinoma, adenocarcinoma and performance score-ECOG 1 were included in the study. Assessment included clinical history, general examination, pelvic examination at 3 monthly intervals till 1 year. Grading of vaginal stenosis was assessed using LENT SOMA grading system.Results: A total of 42 patients with 20 patients using vaginal dilators and 22 patients who refused to use VD were assigned. It was effective for 60% of VD users compared to 20% of nonusers (p=0.007) at 9 months follow up. While at 12 months follow up, it was effective for 58% of VD users compared to 16.6% of nonusers (p=0.066). Percent adherence was maximum in the 1st and 2ndquarter and declined to 61% by the 4th quarter. The total adherence was 97%.Conclusions: There was 55% vs 22.7% effectiveness to prevent the vaginal stenosis among VD users. All patients need proper counselling, motivation and support for regular usage of VD which will ultimately help in reducing the incidence of vaginal stenosis.

Hollow Prosthetic Vaginal Dilator - A Novel Technique

Certain rare congenital defects can occur during the prenatal development of the female reproductive system, resulting in an abnormal or absent vagina.1 It is a part of the female genital tract. It is muscular and an elastic organ with a soft epithelial lining making it susceptible to disruption during crucial times of organogenesis.1,2 There are different malformations that occur in the female genital organ, many of which are classified under the broader term “Müllerian duct anomalies”. 1,2 Müllerian agenesis is also referred to as congenital absence of the uterus and vagina (CAUV), müllerian aplasia (MA), genital renal ear syndrome (GRES), and Mayer-Rokitansky-KüsterHauser syndrome (MRKH). It has been considered as a sporadic anomaly, but the increase in familial cases now supports the hypothesis of a genetic cause characterised by a failure of the Müllerian ducts to develop, resulting in a missing uterus and variable malformations of the vagina.1-7 According to scientific data, its incidence is reported to be 1 in 4,000 to 10,000 females occurring due to a heterozygous transformation of WNT4 gene on chromosome 1p36.1-7 Additionally, traumatic vaginal injury in females, which is not uncommon, results in vaginal stenosis.5 This results in formation of scar tissue causing stricture of the vagina.5 Based on the family history, the patient must undergo medical examination supported by gynaecologic assistance to provide a sensitive and specific means of diagnosis.1,2 It is essential for the patients and their families to attend counselling before proceeding for treatment as this syndrome can cause severe psychological stress in a young woman. Patients with vaginal agenesis in MRKH syndrome can be treated by both surgical and non-surgical procedures and there has been no evidence of the superiority of one technique over another.6,11 Abbe–McIndoe operation is a common surgical method using split thickness skin graft for reconstruction and Frank’s dilators is a common nonsurgical method for the creation of neovagina.3,7 Frank's initial technique used hand-held vaginal dilators in the lithotomy position and had technical limitations such as uncomfortable positioning, loss of time spent during the process of dilation, and fatigue of patient's hands. Ingram's method overcame these difficulties by using the sitting position to take advantage of the patient's body weight.8,9 This method used vaginal dilators mounted on a specially designed bicycle seat stool that provided perineal pressure via the narrow and elevated anterior portion of the bicycle seat.10 Despite the favourable clinical outcome of this method, there were some practical difficulties in making and handling these in an outpatient clinic. However, irrespective of the procedure opted, prosthetic vaginal dilators or long-term vaginal stents are required to prevent the possible contraction of the reconstructed neovagina, to maintain vaginal width, depth and to avoid vaginal stenosis.6

Physiotherapeutic approach in genito-pelvic pain/penetration disorder

Background: Sexual dysfunctions constitute a public health problem that affects many women during all stages of life, being able to influence physical and mental health, interfering with quality of life. Physical therapy plays a fundamental role in addressing these dysfunctions, with simple and low cost resources, promoting significant results in these cases. Objective: To analyze the effectiveness of a physical therapy protocol on the sexual function of women with genital-pelvic pain/penetration disorder. Methods: Uncontrolled clinical trial, in which participated 15 women with a mean age of 28 ± 4.2 years, who had 16 physical therapy sessions twice a week. The pelvic physiotherapy protocol consisted of the application of electroanalgesia, perineal massage, kinesiotherapy and vaginal dilators. Sexual function was assessed by the Female Sexual Function Index (FSFI) and pain by the Visual Analog Scale (VAS). Results: Given the proposed treatment, the FSFI responded significantly (p=0.0003) with a median improvement that was 19.70 initially and increased to 28.40 later. The VAS also obtained significant improvement (p=0.0003), from the initial median of 8.00 to final 0.00. Conclusion: It is suggested that the physical therapy program has brought significant results in sexual function and pain in women with genital-pelvic pain/penetration disorder.

Simple and novel technique for fabrication of prosthetic vaginal dilators

Vaginal agenesis is one of the major congenital anomalies affecting women. Postoperative prosthetic vaginal dilators are indicated in patients treated surgically for vaginal agenesis. Although different dental materials such as acrylics and silicone-coated materials are used, addition silicones alone have never been used for the fabrication of prosthetic vaginal dilators. Addition silicone materials have advantages, such as high elastic recovery, high tear and tensile strengths, which aid in the definitive use of vaginal dilators. Vaginal dilators fabricated using addition silicone materials act as an efficient prosthesis in terms of function and ease of use in surgically treated vaginal agenesis patients.